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

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ClinicalTrials.gov Identifier: NCT03915808
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jiaomei Yang, Health Science Center of Xi’an Jiaotong University

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
Change of body fat percentage [ Time Frame: week 0 and week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • Change of body fat mass [ Time Frame: week 0 and week 12 ]
  • Change of body mass index [ Time Frame: week 0 and week 12 ]
  • Change of weight [ Time Frame: week 0, week 4, week 8, and week 12 ]
  • Change of waist circumference [ Time Frame: week 0 and week 12 ]
  • Change of triglycerides [ Time Frame: week 0 and week 12 ]
  • Change of total cholesterol [ Time Frame: week 0 and week 12 ]
  • Change of LDL-cholesterol [ Time Frame: week 0 and week 12 ]
  • Change of HDL-cholesterol [ Time Frame: week 0 and week 12 ]
  • Change of blood pressure [ Time Frame: week 0 and week 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Supplementation of Conjugated Linoleic Acid on Body Fat Reduction
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Adiposity
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: Conjugated linoleic acid plus lifestyle counselling
    supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly
    Intervention: Dietary Supplement: Conjugated linoleic acid group
  • Placebo Comparator: Sunflower oil plus lifestyle counselling
    supplementation of equivalent sunflower oil, and receive education sessions regularly
    Intervention: Dietary Supplement: Sunflower oil group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 13, 2019)
66
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 21, 2019
Estimated Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03915808
Other Study ID Numbers  ICMJE 20190201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiaomei Yang, Health Science Center of Xi’an Jiaotong University
Study Sponsor  ICMJE Jiaomei Yang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xin Liu, PhD Xi'an Jiaotong University Health Science Center
PRS Account Health Science Center of Xi’an Jiaotong University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP