NCT03915808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

April 9, 2019

Last Update Submit

February 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of body fat percentage

    week 0 and week 12

Secondary Outcomes (9)

  • Change of body fat mass

    week 0 and week 12

  • Change of body mass index

    week 0 and week 12

  • Change of weight

    week 0, week 4, week 8, and week 12

  • Change of waist circumference

    week 0 and week 12

  • Change of triglycerides

    week 0 and week 12

  • +4 more secondary outcomes

Study Arms (2)

Conjugated linoleic acid plus lifestyle counselling

EXPERIMENTAL

supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly

Dietary Supplement: Conjugated linoleic acid group

Sunflower oil plus lifestyle counselling

PLACEBO COMPARATOR

supplementation of equivalent sunflower oil, and receive education sessions regularly

Dietary Supplement: Sunflower oil group

Interventions

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)

Conjugated linoleic acid plus lifestyle counselling
Sunflower oil groupDIETARY_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)

Sunflower oil plus lifestyle counselling

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xi'an Jiaotong University Health Science Center

Xi'an, Shaanxi, 710061, China

Location

Related Publications (3)

  • Jia K, She Y, He Y, He J, He Y, Xu K, Ma G, Li W, He C, Feng X, Wang M, Tang A, Sun X, Kong L, Liu X. Conjugated Linoleic Acid Supplementation Suppresses the De Novo Lipogenesis in Adults With High Body Fat: A Double-Blind, Randomized, Placebo-Controlled Trial. Mol Nutr Food Res. 2025 Dec;69(24):e70306. doi: 10.1002/mnfr.70306. Epub 2025 Oct 30.

  • He Y, Xu K, Li Y, Chang H, Liao X, Yu H, Tian T, Li C, Shen Y, Wu Q, Liu X, Shi L. Metabolomic Changes Upon Conjugated Linoleic Acid Supplementation and Predictions of Body Composition Responsiveness. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2606-2615. doi: 10.1210/clinem/dgac367.

  • Chang H, Gan W, Liao X, Wei J, Lu M, Chen H, Wang S, Ma Y, Wu Q, Yu Y, Liu X. Conjugated linoleic acid supplements preserve muscle in high-body-fat adults: A double-blind, randomized, placebo trial. Nutr Metab Cardiovasc Dis. 2020 Sep 24;30(10):1777-1784. doi: 10.1016/j.numecd.2020.05.029. Epub 2020 Jun 8.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xin Liu, PhD

    Xi'an Jiaotong University Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Research Fellow

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 16, 2019

Study Start

March 27, 2019

Primary Completion

June 21, 2019

Study Completion

July 21, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations