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

Last updated: January 11, 2010
Sponsor: University of Manitoba
Overall Status: Completed

Phase

1

Condition

Inflammation

Hypercholesterolemia

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01047280
B2005:183
  • Ages 18-60
  • Male
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. The CLA will be supplemented in an oil form and will be added to solid foods as provided by the metabolic kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

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

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

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

  5. subjects who have any major food allergies or are vegetarian;

  6. subjects that use natural or pharmaceutical weight loss supplements or products knownto affect lipid metabolism at the beginning and end of each treatment period as wellas the washout periods;

  7. subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed,marigolds, daisies).

Study Design

Total Participants: 36
Study Start date:
November 01, 2006
Estimated Completion Date:
May 31, 2009

Study Description

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.