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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915808
• Other study ID #: 20190201
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: July 21, 2019

Study information

• Verified date: February 2020
• Source: Health Science Center of Xi’an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Obesity

Intervention

Dietary Supplement:
• 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)
• 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)

Locations

Country	Name	City	State
China	Xi'an Jiaotong University Health Science Center	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiaomei Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body fat percentage		week 0 and week 12
Secondary	Change of body fat mass		week 0 and week 12
Secondary	Change of body mass index		week 0 and week 12
Secondary	Change of weight		week 0, week 4, week 8, and week 12
Secondary	Change of waist circumference		week 0 and week 12
Secondary	Change of triglycerides		week 0 and week 12
Secondary	Change of total cholesterol		week 0 and week 12
Secondary	Change of LDL-cholesterol		week 0 and week 12
Secondary	Change of HDL-cholesterol		week 0 and week 12
Secondary	Change of blood pressure		week 0 and week 12