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Betaine Hydrochloride

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Betaine Hydrochloride does in the body

Homocystinuria to decrease elevated homocysteine blood concentrations

CYSTADANE acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria. It is a metabolite of choline and is present in small amounts in foods such as beets, spinach, cereals, and seafood. 12.2 Pharmacodynamics CYSTADANE was observed to lower plasma homocysteine concentrations in three types of homocystinuria, including CBS deficiency; Patients have taken CYSTADANE for many years without evidence of tolerance. There has been no demonstrated correlation between Betaine concentrations and homocysteine concentrations.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · V3ZLN1NK3G · read 2026-08-29

  • The supplement label database classes it as non-nutrient/non-botanical, under the name Betaine Nitrate.

    NIH Dietary Supplement Label Database · 3149 · read 2026-08-29

Where each sentence above came from

No plain explanation of what this changes is stored. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 101 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Enzyme

An enzyme is a protein that speeds up one chemical change.

A picture of it, and where the picture fails

An enzyme is like a machine on a production line doing one cut.

Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.

What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.

A catalytic protein that lowers the activation energy of a specific reaction.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 23 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved3 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
StrengthNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer1 registered performance measure of this kind.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
CholesterolNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
insulin sensitivity; plasma glucose concentration; plasma insulin concentration
Strength
strength
Body weight
body composition
Cholesterol
lipid profile

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
3 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Oral microbiota profile at baseline and after 4 months

The study did not show it

Who was studied
NCT05463484
How many people
100
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot

Meal Tolerance Assessment

The study did not show it

Who was studied
NCT01293604
How many people
69
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot

Change in Fasting Insulin Concentrations

The study did not show it

Who was studied
NCT02298725
How many people
52
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot

Change individual quality of life

The study did not show it

Who was studied
NCT06286748
How many people
25
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route.

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • NIH Dietary Supplement Label Database · a recorded source, not a stored snapshot
What we know
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.2 registered measures of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.2 registered measures of this kind.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.11 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.1 registered measure inside human tissue.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Drosophila (fruit fly), Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • urinary oxalate excretion
  • strength
  • urinary monomethyl arsenic
  • urinary inorganic arsenic
  • urinary dimethyl arsenic
  • insulin sensitivity
  • plasma fetal growth factor 21 concentration
  • plasma choline concentration
  • plasma glucose concentration
  • plasma insulin concentration

and 4 more.

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (9)
  • endothelial function
  • thermoregulation
  • stress
  • sweat rate
  • sweat content
  • subjective measures
  • asia
  • body mass
  • lipid profile

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • & USAGE Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of CYSTADANE have been established in pediatric patients.”

    US prescribing information · 31a684d0-cd98-4e46-b43a-ccbd17c41559 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available data from a limited number of published case reports and postmarketing experience with CYSTADANE use in pregnancy have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.”

    US prescribing information · 31a684d0-cd98-4e46-b43a-ccbd17c41559 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of betaine in human or animal milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · 31a684d0-cd98-4e46-b43a-ccbd17c41559 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Betaine Hydrochloride appears in spontaneous reports to regulators. Across the 2 most-reported reaction terms, 3 reaction mentions were counted. One report can name several reactions.

The recorded terms (2)
  • covid-19 — 2 reaction mentions
  • electrocardiogram q wave abnormal — 1 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 1529 marketed supplement labels list this ingredient, classed as non-nutrient/non-botanical and other combinations.

    NIH Dietary Supplement Label Database · 178895 · read 2026-08-29

  • Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 178895 · read 2026-08-29

  • Cystadane is oral at 3 DOSAGE FORMS AND STRENGTHS CYSTADANE is a white, granular, hygroscopic powder for oral solution available in bottles containing 180 grams of betaine anhydrous., recorded as fda label in effect 2026-04-24 in the United States.

