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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betaine | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betaine | Dietary Supplement | Betaine supplemented for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Body mass | Measured in kg | 8 weeks, three measurements: at week 0, 4 and 8 |
| Waist and hips circumference | Measured in cm | 8 weeks, three measurements: at week 0, 4 and 8 |
| Lipid profile | Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol | 8 weeks, two measurements: at week 0 and 8 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function test | activities of enzymes: ALT, AST, GGTP, ALP | 8 weeks, two measurements: at week 0 and 8 |
| Dietary intake | Based on food diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agata Chumrzynska | Poznan University of Life Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Life Sciences | Poznan | 60-637 | Poland |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D001622 | Betaine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Dietary Supplement |
Placebo supplementation for 8 weeks |
|
| 8 weeks, two measurements: at week 0 and 8 |
| sex hormones | 8 weeks, two measurements: at week 0 and 8 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009861 |
| Onium Compounds |