Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women
- Conditions
- Overweight and Obesity
- Interventions
- Dietary Supplement: BetaineDietary Supplement: Placebo
- Registration Number
- NCT06344377
- Lead Sponsor
- Poznan University of Life Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- females
- age: 18-45 years
- pre-menopausal
- overweight or obese: BMI >25 kg/m2
- waist circumference > 80 cm
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Betaine Betaine Betaine supplementation for 8 weeks, daily dose of 3 g/d, taken twice a day in a capsulated form. One capsule will contain 500 mg betaine. Daily number of capsules will be 2 x 3 = 6. Placebo Placebo Placebo will be inactive substance (maltodextrin) provided in the same-looking capsules as betaine. Placebo will be administered twice a day, daily number of capsules will be 2 x 3 = 6.
- Primary Outcome Measures
Name Time Method Lipid profile 8 weeks, two measurements: at week 0 and 8 Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol
Body mass 8 weeks, three measurements: at week 0, 4 and 8 Measured in kg
Gene expression 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 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 8 weeks, three measurements: at week 0, 4 and 8 Measured in cm
- Secondary Outcome Measures
Name Time Method Liver function test 8 weeks, two measurements: at week 0 and 8 concentraions of enzymes: ALT, AST, GGTP, ALP
Dietary intake 8 weeks, two measurements: at week 0 and 8 Based on food diary
Trial Locations
- Locations (1)
Poznan University of Life Sciences
🇵🇱Poznań, Poland