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

Not Applicable

Completed

• Conditions: Obesity; Adiposity
• Interventions: Dietary Supplement: Conjugated linoleic acid group; Dietary Supplement: Sunflower oil group

• Registration Number: NCT03915808
• Lead Sponsor: Jiaomei Yang

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.

Study Timeline

• Study Start: 2019-03-27
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-13
• Study First Posted: 2019-04-16
• Primary Completion: 2019-06-21
• Study Completion: 2019-07-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-27
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conjugated linoleic acid plus lifestyle counselling	Conjugated linoleic acid group	supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly
Sunflower oil plus lifestyle counselling	Sunflower oil group	supplementation of equivalent sunflower oil, and receive education sessions regularly

Primary Outcome Measures

Name	Time	Method
Change of body fat percentage	week 0 and week 12

Secondary Outcome Measures

Name	Time	Method
Change of body fat mass	week 0 and week 12
Change of body mass index	week 0 and week 12
Change of waist circumference	week 0 and week 12
Change of blood pressure	week 0 and week 12
Change of weight	week 0, week 4, week 8, and week 12
Change of triglycerides	week 0 and week 12
Change of LDL-cholesterol	week 0 and week 12
Change of total cholesterol	week 0 and week 12
Change of HDL-cholesterol	week 0 and week 12

Trial Locations

Locations (1)

Xi'an Jiaotong University Health Science Center; 🇨🇳 Xi'an, Shaanxi, China