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Clinical Trials/NCT06344377
NCT06344377
Completed
Not Applicable

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

Poznan University of Life Sciences1 site in 1 country54 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight and Obesity
Sponsor
Poznan University of Life Sciences
Enrollment
54
Locations
1
Primary Endpoint
Lipid profile
Status
Completed
Last Updated
5 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
October 30, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Poznan University of Life Sciences
Responsible Party
Principal Investigator
Principal Investigator

Agata Chmurzyńska

Professor

Poznan University of Life Sciences

Eligibility Criteria

Inclusion Criteria

  • age: 18-45 years
  • pre-menopausal
  • overweight or obese: BMI \>25 kg/m2
  • waist circumference \> 80 cm

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Lipid profile

Time Frame: 8 weeks, two measurements: at week 0 and 8

Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol

Body mass

Time Frame: 8 weeks, three measurements: at week 0, 4 and 8

Measured in kg

Gene expression

Time Frame: 8 weeks, two measurements: at week 0 and 8

Included genes relate to lipid metabolism in adipose tissue: PPARG, CD36, FABP4, UCP1, PPARGC1A, LEP, ADIPOQ, INSR, IRS1, DGAT2, SREBF1, ELOVL5 , FADS3, FASN

Body composition

Time Frame: 8 weeks, three measurements: at week 0, 4 and 8

Body composition will include percent body fat and lean body mass measured with air displacement plethysmography

Waist and hips circumference

Time Frame: 8 weeks, three measurements: at week 0, 4 and 8

Measured in cm

Secondary Outcomes

  • Liver function test(8 weeks, two measurements: at week 0 and 8)
  • Dietary intake(8 weeks, two measurements: at week 0 and 8)
  • sex hormones(8 weeks, two measurements: at week 0 and 8)

Study Sites (1)

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