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Completed

NCT Number: NCT03915808

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xi'an Jiaotong University Health Science Center

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body fat percentage ≥ 20% for men, Body fat percentage ≥ 30% for women ; 2) aged from 18 to 45 years old.

Exclusion criteria

  • Pregnancy or lactation;
  • Abnormal liver or kidney function indicated by physical examination within 6 months;
  • Gastrointestinal problems that affect the complying with the procedure;
  • Sever cardiovascular disease;
  • Active cancer;
  • Mental diseases, epilepsy or using anti-depression drugs;
  • Using medicine that affect body weight;
  • Participating in other scientific studies within 3 months before the study.

Treatment and study plan

Conjugated linoleic acid group

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Change of body fat percentage

    Time frame: week 0 and week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jiaomei Yang

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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