    US prescribing information · 31a684d0-cd98-4e46-b43a-ccbd17c41559 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Betaine Hydrochloride studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

What would answer it

A stored source that records it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Betaine Hydrochloride are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
V3ZLN1NK3G
CAS registry number
93778-42-8
PubChem compound
3022334
EMA substance identifier
300000052763
European Chemicals Agency number
298-179-5

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • The path through the body — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • How this medicine reached us — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (13)

What did Betaine Hydrochloride's largest trial (100 people) and its longest (12 years) measure?


100 people in Betaine Hydrochloride's largest registered study, 12 years in its longest registered window, measuring Plasma Fetal Growth Factor 21 (FGF21) concentration. ClinicalTrials.gov · 2026-09-01

14 na, 8 phase2, 2 phase3, 1 early phase1, 1 phase1, 1 phase4; NCT03073343; 2025-12-30; no ageing endpoint recorded. Last human test completed 2025, NCT06344377.

Interpretation These counts include studies where Betaine Hydrochloride was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • na
    14
  • phase2
    8
  • phase3
    2
  • early phase1
    1
  • phase1
    1
  • phase4
    1
1 more recorded row
  • Last recorded human test NCT06344377
    2025-10-30

recorded 2026-09-01 · last checked 2026-09-04

From C. elegans to human: where has Betaine Hydrochloride shown lifespan?


C. elegans: mechanism-only, Drosophila: lifespan, mouse: mechanism-only and human: biomarker (25): the rungs where Betaine Hydrochloride has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Plasma Fetal Growth Factor 21 (FGF21) concentration — the recorded outcome words.

Yeast C. elegans mechanism-onlyDrosophila lifespanMouse mechanism-onlyRat Dog Non-human primate Human biomarker
Show the evidence
  • C. elegans
    mechanism-only
  • Drosophila
    lifespan
  • mouse
    mechanism-only
  • human NCT02118142
    biomarker; Plasma Fetal Growth Factor 21 (FGF21) concentration; 25

recorded 2026-09-01 · last checked 2026-09-04

Why did Betaine Hydrochloride's trial NCT00882193 stop?


1 recorded trial of Betaine Hydrochloride stopped. ClinicalTrials.gov · 2026-09-01

"new medications with improved response released"; 1 of 25 registered studies

Show the evidence
  • Trial NCT00882193
    terminated; "new medications with improved response released"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Betaine Hydrochloride used Betaine (588 mg qam and 412 mg qpm) — over how long?


Human studies of Betaine Hydrochloride used "Betaine (588 mg qam and 412 mg qpm)". ClinicalTrials.gov · 2026-09-01

5 recorded entries; human; also "Betaine (1000 mg BID)", "Betaine Hydrochloride 1500mg", "Betaine Hydrochloride 3000mg"

Show the evidence

human

  • NCT02403804
    Betaine (588 mg qam and 412 mg qpm)
  • NCT02403804
    Betaine (1000 mg BID)
  • NCT02758015
    Betaine Hydrochloride 1500mg
  • NCT02758015
    Betaine Hydrochloride 3000mg
  • NCT02758015
    Betaine Hydrochloride 4500mg

recorded 2026-09-01 · last checked 2026-09-04

More Betaine Hydrochloride was worse in human: at what point?


Hormetic in human: "Based on the concentration ratios of various compounds and comparison of four hormetic characteristic parameters to those of various mixture rays, it was found that the compound betaine (BET) is a key compound affecting the hormesis of mixtures." Europe PMC · dose-response search · 2026-07-30

6 recorded sentences naming Betaine Hydrochloride; hormetic, U-shaped, biphasic, dose-response

Show the evidence
  • hormetic PMID 36155044
    "Based on the concentration ratios of various compounds and comparison of four hormetic characteristic parameters to those of various mixture rays, it was found that the compound betaine (BET) is a key compound affecting the hormesis of mixtures."

