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

NCT ID: NCT04728399

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Overweight or Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Experimental group

Intervention Type 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

Control group

2g+N protein and 3g Soybean oil.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Soybean peptide and CLA Protein and Soybean oil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Fangfang Zeng

OTHER

Sponsor Role lead

Responsible Party

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Fangfang Zeng

Associate Professor, School of basic medicine and public health

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jinan University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fangfang Zeng

Role: CONTACT

+86 138222285635

Sixian Tab

Role: CONTACT

18873980199

Facility Contacts

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Fangfang Zeng

Role: primary

+86 13822285635

Sixian Tan

Role: backup

+8618873980199

References

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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.

Reference Type RESULT
PMID: 25379623 (View on PubMed)

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.

Reference Type RESULT
PMID: 27037767 (View on PubMed)

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.

Reference Type RESULT
PMID: 30754681 (View on PubMed)

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.

Reference Type RESULT
PMID: 17490954 (View on PubMed)

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.

Reference Type RESULT
PMID: 27636835 (View on PubMed)

Other Identifiers

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JNUKY-2020-002

Identifier Type: -

Identifier Source: org_study_id

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