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

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ClinicalTrials.gov Identifier: NCT04728399
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : June 16, 2021
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Fangfang Zeng, Jinan University Guangzhou

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overweight or Obesity Dietary Supplement: Experimental group Dietary Supplement: Control group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Soy Peptide and Conjugated Linoleic Acid on Body Composition: a Double-blind, Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date : May 14, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Protein and Soybean oil


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. Wechat steps [ Time Frame: Baseline & 12 weeks & 24weeks ]
    Record the 3-day wechat steps in kilograms to assess basic movement situation.

  4. 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.

  5. 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）

  6. 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.



Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728399


Contacts
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Contact: Fangfang Zeng +86 138222285635 zengffjnu@126.com
Contact: Sixian Tab 18873980199 tansixianjnu@163.com

Locations
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China, Guangdong
Jinan University Recruiting
Guangzhou, Guangdong, China, 457
Contact: Fangfang Zeng    +86 13822285635    zengffjnu@126.com   
Contact: Sixian Tan    +8618873980199    tansixianjnu@163.com   
Principal Investigator: Sixian Tan         
Sub-Investigator: Lu Zheng         
Sponsors and Collaborators
Fangfang Zeng
First Affiliated Hospital, Sun Yat-Sen University
More Information
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Publications of Results:

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Responsible Party: Fangfang Zeng, Associate Professor, School of basic medicine and public health, Jinan University Guangzhou
ClinicalTrials.gov Identifier: NCT04728399    
Other Study ID Numbers: JNUKY-2020-002
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fangfang Zeng, Jinan University Guangzhou:
Soy Peptide
Conjugated Linoleic Acid
Overweight or Obesity
 Body Composition
Fatty liver disease
RCT
Additional relevant MeSH terms:
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Overweight
Body Weight