NCT01047280

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

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

Interventions

Type	Name	Description
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%).
DIETARY_SUPPLEMENT	Safflower oil	3.5 g/d of safflower oil
DIETARY_SUPPLEMENT	G-c9, t11	3.5 g/day of c9, t11 CLA

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-03-01
• Completion: 2009-05-01
• First posted: 2010-01-12
• Last updated: 2010-01-12