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

Primary Purpose

Overweight or Obesity

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental group
Control group
Sponsored by
Fangfang Zeng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight or Obesity focused on measuring Soy Peptide, Conjugated Linoleic Acid, Overweight or Obesity, Body Composition, Fatty liver disease, RCT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

2g Soybean peptide, 3g CLA and ng protein.

2g+N protein and 3g Soybean oil.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
Wechat steps
Record the 3-day wechat steps in kilograms to assess basic movement situation.
Sitting time
Record the 3-day sitting time in hours to evaluate the sedentary situation of subjects every day.
Regular sport recording
Record the 3-day regular movement, including the name and duration of movements on that day.（e.g., swimming, two hours）
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.

Full Information

First Posted
January 15, 2021
Last Updated
June 12, 2021
Sponsor
Fangfang Zeng
Collaborators
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04728399
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fangfang Zeng
Collaborators
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Soy Peptide, Conjugated Linoleic Acid, Overweight or Obesity, Body Composition, Fatty liver disease, RCT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
2g Soybean peptide, 3g CLA and ng protein.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
2g+N protein and 3g Soybean oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental group
Other Intervention Name(s)
Soybean peptide and CLA
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Other Intervention Name(s)
Protein and Soybean oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Liver fat content
Description
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.
Time Frame
Baseline & 24weeks
Title
Fat and thin tissue
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Adipocytokine
Description
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.
Time Frame
Baseline & 24weeks
Title
Inflammatory factor index
Description
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.
Time Frame
Baseline & 24weeks
Title
Blood fat
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Secondary Outcome Measure Information:
Title
Liver function
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Food recording
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Wechat steps
Description
Record the 3-day wechat steps in kilograms to assess basic movement situation.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Sitting time
Description
Record the 3-day sitting time in hours to evaluate the sedentary situation of subjects every day.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Regular sport recording
Description
Record the 3-day regular movement, including the name and duration of movements on that day.（e.g., swimming, two hours）
Time Frame
Baseline & 12 weeks & 24weeks
Title
Kidney function
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Other Pre-specified Outcome Measures:
Title
Anxiety situation
Description
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.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Adverse reactions or side effects
Description
) 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.
Time Frame
Baseline & 12 weeks & 24weeks
Title
Compliance assessment
Description
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.
Time Frame
12 weeks & 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fangfang Zeng
Phone
+86 138222285635
Email
zengffjnu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sixian Tab
Phone
18873980199
Email
tansixianjnu@163.com
Facility Information:
Facility Name
Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
457
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fangfang Zeng
Phone
+86 13822285635
Email
zengffjnu@126.com
First Name & Middle Initial & Last Name & Degree
Sixian Tan
Phone
+8618873980199
Email
tansixianjnu@163.com
First Name & Middle Initial & Last Name & Degree
Sixian Tan
First Name & Middle Initial & Last Name & Degree
Lu Zheng

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25379623
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.
Results Reference
result
PubMed Identifier
27037767
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.
Results Reference
result
PubMed Identifier
30754681
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.
Results Reference
result
PubMed Identifier
17490954
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.
Results Reference
result
PubMed Identifier
27636835
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.
Results Reference
result

Learn more about this trial

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

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