ObesityNCT03915808

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

A study testing Conjugated linoleic acid group and Sunflower oil group in people with Obesity and Adiposity, run by Jiaomei Yang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Obesity, Adiposity
What is being tested?: Conjugated linoleic acid group and Sunflower oil group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteChina
Study dates: 27 Mar 2019to 21 Jul 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Read the 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.

Conditions: Obesity, Adiposity
Being tested: Conjugated linoleic acid group, Sunflower oil group
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conjugated linoleic acid groupDietary 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 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)

Study groups in NCT03915808
Study group	Role	What they receive
Conjugated linoleic acid plus lifestyle counselling	Experimental	supplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly Receives: Dietary Supplement: Conjugated linoleic acid group
Sunflower oil plus lifestyle counselling	Placebo comparator	supplementation of equivalent sunflower oil, and receive education sessions regularly Receives: Dietary Supplement: Sunflower oil group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of body fat percentage
Measured: week 0 and week 12

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201921 Jul 2019

First posted16 Apr 2019
Study start27 Mar 2019
Primary completion21 Jun 2019
Study completion21 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03915808
Sponsor's protocol ID: 20190201
Status last verified: Feb 2020
First submitted: 9 Apr 2019
Last updated: 28 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 41169023
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.
PubMed 35704027
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.
PubMed 32684362

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03915808
Acronym / sponsor ID: 20190201
Conditions: Obesity, Adiposity
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Jiaomei YangUniversity, hospital or other
Study start: 27 Mar 2019 (actual)
Primary completion: 21 Jun 2019 (actual)
Study completion: 21 Jul 2019 (actual)
First posted: 16 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Conjugated linoleic acid plus lifestyle counselling	Experimental	Dietary Supplement: Conjugated linoleic acid groupsupplementation of 3.2 g/day conjugated linoleic acid and receive education sessions regularly
Sunflower oil plus lifestyle counselling	Placebo comparator	Dietary Supplement: Sunflower oil groupsupplementation of equivalent sunflower oil, and receive education sessions regularly

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Conjugated linoleic acid groupsupplementation 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	Conjugated linoleic acid plus lifestyle counselling
Sunflower oil groupsupplementation 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)	Dietary supplement	Sunflower oil plus lifestyle counselling

Primary outcome

Change of body fat percentage
Time frame: week 0 and week 12

9 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Derived from this study: PubMed 41169023Jia 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.
Derived from this study: PubMed 35704027He 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.
Derived from this study: PubMed 32684362Chang 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.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
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Recruiting
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xin Liu, PhD principal investigator

Xi'an Jiaotong University Health Science Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Conjugated linoleic acid group and Sunflower oil group in people with Obesity and Adiposity, run by Jiaomei Yang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of body fat percentage (time frame: week 0 and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915808, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.