Tier 2 — strong

A novel nutritional supplement to reduce plasma homocysteine in nonpregnant women: A randomised controlled trial in The Gambia

Philip T James, Ousubie Jawla, Nuredin I Mohammed, Kabiru Ceesay, Fatai M Akemokwe, Bakary Sonko, Ebrima A Sise, Andrew M Prentice, Matt J Silver
PLoS medicine 2019 16(8):e1002870

Bibliography

PubMed
PMID 31408467
PubMed Central
PMC6691988
DOI
10.1371/journal.pmed.1002870
Funding
Reported funding/support: http://dx.doi.org/10.13039/501100000265Medical Research CouncilMC_EX_MR/M01424X/1http://orcid.org/0000-0001-5389-451XPrenticeAndrew M.http://dx.doi.org/10.13039/501100000265Medical Research CouncilMC-A760-5QX00http://orcid.org/0000-0001-5389-451XPrenticeAndrew M.This work was funded by the UK Medical Research Council (MRC) grant to AMP for the "Impact of maternal diet on the epigenome" (MC_EX_MR/M01424X/1) and a core funding grant to AMP from the MRC/UK Department for the International Development (DFID) Concordat agreement (MC-A760-5QX00). DSM Nutritional Products South Africa provided the UNIMMAP tablets as an in-kind contribution. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests
Reported disclosure: The authors have declared that no competing interests exist.

Study snapshot

DesignRandomized controlled trial
ModelHuman participants
Sample298 nonpregnant Gambian women aged 18-45
InterventionDrink with betaine 4 g/day plus folate, B12 and B2 versus UNIMMAP or no supplement
Duration12 weeks
EndpointsHomocysteine; Blood pressure; Adverse events

What the study showed, in plain terms

Published in 2019, this source examined homocysteine, methylation and vascular function. Design: Randomized controlled trial. Sample/model: 298 nonpregnant Gambian women aged 18-45. The exposure or intervention was Drink with betaine 4 g/day plus folate, B12 and B2 versus UNIMMAP or no supplement. Follow-up or treatment period: 12 weeks.

The drink reduced homocysteine by approximately 23.6% versus control and by 8.8% relative to UNIMMAP. Blood pressure and pulse did not improve.

A multi-nutrient intervention targeting a metabolic marker; pregnancy outcomes and offspring health were not tested.

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Continue with TMG and Homocysteine: How Much Can Betaine Lower It?

Key findings

  • The drink reduced homocysteine by approximately 23.6% versus control and by 8.8% relative to UNIMMAP.
  • Blood pressure and pulse did not improve.
  • The recorded outcome domains were Homocysteine; Blood pressure; Adverse events.
  • The result applies to the tested exposure: Drink with betaine 4 g/day plus folate, B12 and B2 versus UNIMMAP or no supplement; 12 weeks.

What this study can and cannot tell us

  • A multi-nutrient intervention targeting a metabolic marker; pregnancy outcomes and offspring health were not tested.
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Accessible full-text extract plus indexed 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