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

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01047280
First received: January 8, 2010
Last updated: January 11, 2010
Last verified: December 2009
  Purpose

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).


Condition Intervention Phase
Body Weight
Body Composition
Hyperlipidemia
Inflammation
Oxidative Stress
Dietary Supplement: Clarinol G-80 ® treatment
Dietary Supplement: Safflower oil
Dietary Supplement: G-c9, t11
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Use of Conjugated Linoleic Acid as a Nutraceutical for Weight Loss in Humans

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Changes in body weight, body fat mass, and lean body mass [ Time Frame: At baseline and endpoint of each phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in inflammation and oxidation markers [ Time Frame: At baseline and endpoint of each phase ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: November 2006
Study Completion Date: May 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047280

Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Peter JH Jones, Ph.D. University of Manitoba
  More Information

No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter J Jones, PhD, Richardson Centre for Functional Foods and Nutraceuticals
ClinicalTrials.gov Identifier: NCT01047280     History of Changes
Other Study ID Numbers: B2005:183
Study First Received: January 8, 2010
Last Updated: January 11, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Conjugated linoleic acid
Body weight
Body composition
Blood lipid profile
Body inflammatory and oxidative status

Additional relevant MeSH terms:
Body Weight
Hyperlipidemias
Inflammation
Weight Loss
Signs and Symptoms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Body Weight Changes

ClinicalTrials.gov processed this record on July 28, 2014