The Effects of Supplementation of Conjugated Linoleic Acid on Body Fat Reduction

NCT ID: NCT03915808

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2019-07-21

Brief Summary

This is a double-blinded randomized controlled trial, to evaluate the effectiveness of daily supplementation of 3.2 g CLA on body fat reduction and lipid profile in overweight or obese Chinese adults, during a lifestyle counselling-based weight loss.

Detailed Description

This will be a parallel randomized, double-blinded, placebo-controlled trial. Sixty-six overweight or obese men and women aged from 18 to 45 years with elevated body fat percentage, who also meet our inclusion and exclusion criteria, will be randomly assigned to: the treatment group, daily supplementation of 3.2 g CLA (Cis-9, trans-11 isomers and trans-10, cis-12 isomers) plus lifestyle counselling weight loss program; or the control group, daily supplementation of sunflower oil. The intervention will include a 3-day run-in phase and 12-week interventional phase. At baseline and the end of the intervention, physical examination including questionnaires, anthropometric measurement, body composition by Dual Energy X-ray Absorptiometry (DXA), biological sample collection will be undertaken. During the invention, regular lifestyle counselling sessions will be delivered, and detailed record will be tracked for all participants to monitor and improve the adherence and safety.

Conditions

Obesity; Adiposity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conjugated linoleic acid plus lifestyle counselling

supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly

Group Type: EXPERIMENTAL

Conjugated linoleic acid group

Intervention Type: DIETARY_SUPPLEMENT

supplementation of 3.2 g/day conjugated linoleic acid in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)

Sunflower oil plus lifestyle counselling

supplementation of equivalent sunflower oil, and receive education sessions regularly

Group Type: PLACEBO_COMPARATOR

Sunflower oil group

Intervention Type: DIETARY_SUPPLEMENT

supplementation of equivalent sunflower oil in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)

Interventions

Conjugated linoleic acid group

supplementation of 3.2 g/day conjugated linoleic acid in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)

Intervention Type: DIETARY_SUPPLEMENT

Sunflower oil group

supplementation of equivalent sunflower oil in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1) Body fat percentage ≥ 20% for men, Body fat percentage ≥ 30% for women ; 2) aged from 18 to 45 years old.

Exclusion Criteria

1. Pregnancy or lactation;

2. Abnormal liver or kidney function indicated by physical examination within 6 months;

3. Gastrointestinal problems that affect the complying with the procedure;

4. Sever cardiovascular disease;

5. Active cancer;

6. Mental diseases, epilepsy or using anti-depression drugs;

7. Using medicine that affect body weight;

8. Participating in other scientific studies within 3 months before the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiaomei Yang

OTHER

Sponsor Role: lead

Responsible Party

Jiaomei Yang

Associate Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University Health Science Center

Locations

Xi'an Jiaotong University Health Science Center

Xi'an, Shaanxi, China

Countries

China

References

He Y, Xu K, Li Y, Chang H, Liao X, Yu H, Tian T, Li C, Shen Y, Wu Q, Liu X, Shi L. Metabolomic Changes Upon Conjugated Linoleic Acid Supplementation and Predictions of Body Composition Responsiveness. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2606-2615. doi: 10.1210/clinem/dgac367.

Reference Type: DERIVED

PMID: 35704027 (View on PubMed)

Chang H, Gan W, Liao X, Wei J, Lu M, Chen H, Wang S, Ma Y, Wu Q, Yu Y, Liu X. Conjugated linoleic acid supplements preserve muscle in high-body-fat adults: A double-blind, randomized, placebo trial. Nutr Metab Cardiovasc Dis. 2020 Sep 24;30(10):1777-1784. doi: 10.1016/j.numecd.2020.05.029. Epub 2020 Jun 8.

Reference Type: DERIVED

PMID: 32684362 (View on PubMed)

Other Identifiers

20190201

Identifier Type: -

Identifier Source: org_study_id