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

June 12, 2021 updated by: Fangfang Zeng

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 457
        • Recruiting
        • Jinan University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sixian Tan
        • Sub-Investigator:
          • Lu Zheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
2g Soybean peptide, 3g CLA and ng protein.
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
Other Names:
  • Soybean peptide and CLA
Placebo Comparator: Control group
2g+N protein and 3g Soybean oil.
Dietary supplement: 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
Other Names:
  • Protein and Soybean oil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function
Time Frame: Baseline & 12 weeks & 24weeks

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
Time Frame: Baseline & 12 weeks & 24weeks
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
Time Frame: Baseline & 12 weeks & 24weeks
Record the 3-day wechat steps in kilograms to assess basic movement situation.
Baseline & 12 weeks & 24weeks
Sitting time
Time Frame: Baseline & 12 weeks & 24weeks
Record the 3-day sitting time in hours to evaluate the sedentary situation of subjects every day.
Baseline & 12 weeks & 24weeks
Regular sport recording
Time Frame: Baseline & 12 weeks & 24weeks
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
Time Frame: Baseline & 12 weeks & 24weeks

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety situation
Time Frame: Baseline & 12 weeks & 24weeks
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
Adverse reactions or side effects
Time Frame: Baseline & 12 weeks & 24weeks
) 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
Compliance assessment
Time Frame: 12 weeks & 24weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fangfang Zeng

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2021

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

January 15, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 12, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JNUKY-2020-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight or Obesity

Clinical Trials on Experimental group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe