Soy Peptide, Conjugated Linoleic Acid, Overweight or Obese, Body Composition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Soy Peptide and Conjugated Linoleic Acid on Body Composition: a Double-blind, Randomized, Placebo-controlled Clinical Trial

Conditions
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Overweight or Obesity

Intervention / Treatment
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* Dietary Supplement: Experimental group
* Dietary Supplement: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>2g Soybean peptide, 3g CLA and ng protein. | Dietary Supplement: Experimental group<br>* Take 1 bag a day with warm boiling water. Intervention: 2g Soybean peptide, 3g CLA and ng protein. They will complete all baseline, 12-weeks, and 24-weeks visits<br>* Other names: Soybean peptide and CLA;|
| Placebo Comparator: Control group<br>2g+N protein and 3g Soybean oil. | Dietary Supplement: Control group<br>* Take 1 bag a day with warm boiling water. Intervention: 2g+N protein and 3g Soybean oil. They will complete all baseline, 12-weeks, and 24-weeks visits<br>* Other names: Protein and Soybean oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat content | 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. | Baseline & 24weeks | 
| Fat and thin tissue | 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. | Baseline & 12 weeks & 24weeks | 
| Adipocytokine | 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. | Baseline & 24weeks | 
| Inflammatory factor index | 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. | Baseline & 24weeks | 
| Blood fat | 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. | Baseline & 12 weeks & 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function | Liver function(such as AST, ALT) will be detected by biochemical examination.It is safety index to assess physical condition. Baseline: Assess whether the liver function of the subjects is normal; 12 weeks: After 3 months intervation, assess the change in liver function, If the liver function is damaged, the experiment should be terminated in time. 24 weeks: After intervation, assess the change in liver function. | Baseline & 12 weeks & 24weeks | 
| Food recording | 3-d dietary records will be used for food recording. Used to assess the subjects' other energy intake. The heading includes food type, cooking style and consumption amount. | Baseline & 12 weeks & 24weeks | 
| Wechat steps | Record the 3-day wechat steps in kilograms to assess basic movement situation. | Baseline & 12 weeks & 24weeks | 
| Sitting time | Record the 3-day sitting time in hours to evaluate the sedentary situation of subjects every day. | Baseline & 12 weeks & 24weeks | 
| Regular sport recording | Record the 3-day regular movement, including the name and duration of movements on that day.（e.g., swimming, two hours） | Baseline & 12 weeks & 24weeks | 
| Kidney function | Kidney function(such as Urea, creatinine) will be detected by biochemical examination.It is safety index to assess physical condition. Baseline: Assess whether the kidney function of the subjects is normal; 12 weeks: After 3 months intervation, assess the change in kidney function, If the kidney function is damaged, the experiment should be terminated in time. 24 weeks: After intervation, assess the change in kidney function. | Baseline & 12 weeks & 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Soy Peptide, Conjugated Linoleic Acid, Overweight or Obesity, Body Composition, Fatty liver disease