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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Supplementation of Conjugated Linoleic Acid on Body Fat Reduction in Overweight or Obesity Chinese Adults During Weight Loss: A Randomized, Double-blinded, Placebo-controlled Trial

Conditions
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Obesity, Adiposity

Intervention / Treatment
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* Dietary Supplement: Conjugated linoleic acid group
* Dietary Supplement: Sunflower oil group


Participation Criteria
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Eligibility Criteria
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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: Pregnancy or lactation; Abnormal liver or kidney function indicated by physical examination within 6 months; Gastrointestinal problems that affect the complying with the procedure; Sever cardiovascular disease; Active cancer; Mental diseases, epilepsy or using anti-depression drugs; Using medicine that affect body weight; Participating in other scientific studies within 3 months before the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a parallel randomized, double-blinded, placebo-controlled trial. Sixty-six overweight or obese men and women aged from 18 to 50 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conjugated linoleic acid plus lifestyle counselling<br>supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly | Dietary Supplement: Conjugated linoleic acid group<br>* 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)<br>|
| Placebo Comparator: Sunflower oil plus lifestyle counselling<br>supplementation of equivalent sunflower oil, and receive education sessions regularly | Dietary Supplement: Sunflower oil group<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body fat percentage |  | week 0 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of body fat mass |  | week 0 and week 12 | 
| Change of body mass index |  | week 0 and week 12 | 
| Change of weight |  | week 0, week 4, week 8, and week 12 | 
| Change of waist circumference |  | week 0 and week 12 | 
| Change of triglycerides |  | week 0 and week 12 | 
| Change of total cholesterol |  | week 0 and week 12 | 
| Change of LDL-cholesterol |  | week 0 and week 12 | 
| Change of HDL-cholesterol |  | week 0 and week 12 | 
| Change of blood pressure |  | week 0 and week 12 |