NCT06344377

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

The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Poznan University of Life Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betaine	Betaine supplemented for 8 weeks
DIETARY_SUPPLEMENT	Placebo	Placebo supplementation for 8 weeks

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-06-30
• Completion: 2025-10-30
• First posted: 2024-04-03
• Last updated: 2025-11-24

Locations

1 site across 1 country: Poland