U-shaped

  • PMID 37904202
    "Interestingly, a U-shaped association was observed between serum betaine and digestive cancers, with a turning point of 5.01 mmol/L for betaine (betaine < 5.01 mmol/L, OR = 0.82, 95%CI = 0.59-1.14, p = 0.228; betaine ≥ 5.01 mmol/L, OR = 1.08, 95%CI = 1.01-1.17, p = 0.036)."
  • PMID 37904202
    "High serum betaine was associated with increased risk of total cancer and lung cancer, and a U-shaped association was found with the risk of digestive cancers, with a turning point at about 5.01 mmol/L."
  • biphasic PMID 42532284
    "Herein, a novel amine-free temperature-responsive biphasic deep eutectic solvent (TRDES) system, composed of betaine, levulinic acid, and octanoic acid (BLevA-OA), was constructed for the integrated extraction and separation of polyphenols from Moringa oleifera Lam."
  • dose-response PMID 41616568
    "Several metabolites [specifically alanine, log-transformed C18:1-acylcarnitine, and betaine (all P overall < .05, P non-linear > .05)] showed linear dose-response relationships with fibrosis risk."
  • biphasic PMID 42107306
    "To address these limitations, aqueous biphasic systems (ABS) comprising glycine-betaine analogue ionic liquids (AGB-ILs) are introduced as a green sample preparation strategy for the selective depletion of high-abundance serum proteins."

recorded 2026-07-30 · last checked 2026-09-04

Could one person measure Betaine Hydrochloride's effect on urinary oxalate excretion?


Urinary oxalate excretion: measured in Betaine Hydrochloride's trials.

Interpretation urinary oxalate excretion is the recorded endpoint.

Show the evidence

biomarkers

  • urinary oxalate excretion; 2026-09-01
  • strength; 2026-09-01
  • urinary monomethyl arsenic; 2026-09-01
  • urinary inorganic arsenic; 2026-09-01
  • urinary dimethyl arsenic; 2026-09-01
  • endothelial function; 2026-09-01
14 more recorded rows
  • biomarkers
    insulin sensitivity; 2026-09-01
  • biomarkers
    plasma fetal growth factor 21 concentration; 2026-09-01
  • biomarkers
    plasma choline concentration; 2026-09-01
  • biomarkers
    plasma glucose concentration; 2026-09-01
  • biomarkers
    plasma insulin concentration; 2026-09-01
  • biomarkers
    plasma adiponectin concentration; 2026-09-01
  • biomarkers
    thermoregulation; 2026-09-01
  • biomarkers
    stress; 2026-09-01
  • biomarkers
    sweat rate; 2026-09-01
  • biomarkers
    sweat content; 2026-09-01
  • biomarkers
    subjective measures; 2026-09-01
  • biomarkers
    asia; 2026-09-01
  • biomarkers
    body composition; 2026-09-01
  • biomarkers
    body mass; 2026-09-01
  • human trials at or under30
    17
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    2; NCT00882193; EARLY_PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; TERMINATED

Which of asia, body composition and body mass did Betaine Hydrochloride's trials measure?


asia, body composition and body mass lead 23 outcome terms across Betaine Hydrochloride's trials. ClinicalTrials.gov · 2026-09-01

urinary inorganic arsenic, urinary dimethyl arsenic, endothelial function, insulin sensitivity, plasma fetal growth factor 21 concentration and plasma choline concentration follow.

Show the evidence
  • urinary oxalate excretion
    1
  • strength
    1
  • urinary monomethyl arsenic
    1
  • urinary inorganic arsenic
    1
  • urinary dimethyl arsenic
    1
  • endothelial function
    1
14 more recorded rows
  • insulin sensitivity
    1
  • plasma fetal growth factor 21 concentration
    1
  • plasma choline concentration
    1
  • plasma glucose concentration
    1
  • plasma insulin concentration
    1
  • plasma adiponectin concentration
    1
  • thermoregulation
    1
  • stress
    1
  • sweat rate
    1
  • sweat content
    1
  • subjective measures
    1
  • asia
    1
  • body composition
    1
  • body mass
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Betaine Hydrochloride's 4 ongoing trials reports first?


