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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safflower oil | Placebo Comparator | This arm of the study constitutes the control phase |
|
| Clarinol G-80® | Experimental |
| |
| G-c9, t11 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarinol G-80 ® treatment | Dietary Supplement | 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%). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight, body fat mass, and lean body mass | At baseline and endpoint of each phase |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inflammation and oxidation markers | At baseline and endpoint of each phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter JH Jones, Ph.D. | University of Manitoba | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21593349 | Derived | Joseph SV, Jacques H, Plourde M, Mitchell PL, McLeod RS, Jones PJ. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men. J Nutr. 2011 Jul;141(7):1286-91. doi: 10.3945/jn.110.135087. Epub 2011 May 18. |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D006949 | Hyperlipidemias |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D012450 | Safflower Oil |
| D018801 | CD2 Antigens |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Safflower oil | Dietary Supplement | 3.5 g/d of safflower oil |
|
| G-c9, t11 | Dietary Supplement | 3.5 g/day of c9, t11 CLA |
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |