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

January 11, 2010 updated by: University of Manitoba
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 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.

Exclusion Criteria:

  1. 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;
  2. subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;
  3. 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;
  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 known to affect lipid metabolism at the beginning and end of each treatment period as well as the washout periods;
  7. subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed, marigolds, daisies).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Safflower oil
This arm of the study constitutes the control phase
Dietary supplement: Safflower oil
3.5 g/d of safflower oil
Experimental: Clarinol G-80®
Dietary supplement: Clarinol G-80 ® treatment
dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).
Experimental: G-c9, t11
Dietary supplement: G-c9, t11
3.5 g/day of c9, t11 CLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in body weight, body fat mass, and lean body mass
Time Frame: At baseline and endpoint of each phase
At baseline and endpoint of each phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in inflammation and oxidation markers
Time Frame: At baseline and endpoint of each phase
At baseline and endpoint of each phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Peter JH Jones, Ph.D., University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2005:183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Safflower oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe