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

NCT04728399 | Unknown DMC

• 1 other identifier: JNUKY-2020-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight or Obesity

Keywords

Soy Peptide; Conjugated Linoleic Acid; Overweight or Obesity; Body Composition; Fatty liver disease; RCT

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Liver function

  Baseline & 12 weeks & 24weeks

• Food recording

  Baseline & 12 weeks & 24weeks

• Wechat steps

  Baseline & 12 weeks & 24weeks

• Sitting time

  Baseline & 12 weeks & 24weeks

• Regular sport recording

  Baseline & 12 weeks & 24weeks

Other Outcomes (3)

• Anxiety situation

  Baseline & 12 weeks & 24weeks

• Adverse reactions or side effects

  Baseline & 12 weeks & 24weeks

• Compliance assessment

  12 weeks & 24weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Experimental group

Control group

PLACEBO COMPARATOR

2g+N protein and 3g Soybean oil.

Dietary Supplement: Control group

Interventions

Experimental group DIETARY_SUPPLEMENT

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

Also known as: Soybean peptide and CLA

Experimental group

Control group DIETARY_SUPPLEMENT

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

Also known as: Protein and Soybean oil

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fangfang Zeng: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Jinan University

Guangzhou, Guangdong, 457, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 25379623 RESULT

• 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.

  PMID: 27037767 RESULT

• 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.

  PMID: 30754681 RESULT

• 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.

  PMID: 17490954 RESULT

• 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.

  PMID: 27636835 RESULT

MeSH Terms

Conditions

Overweight; Obesity; Non-alcoholic Fatty Liver Disease

Interventions

Control Groups; Proteins; Soybean Oil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Amino Acids, Peptides, and Proteins; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Fangfang Zeng

CONTACT

+86 138222285635; zengffjnu@126.com

Sixian Tab

CONTACT

18873980199; tansixianjnu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, School of basic medicine and public health

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 28, 2021
• Study Start: May 14, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

CN (1)