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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

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.

Condition or disease Intervention/treatment Phase
Obesity Adiposity Dietary Supplement: Conjugated linoleic acid group Dietary Supplement: Sunflower oil group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
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
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
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : June 21, 2019
Estimated Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Change of body fat percentage [ Time Frame: week 0 and week 12 ]

Secondary Outcome Measures :
  1. Change of body fat mass [ Time Frame: week 0 and week 12 ]
  2. Change of body mass index [ Time Frame: week 0 and week 12 ]
  3. Change of weight [ Time Frame: week 0, week 4, week 8, and week 12 ]
  4. Change of waist circumference [ Time Frame: week 0 and week 12 ]
  5. Change of triglycerides [ Time Frame: week 0 and week 12 ]
  6. Change of total cholesterol [ Time Frame: week 0 and week 12 ]
  7. Change of LDL-cholesterol [ Time Frame: week 0 and week 12 ]
  8. Change of HDL-cholesterol [ Time Frame: week 0 and week 12 ]
  9. Change of blood pressure [ Time Frame: week 0 and week 12 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915808


Locations
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China, Shaanxi
Xi'an Jiaotong University Health Science Center
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
Jiaomei Yang
Investigators
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Principal Investigator: Xin Liu, PhD Xi'an Jiaotong University Health Science Center

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Responsible Party: Jiaomei Yang, Associate Research Fellow, Health Science Center of Xi’an Jiaotong University
ClinicalTrials.gov Identifier: NCT03915808     History of Changes
Other Study ID Numbers: 20190201
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms