Tier 2 — strong

Betaine, a promising new agent for patients with nonalcoholic steatohepatitis: results of a pilot study

M F Abdelmalek, P Angulo, R A Jorgensen, P B Sylvestre, K D Lindor
The American journal of gastroenterology 2001 96(9):2711-2717

Bibliography

PubMed
PMID 11569700
DOI
10.1111/j.1572-0241.2001.04129.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 pilot
ModelHuman participants
Sample10 adults with NASH; 7 completed one year
InterventionBetaine anhydrous oral solution in two daily doses
Duration12 months
EndpointsLiver enzymes; Liver histology; Tolerability

What the study showed, in plain terms

Published in 2001, this source examined metabolic health and liver trials. Design: Open-label pilot. Sample/model: 10 adults with NASH; 7 completed one year. The exposure or intervention was Betaine anhydrous oral solution in two daily doses. Follow-up or treatment period: 12 months.

Liver enzymes and biopsy measures improved in several participants; transient gastrointestinal symptoms occurred.

No placebo group, substantial attrition and only seven long-term completers. Later controlled evidence did not confirm a clear histological benefit.

Continue with TMG Data Center

Continue with TMG and Liver Health: Human Trials Behind the Claims

Key findings

  • Liver enzymes and biopsy measures improved in several participants; transient gastrointestinal symptoms occurred.
  • The recorded outcome domains were Liver enzymes; Liver histology; Tolerability.
  • The result applies to the tested exposure: Betaine anhydrous oral solution in two daily doses; 12 months.

What this study can and cannot tell us

  • No placebo group, substantial attrition and only seven long-term completers. Later controlled evidence did not confirm a clear histological benefit.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Indexed abstract and bibliographic data. Missing method details, funding information or participant denominators are not inferred.

Related papers in the corpus

Tier 2
Betaine for nonalcoholic fatty liver disease: results of a randomized placebo-controlled trial
Manal F Abdelmalek et al. · Hepatology (Baltimore, Md.) · 2009
Tier 2
Pilot trials of oral betaine in participants with metabolic dysfunction-associated steatotic liver disease and elevated alanine aminotransferase
Andrew S Lim et al. · Hepatology (Baltimore, Md.) · 2026
Tier 4
Betaine in Metabolic Dysfunction-Associated Steatotic Liver Disease: Mechanisms of Action and Therapeutic Potential
Tatjana Radosavljevic et al. · Antioxidants (Basel, Switzerland) · 2026
Tier 2
Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes
Ana Maria Grizales et al. · The Journal of clinical endocrinology and metabolism · 2018
Tier 2
Betaine supplementation decreases plasma homocysteine concentrations but does not affect body weight, body composition, or resting energy expenditure in human subjects
Ursula Schwab et al. · The American journal of clinical nutrition · 2002

Citation network

Articles citing this research paper

1 article

Biohack Blueprint analyses that reference this study in their evidence base.

Editorial review

Reviewed by the Biohack Blueprint research team

Last verified

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