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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03915808
Other study ID # 20190201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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