4 registered trials of Betaine Hydrochloride are open; earliest completion 2026-10. ClinicalTrials.gov · 2026-09-01

Change from birth weight-for-length z score at 1 month; ASIA Score; latest 2035-12-31

Show the evidence

Trial

  • NCT04633044
    "Maternal Betaine Supplementation During Breastfeeding"; n 47; "Change from birth weight-for-length z score at 1 month"; 2026-10
  • NCT06308367
    "The Therapeutic Effect of Betaine in Syringomyelia"; n 30; "ASIA Score"; 2028-03
  • NCT06881511
    "Exploratory Study on the Efficacy of Betaine Hydrochloride in Treating Autoimmune Gastritis"; n 100; "Serum Gastrin Levels"; 2026-12-31
  • NCT07276204
    "Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)"; n 70; "NIS2+"; 2035-12-31

recorded 2026-09-01 · last checked 2026-09-04

Which 11 trials of Betaine Hydrochloride posted no result?


Posted no result
11 of 11 completed trials
Registrations
NCT00586911, NCT00310336, NCT01048307, NCT01213719, NCT02118142 and NCT02403804, and 5 more
Completion dates
oldest 2006-06; newest 2024-09-01
Show the evidence

Trial

  • NCT00586911
    2006-06
  • NCT00310336
    2009-09
  • NCT01048307
    2010-07
  • NCT01213719
    2011-07
  • NCT02118142
    2014-07
  • NCT02403804
    2015-09-29
5 further recorded trials
  • NCT02404337
    2018-02
  • NCT02758015
    2018-03-26
  • NCT05790070
    2021-07-30
  • NCT04585295
    2023-12-15
  • NCT06042270
    2024-09-01

At the median, Betaine Hydrochloride's trials enrolled 23 people — anything larger?


Median enrolment
23
Largest enrolment
100
Registered trials counted
25

What do 3 spontaneous reports say about Betaine Hydrochloride — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Betaine Hydrochloride appears in spontaneous reports to regulators. Across the 2 most-reported reaction terms, 3 reaction mentions were counted: covid-19 2; electrocardiogram q wave abnormal 1. open-targets-adr · CHEMBL1201130 · 2026-06-24

Show the evidence
  • covid-19
    2
  • electrocardiogram q wave abnormal
    1

recorded 2026-06-24 · last checked 2026-09-04

Was Betaine Hydrochloride studied with exercise?


exercise is named in Betaine Hydrochloride's label sentences: "Moreover, apoptosis in the betaine trial was significantly lower immediately after and 3 h after exercise compared with the placebo trial." openfda-label+europepmc · 2020-11-27

1 recorded statement; exercise

Show the evidence
  • exercise
    Moreover, apoptosis in the betaine trial was significantly lower immediately after and 3 h after exercise compared with the placebo trial.

recorded 2020-11-27 · last checked 2026-09-04

What is recorded about Betaine Hydrochloride and mTOR?


"Our findings proposed the possible mechanism for appetite regulation through autophagy via AMPK/mTOR, and demonstrated the feasibility of betaine as an aquafeed additive to regulate appetite and intermediary metabolism in fish." — where Betaine Hydrochloride and mTOR appear together. Europe PMC · pathway abstract search · 2026-02-01

mTOR, AMPK, autophagy, sirtuin, NAD+; PMID 38623237, 41532950, 39434620, 38222825

Show the evidence
  • mTOR PMID 38623237
    "Our findings proposed the possible mechanism for appetite regulation through autophagy via AMPK/mTOR, and demonstrated the feasibility of betaine as an aquafeed additive to regulate appetite and intermediary metabolism in fish."
  • AMPK PMID 38623237
    "Our findings proposed the possible mechanism for appetite regulation through autophagy via AMPK/mTOR, and demonstrated the feasibility of betaine as an aquafeed additive to regulate appetite and intermediary metabolism in fish."
  • autophagy PMID 38623237
    "Our findings proposed the possible mechanism for appetite regulation through autophagy via AMPK/mTOR, and demonstrated the feasibility of betaine as an aquafeed additive to regulate appetite and intermediary metabolism in fish."
  • AMPK PMID 41532950
    "However, Betaine's beneficial effects were diminished by AMPK inhibitor compound C. In conclusion, Betaine enhances porcine oocyte IVM and early embryo development by enhancing the antioxidant capacity and mitochondrial function pathway."
  • mTOR PMID 39434620
    "Our findings demonstrated that betaine supplementation extends lifespan, primarily through pathways associated with the forkhead box transcription factor (FoxO) signaling pathway, the p38-mitogen-activated protein kinase (MAPK) signaling pathway, autophagy, the longevity regulating pathway, and the target of rapamycin (mTOR) signaling pathway."

