Clinical trial NCT04728399: Soy Peptide, Conjugated Linoleic Acid, Overweight or Obese, Body Composition
Official title: Effects of Soy Peptide and Conjugated Linoleic Acid on Body Composition: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight or Obesity
Keywords: Soy Peptide
Conjugated Linoleic Acid
Overweight or Obesity
Body Composition
Fatty liver disease
RCT
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2021-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver fat content
timeFrame: Baseline & 24weeks
measure: Fat and thin tissue
timeFrame: Baseline & 12 weeks & 24weeks
measure: Adipocytokine
timeFrame: Baseline & 24weeks
measure: Inflammatory factor index
timeFrame: Baseline & 24weeks
measure: Blood fat
timeFrame: Baseline & 12 weeks & 24weeks
Secondary outcomes:
measure: Liver function
timeFrame: Baseline & 12 weeks & 24weeks
measure: Food recording
timeFrame: Baseline & 12 weeks & 24weeks
measure: Wechat steps
timeFrame: Baseline & 12 weeks & 24weeks
measure: Sitting time
timeFrame: Baseline & 12 weeks & 24weeks
measure: Regular sport recording
timeFrame: Baseline & 12 weeks & 24weeks
measure: Kidney function
timeFrame: Baseline & 12 weeks & 24weeks
Other outcomes:
measure: Anxiety situation
timeFrame: Baseline & 12 weeks & 24weeks
measure: Adverse reactions or side effects
timeFrame: Baseline & 12 weeks & 24weeks
measure: Compliance assessment
timeFrame: 12 weeks & 24weeks
Locations:
city: Guangzhou
country: China
facility: Jinan University
state: Guangdong
Study officials:
References:
citation: Derakhshande-Rishehri SM, Mansourian M, Kelishadi R, Heidari-Beni M. Association of foods enriched in conjugated linoleic acid (CLA) and CLA supplements with lipid profile in human studies: a systematic review and meta-analysis. Public Health Nutr. 2015 Aug;18(11):2041-54. doi: 10.1017/S1368980014002262. Epub 2014 Nov 7.
citation: Bruen R, Fitzsimons S, Belton O. Atheroprotective effects of conjugated linoleic acid. Br J Clin Pharmacol. 2017 Jan;83(1):46-53. doi: 10.1111/bcp.12948. Epub 2016 May 7.
citation: den Hartigh LJ. Conjugated Linoleic Acid Effects on Cancer, Obesity, and Atherosclerosis: A Review of Pre-Clinical and Human Trials with Current Perspectives. Nutrients. 2019 Feb 11;11(2):370. doi: 10.3390/nu11020370.
citation: Whigham LD, Watras AC, Schoeller DA. Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr. 2007 May;85(5):1203-11. doi: 10.1093/ajcn/85.5.1203.
citation: Fuke G, Nornberg JL. Systematic evaluation on the effectiveness of conjugated linoleic acid in human health. Crit Rev Food Sci Nutr. 2017 Jan 2;57(1):1-7. doi: 10.1080/10408398.2012.716800.