Methyl-donor medicine and supplement compound · Fact sheet
Betaine
Also known as Trimethylglycine · TMG · Betaine anhydrous · Cystadane
Betaine, or trimethylglycine, has an approved prescription product for homocystinuria. That use does not establish that TMG supplements improve longevity, exercise performance or fatty liver.
What is Betaine?
Betaine is a methyl donor involved in conversion of homocysteine to methionine.
Betaine anhydrous and betaine hydrochloride are different preparations; anhydrous-drug labeling does not apply to digestive betaine-HCl products.
Benefits & claims
Interest spans homocysteine lowering and methyl metabolism, but a biochemical role does not establish broad benefit from supplementation.
What the evidence supports
- Cystadane lowers homocysteine in its specific metabolic-disease population.
- A prediabetes trial found little metabolic effect despite substantial changes in a downstream metabolite.
- A fatty-liver trial did not improve its principal disease-activity or fibrosis measures.
Research areas
- Homocystinuria
- Homocysteine metabolism
- Investigational metabolic supplementation
Dosage & frequency
Product-specific label informationCystadane labeling supplies a homocystinuria reference, not a TMG wellness schedule.
Cystadane betaine anhydrous for oral solution
Adults and children aged at least three years with label-defined homocystinuria
- Amount
- 3 g per administration; 6 g/day total
- Frequency
- Twice daily, with gradual adjustment according to biochemical response
- Route studied or labeled
- Oral solution
Specialist monitoring of homocysteine is required; methionine monitoring is particularly important in CBS deficiency. Younger-child starting doses and individualized adjustments are omitted. No fixed treatment duration is specified.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- Betaine is a methyl donor involved in conversion of homocysteine to methionine.
Formulation differences
- Betaine anhydrous and betaine hydrochloride are different preparations; anhydrous-drug labeling does not apply to digestive betaine-HCl products.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- General wellness benefit in people without the approved disorders
- Long-term supplement effects
- Whether other formulations reproduce anhydrous betaine exposure
Side effects & risks
- Cystadane can worsen elevated methionine in CBS deficiency, and cerebral edema has been reported in that setting.
- Nausea and gastrointestinal distress are reported; safety requires disease-specific biochemical monitoring.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Moderate human evidenceLabel-supported homocystinuria treatment is established. Separate randomized studies in fatty liver and prediabetes did not substantiate broad metabolic expectations.
Studies
Randomized fatty-liver trial; limited disease-activity benefit.
Prediabetes trial; little metabolic effect.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Cystadane betaine anhydrous for oral solution is approved to treat homocystinuria and lower elevated homocysteine in defined CBS, MTHFR or cobalamin-related disorders. General wellness products and claims are outside that approval.
Approved uses
- Cystadane for homocystinuria due to CBS deficiency, MTHFR deficiency or cobalamin-cofactor metabolism defects.
FDA approved for a specific product and use
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
Open questions
- General wellness benefit in people without the approved disorders
- Long-term supplement effects
- Whether other formulations reproduce anhydrous betaine exposure
Summary
A fatty-liver trial did not improve its principal disease-activity or fibrosis measures.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- nihCystadane prescribing information
Current label for homocystinuria, age-specific amounts and methionine/cerebral-edema warnings.
- pubmedBetaine for nonalcoholic fatty liver disease: results of a randomized placebo-controlled trial.
Randomized fatty-liver trial; limited disease-activity benefit.
- pubmedMetabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes.
Prediabetes trial; little metabolic effect.