Effects of Soy Peptide and Conjugated Linoleic Acid on Body Composition: a Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Liver fat content
研究概览
简要总结
Soybean peptides are a mixture of active peptides obtained from the hydrolysis of soybean protein, which have biological activities such as antioxidant, blood pressure lowering, anti-fatigue and lipid lowering, etc. They can regulate food intake, increase satiety, and reduce fat body ratio by reducing cholesterol and triglyceride content and stimulating CCK secretion.Conjugated linoleic acid (CLA) is a set of linoleic acid with conjugated unsaturated double bond, the location and structure of the isomers have been approved by the ministry of health in China as a new resource food , widely used in areas such as health care products, functional foods and food additives, animal experiments showed that it has reduce tumor, atherosclerosis, obesity risk.Therefore, in this study, the effect of conjugated linoleic acid combined with soybean peptide on overweight and obese people was investigated in a randomized controlled manner.
详细描述
Aim 1: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on body fat, liver fat and muscle content of overweight and obese people;Aim 2: To test the effects of combined supplementation of soybean peptide and conjugated linoleic acid on blood lipid, blood glucose, fat or inflammatory factors in overweight and obese people; Aim 3: Test the impact of the above interventions on safety indicators (safety indicators: liver and kidney function, self-reported adverse reactions or diseases). Aim 4: To provide scientific basis for the development of functional food for weight loss and muscle gain.The public health significance of this research is that find a new functional food for weight loss and muscle gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - 18-65 years old;
- •Gender-not limited;
- •BMI-24-35 kg/m2;
- •Body fat rate-Male ≥25%, female ≥30% (body fat meter can be used for screening, DXA is used for diagnosis);
- •Waist circumference: male >90cm, Female>80cm (not required).
排除标准
- •Suffer from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors;
- •Take drugs or supplements that have a known effect on body fat and muscle mass;
- •Those whose weight has changed more than 10% in the past 3 months;
- •Those who have cognitive or mental disorders and cannot conduct questionnaire surveys;
- •People who are physically disabled and cannot walk normally;
- •Those whose compliance with the pre-experiment period cannot meet the requirements;
- •Fail to sign the informed consent form, or other researchers think it is not suitable for participants
结局指标
主要结局
Liver fat content
时间窗: Baseline & 24weeks
Liver fat content will be measured by magnetic resonance (MR) which will be evaluated for change over the course of liver fat content. Baseline: Evaluate the initial fat content of the subjects; 24weeks: Evaluate whether the fat content of the subjects changes after the intervention.
Blood fat
时间窗: Baseline & 12 weeks & 24weeks
Blood fat inde(such as TG, TC) will be detected by biochemical examination. Baseline: assess the physical condition of subjects to determine whether they meet the criteria for inclusion; 12 weeks: Evaluate the levels of TG, TC after three-months intervention, If there is a significant increase in Blood fat, the experiment should be stopped in time; 24 weeks: Evaluate the effect of lowering blood lipid of the subjects.
Inflammatory factor index
时间窗: Baseline & 24weeks
Inflammatory factor index will be detected by biochemical experiments to reveal the possible pathways of action of soybean peptides and conjugated linoleic acid. Baseline: Evaluate the levels of inflammatory factors (such CRP, IL-6) before intervention; 24weeks: Evaluate the levels of inflammatory factors after intervention, If the levels of inflammatory factors change, it suggests that soy peptides and conjugated acid oil may achieve weight loss through inflammatory pathway.
Fat and thin tissue
时间窗: Baseline & 12 weeks & 24weeks
Body fat percentage will be screened with DXA apparatus.Assess the patient's physical condition. Baseline: Evaluate the body composition of the subjects to see whether they meet the inclusion criteria; 12 weeks: After 3 months of intervention, If the percentage of fat is lower than the baseline, the body composition is improved, if the proportion of fat increased by more than 5%, the test should be stopped in time. 24 weeks: Evaluate the improvement of body composition before and after the intervention. If the percentage of fat is lower than the baseline, the body composition is improved. Baseline: Evaluate the body composition of the subjects to see whether they meet the inclusion criteria; 12 weeks: After 3 months of intervention, the subjects will be evaluated for weight improvement.If the proportion of fat; 24 weeks: Evaluate the improvement of body composition before and after the intervention.
Adipocytokine
时间窗: Baseline & 24weeks
Adipocytokines will be detected by biochemical experiments to reveal the possible pathways of action of soybean peptides and conjugated linoleic acid. Baseline: Evaluate the levels of adipocytokines (such as leptin and adiponectin) before intervention; 24 weeks: Evaluate the levels of adipocytokines (such as leptin and adiponectin) after intervention, If the serum leptin and adiponectin levels change, it can provide a new idea for the combined weight loss mechanism of soybean peptide and conjugated linoleic acid.
次要结局
- Wechat steps(Baseline & 12 weeks & 24weeks)
- Kidney function(Baseline & 12 weeks & 24weeks)
- Regular sport recording(Baseline & 12 weeks & 24weeks)
- Liver function(Baseline & 12 weeks & 24weeks)
- Food recording(Baseline & 12 weeks & 24weeks)
- Sitting time(Baseline & 12 weeks & 24weeks)
研究者
Fangfang Zeng
Associate Professor, School of basic medicine and public health
Jinan University Guangzhou