Clinical trial NCT03915808: The Effects of Supplementation of Conjugated Linoleic Acid on Body Fat Reduction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Adiposity
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of body fat percentage
timeFrame: week 0 and week 12
Secondary outcomes:
measure: Change of body fat mass
timeFrame: week 0 and week 12
measure: Change of body mass index
timeFrame: week 0 and week 12
measure: Change of weight
timeFrame: week 0, week 4, week 8, and week 12
measure: Change of waist circumference
timeFrame: week 0 and week 12
measure: Change of triglycerides
timeFrame: week 0 and week 12
measure: Change of total cholesterol
timeFrame: week 0 and week 12
measure: Change of LDL-cholesterol
timeFrame: week 0 and week 12
measure: Change of HDL-cholesterol
timeFrame: week 0 and week 12
measure: Change of blood pressure
timeFrame: week 0 and week 12
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an Jiaotong University Health Science Center
state: Shaanxi
Study officials:
affiliation: Xi'an Jiaotong University Health Science Center
name: Xin Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.