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

February 27, 2020 updated by: Jiaomei Yang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Xi'an Jiaotong University Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conjugated linoleic acid plus lifestyle counselling
supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly
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)
Placebo Comparator: Sunflower oil plus lifestyle counselling
supplementation of equivalent sunflower oil, and receive education sessions regularly
Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of body fat percentage
Time Frame: week 0 and week 12
week 0 and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiaomei Yang

Investigators

  • Principal Investigator: Xin Liu, PhD, Xi'an Jiaotong University Health Science Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2019

Primary Completion (Actual)

June 21, 2019

Study Completion (Actual)

July 21, 2019

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 13, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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