Poznan University of Life Sciences
Poznan, 60-637, Poland
NCT Number: NCT06344377
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Poznan, 60-637, Poland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Betaine supplemented for 8 weeks
Placebo supplementation for 8 weeks
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
Time frame: 8 weeks, three measurements: at week 0, 4 and 8
Measured in kg
Time frame: 8 weeks, three measurements: at week 0, 4 and 8
Measured in cm
Time frame: 8 weeks, two measurements: at week 0 and 8
Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol
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
Time frame: 8 weeks, two measurements: at week 0 and 8
activities of enzymes: ALT, AST, GGTP, ALP
Time frame: 8 weeks, two measurements: at week 0 and 8
Based on food diary
Time frame: 8 weeks, two measurements: at week 0 and 8
Poznan University of Life Sciences
Other
The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women
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