The Impact of Betaine Supplementation on Body Composition and Lipid Metabolism in a Group of Overweight and Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Lipid profile
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age: 18-45 years
- •pre-menopausal
- •overweight or obese: BMI >25 kg/m2
- •waist circumference > 80 cm
排除标准
- •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
结局指标
主要结局
Lipid profile
时间窗: 8 weeks, two measurements: at week 0 and 8
Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol
Body mass
时间窗: 8 weeks, three measurements: at week 0, 4 and 8
Measured in kg
Gene expression
时间窗: 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
时间窗: 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
时间窗: 8 weeks, three measurements: at week 0, 4 and 8
Measured in cm
次要结局
- Dietary intake(8 weeks, two measurements: at week 0 and 8)
- sex hormones(8 weeks, two measurements: at week 0 and 8)
- Liver function test(8 weeks, two measurements: at week 0 and 8)
- 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)
研究者
Agata Chmurzyńska
Professor
Poznan University of Life Sciences