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

Overweight or Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04728399
• Other study ID #: JNUKY-2020-002
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: June 2021
• Source: Jinan University Guangzhou
• Contact: Fangfang Zeng
• Phone: +86 138222285635
• Email: zengffjnu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Dietary Supplement:
• Experimental group
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
• Control group
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

Locations

Country	Name	City	State
China	Jinan University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fangfang Zeng	First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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). pii: E370. doi: 10.3390/nu11020370. Review. — View 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 A — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety situation	SAS scale will be used to reflect the subject's mood.Generally speaking, the total score of anxiety is less than 50 points for normal;50 to 60 people have mild anxiety, 61 to 70 people have moderate anxiety, and 70 or more people have severe anxiety.	Baseline & 12 weeks & 24weeks
Other	Adverse reactions or side effects	) Patients were questioned by investigators at baseline, 12 weeks and 24 weeks respectively. If there is any suspicious incident, it will be reported by the investigator first, and then reviewed by the doctor or the project leader and recorded in time.	Baseline & 12 weeks & 24weeks
Other	Compliance assessment	Compliance was assessed at week 12 and 14 using the MMAS-8 questionnaire. There are 8 items in total. For questions 1-4 and 6-7, if you choose "no", you will get 1 point; for question 5, if you choose "yes", you will get 1 point; for other options, you will get 0 point; for question 8, if you choose "never, rarely, sometimes, often", you will get 1 point, 0.75 point, 0.5 point, 0.25 point and 0 point respectively. Less than 6 points indicated poor compliance, 6-8 points indicated medium compliance, and 8 points indicated good compliance.	12 weeks & 24weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Wechat steps	Record the 3-day wechat steps in kilograms to assess basic movement situation.	Baseline & 12 weeks & 24weeks
Secondary	Sitting time	Record the 3-day sitting time in hours to evaluate the sedentary situation of subjects every day.	Baseline & 12 weeks & 24weeks
Secondary	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
Secondary	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