Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women

Brief summary (registry, in English)

Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity. This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells.

What you commit to

• Study type: Interventional
• Participants enrolled: 54
• From 1 Sept 2024 to the primary completion date, 30 Jun 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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Related publications

• Betaine supplementation modulates mitochondrial and redox-related adaptations in premenopausal women with overweight: a randomized controlled trial.Eur J Nutr · 2026 · PMID 42841999
• Betaine supplementation has no effect on sex hormones in premenopausal women with overweight or obesity: A randomized controlled trial.Clin Nutr ESPEN · 2026 · PMID 42498161