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

Inflammation Clinical Trial

— CLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047280
• Other study ID #: B2005:183
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: January 11, 2010
• Start date: November 2006
• Est. completion date: May 2009

Study information

• Verified date: December 2009
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Composition
• Body Weight
• Hyperlipidemia
• Hyperlipidemias
• Inflammation
• Oxidative Stress

Intervention

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%).
• Safflower oil
3.5 g/d of safflower oil
• G-c9, t11
3.5 g/day of c9, t11 CLA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body weight, body fat mass, and lean body mass		At baseline and endpoint of each phase	No
Secondary	Changes in inflammation and oxidation markers		At baseline and endpoint of each phase	Yes