autophagy

  • PMID 39434620
    "Our findings demonstrated that betaine supplementation extends lifespan, primarily through pathways associated with the forkhead box transcription factor (FoxO) signaling pathway, the p38-mitogen-activated protein kinase (MAPK) signaling pathway, autophagy, the longevity regulating pathway, and the target of rapamycin (mTOR) signaling pathway."
  • PMID 38222825
    "To determine the role of autophagy in the improvement of NAFLD, chloroquine (CQ), an autophagy inhibitor, was injected into the mice fed a CDAHFD and betaine (0.5 % in drinking water)."
  • sirtuin PMID 35597887
    "PCR assays revealed the down-regulation of Sirtuin1 (SIRT1), a NAD<sup>+</sup>-dependent deacetylase that mediates metabolic responses, in the hippocampus of Aβ<sub>25-35</sub>-injected mice, whereas betaine intake prevented memory deficits as well as the decrease of hippocampal SIRT1 expression in Aβ<sub>25-35</sub>-injected mice."
  • NAD+ PMID 35597887
    "PCR assays revealed the down-regulation of Sirtuin1 (SIRT1), a NAD<sup>+</sup>-dependent deacetylase that mediates metabolic responses, in the hippocampus of Aβ<sub>25-35</sub>-injected mice, whereas betaine intake prevented memory deficits as well as the decrease of hippocampal SIRT1 expression in Aβ<sub>25-35</sub>-injected mice."

sirtuin

  • PMID 35597887
    "Further, sirtinol, an inhibitor of the Sirtuin family, blocked the preventive effect of betaine against memory deficits."
  • PMID 35597887
    "On the other hand, resveratrol, the potent compound that activates SIRT1, also prevented memory impairments in Aβ<sub>25-35</sub>-injected mice, suggesting that SIRT1 plays a causative role in the preventive effect of betaine against memory deficits caused by Aβ exposure."
  • AMPK PMID 41841787
    "Transcriptomic and metabolomic analyses revealed that TCWPs ameliorated the abnormal glucose and lipid metabolism by regulating the expression level of key genes such as Pck1, Sik1, and Cds2 (P < 0.05), as well as the key metabolites such as 1-palmitoyl-2-linoleoyl-glycophosphorylcholine (down-regulated) by modulating the linoleic acid metabolism pathway and betaine (up-regulated) by activating…"
  • mTOR PMID 33556906
    "In conclusion, betaine supplementation improved serum lipid metabolism, immune response, and increased the testicular antioxidant capacity of Hu sheep, which might be regulated via mTOR signaling pathway."

recorded 2026-02-01 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201130
PubChem CID
11545
CAS number
590-46-5
RxCUI
81965
InChIKey
KWIUHFFTVRNATP-UHFFFAOYSA-O
Also called
Betaine Nitrate
Salt form
Betaine hcl, Betaine anhydrous
Also called
Betainum muriaticum, BETAINE, Abromine, BETAINE HYDROCHLORIDE [MART.], BETAINE HYDROCHLORIDE [ORANGE BOOK], BETAINE HYDROCHLORIDE [USP IMPURITY], BETAINE HYDROCHLORIDE [USP MONOGRAPH], BETAINE HYDROCHLORIDE [USP-RS], BETAINE HYDROCHLORIDE [VANDF], BETAINUM MURIATICUM [HPUS], Betaine hydrochloride [WHO-DD]
Development code
NSC-32191, NSC-3976, FEMA NO. 4223, NSC-166511
Trade name
Acidol pepsin, Amversio, Cystadane, Dr.jucre Rebirth Activating Toner, Cystadane / Dr.jucre Rebirth Activating Toner
Component
Betaine Nitrate
Sources (10)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
4 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 10 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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