Overweight and Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBetaine
Betaine supplemented for 8 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo supplementation for 8 weeks
Sponsors
Poznan University of Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 mass | 8 weeks, three measurements: at week 0, 4 and 8 | Measured in kg |
| Waist and hips circumference | 8 weeks, three measurements: at week 0, 4 and 8 | Measured in cm |
| Lipid profile | 8 weeks, two measurements: at week 0 and 8 | Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary intake | 8 weeks, two measurements: at week 0 and 8 | Based on food diary |
| sex hormones | 8 weeks, two measurements: at week 0 and 8 | — |
| Liver function test | 8 weeks, two measurements: at week 0 and 8 | activities of enzymes: ALT, AST, GGTP, ALP |
Countries
Poland
Outcome results
None listed