Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cognis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).
The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safflower Oil | Placebo Comparator | 8.0 g/day safflower oil |
|
| CLA 6.4g/day | Experimental | Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conjugated Linoleic Acid (CLA) | Dietary Supplement | 6.4 g CLA/day, capsule form, for 16 week arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in plasma glucose AUC | significant change in plasma glucose AUC (0-3 h) from baseline to Week 16. | baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| change in insulin sensitivity | baseline and every 4 weeks until week 16 | |
| change in glucose tolerance | baseline and every 4 weeks for 16 weeks | |
| change in HbA1c |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martha A. Belury, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19535429 | Result | Norris LE, Collene AL, Asp ML, Hsu JC, Liu LF, Richardson JR, Li D, Bell D, Osei K, Jackson RD, Belury MA. Comparison of dietary conjugated linoleic acid with safflower oil on body composition in obese postmenopausal women with type 2 diabetes mellitus. Am J Clin Nutr. 2009 Sep;90(3):468-76. doi: 10.3945/ajcn.2008.27371. Epub 2009 Jun 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Safflower OIl | Dietary Supplement | 8.0g/day safflower oil |
|
| baseline and week 16 |
| change in blood lipid profile | baseline and every 4 weeks for 16 weeks |
| change in serum adipocytokines | baseline and every 4 weeks for 16 weeks |
| change in hepatic enzymes | baseline and every 4 weeks for 16 weeks |
| change in body composition | baseline and every 4 weeks for 16 weeks |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D044243 | Linoleic Acids, Conjugated |
| D012450 | Safflower Oil |
| ID | Term |
|---|---|
| D008041 | Linoleic Acids |
| D043371 | Fatty Acids, Omega-6 |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| 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 |
Not provided
Not provided