Completed

CLAUse of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

What is being tested

Clarinol G-80 ® treatment

+ Safflower oil

+ G-c9, t11

Dietary Supplement

Who is being recruted

Body Weight+7

+ Hyperlipidemias

+ Inflammation

From 18 to 60 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: November 2006

See protocol details

Summary

Principal SponsorUniversity of Manitoba

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2006

Actual date on which the first participant was enrolled.

In order to investigate the effectiveness of CLA on body weight and composition, as well as blood lipids, a double-blinded, 3-phase crossover trial will be conducted in moderately overweight (BMI=25-40 kg/m2), borderline hypercholesterolemic (LDL-C ≥ 2.5 mmol/L) men between the ages of 18-60 years. During three 8-week phases separated by 4-week washout periods, and under supervision to ensure compliance, 28 subjects will consume in random order (i) Control: 3.5 g/d of safflower oil, (ii) Clarinol G-80®: 3.5 g/d of 50:50 mixture of t10, c12 and c9, t11 CLA and (iii) c9, t11: 3.5 g/day of c9, t11 CLA. Body weight, fat mass and lean body mass will be measured at beginning and end of each phase by dual energy X-ray absorptiometry (DEXA). Baseline and endpoint blood samples will collected to determine blood lipid profile, and different safety parameters, including insulin sensitivity (HOMA-IR index), and concentrations of inflammatory (hs-CRP, TNF-α, IL-6) and oxidative (Oxidized-LDL) biomarkers. Effect of CLA consumption on fatty acid oxidation will also be measured.

Official TitleUse of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

NCT01047280

Principal SponsorUniversity of Manitoba

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightHyperlipidemiasInflammationMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism Disorders

Criteria

1 inclusion criteria required to participate

Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study.

7 exclusion criteria prevent from participating

subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study;

subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;

subjects who currently have diabetes, kidney, heart or liver disease or have had any of these diseases at any time during the past 3 months. In addition any development of diabetes mellitus, kidney, heart or liver disease during the trial will lead to exclusion from the trial;

subjects who smoke or consume large amounts of alcohol (> 2 drinks/day);

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

This arm of the study constitutes the control phase

Group III

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

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CompletedNo study centers