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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344377
• Other study ID #: BETadiposeWOMEN
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 21, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2024
• Source: Poznan University of Life Sciences
• Contact: Agata Chmurzynska
• Phone: +48 618466181
• Email: agata.chmurzynska[@]up.poznan.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• females

• age: 18-45 years

• pre-menopausal

• overweight or obese: BMI >25 kg/m2

• waist circumference > 80 cm

Exclusion Criteria:

• males

• age <18 or >45 years

• perimenopausal or postmenopausal

• BMI < 25 kg/m2

• waist circumference < 80 cm

• betaine administration for 3 months prior to study

• pregnant or breastfeeding

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Betaine
Betaine supplemented for 8 weeks
• Placebo
Placebo supplementation for 8 weeks

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Life Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	Body composition will include percent body fat and lean body mass measured with air displacement plethysmography	8 weeks, three measurements: at week 0, 4 and 8
Primary	Body mass	Measured in kg	8 weeks, three measurements: at week 0, 4 and 8
Primary	Waist and hips circumference	Measured in cm	8 weeks, three measurements: at week 0, 4 and 8
Primary	Lipid profile	Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol	8 weeks, two measurements: at week 0 and 8
Primary	Gene expression	Included genes relate to lipid metabolism in adipose tissue: PPARG, CD36, FABP4, UCP1, PPARGC1A, LEP, ADIPOQ, INSR, IRS1, DGAT2, SREBF1, ELOVL5 , FADS3, FASN	8 weeks, two measurements: at week 0 and 8
Secondary	Liver function test	concentraions of enzymes: ALT, AST, GGTP, ALP	8 weeks, two measurements: at week 0 and 8
Secondary	Dietary intake	Based on food diary	8 weeks, two measurements: at week 0 and 8