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

NCT06344377 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-11-24

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Betaine

Betaine supplemented for 8 weeks

DIETARY_SUPPLEMENT

Placebo

Placebo supplementation for 8 weeks

Sponsors & Collaborators

  • Poznan University of Life Sciences

    lead OTHER

Principal Investigators

  • Agata Chumrzynska · Poznan University of Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-06-30
Completion
2025-10-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06344377 on ClinicalTrials.gov