Adiposity, Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTConjugated 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)
DIETARY_SUPPLEMENTSunflower 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)
Sponsors
Jiaomei Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of body fat percentage | week 0 and week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 waist circumference | week 0 and week 12 |
| 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 blood pressure | week 0 and week 12 |
Countries
China
Outcome results
None listed