Tier 2 — strong

Pharmacokinetics of oral betaine in healthy subjects and patients with homocystinuria

Bernd C Schwahn, Dieter Hafner, Thomas Hohlfeld, Nina Balkenhol, Maurice D Laryea, Udo Wendel
British journal of clinical pharmacology 2003 55(1):6-13

Bibliography

PubMed
PMID 12534635
PubMed Central
PMC1884185
DOI
10.1046/j.1365-2125.2003.01717.x
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignOpen-label pharmacokinetic study
ModelHuman participants
Sample12 healthy men plus a small homocystinuria group
InterventionSingle betaine 50 mg/kg and repeated 50 mg/kg twice daily
DurationSingle-dose sampling and 5-day repeated dosing
EndpointsAbsorption; Elimination; Dimethylglycine

What the study showed, in plain terms

Published in 2003, this source examined food sources, absorption and nutrient metabolism. Design: Open-label pharmacokinetic study. Sample/model: 12 healthy men plus a small homocystinuria group. The exposure or intervention was Single betaine 50 mg/kg and repeated 50 mg/kg twice daily. Follow-up or treatment period: Single-dose sampling and 5-day repeated dosing.

Betaine was absorbed rapidly, mostly cleared through metabolism, and accumulated during repeated dosing. Elimination was slower after repeated exposure.

Small pharmacokinetic study; medical dosing in homocystinuria cannot be transferred directly to healthy supplement users.

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Key findings

  • Betaine was absorbed rapidly, mostly cleared through metabolism, and accumulated during repeated dosing.
  • Elimination was slower after repeated exposure.
  • The recorded outcome domains were Absorption; Elimination; Dimethylglycine.
  • The result applies to the tested exposure: Single betaine 50 mg/kg and repeated 50 mg/kg twice daily; Single-dose sampling and 5-day repeated dosing.

What this study can and cannot tell us

  • Small pharmacokinetic study; medical dosing in homocystinuria cannot be transferred directly to healthy supplement users.
  • A change in blood exposure or a metabolic marker is not a demonstrated improvement in symptoms, disease events or lifespan. The tested formulation and co-administered medicines matter.
  • Source basis: Indexed abstract and bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology