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| Name | Class |
|---|---|
| National Dairy Council | OTHER |
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The objectives of this trial are to assess the effects of adding 2 servings/d of either full-fat or low-fat fermented dairy products to the diet, as a replacement for non-dairy foods with macronutrient composition similar to the low-fat fermented dairy condition, on insulin sensitivity, erythrocyte fatty acid profile and other cardiometabolic health markers in metabolically at-risk adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-fat fermented dairy | Experimental | 1 serving per day of full-fat yogurt and full-fat fermented cheese |
|
| Low-fat fermented dairy | Active Comparator | 1 serving per day of low-fat yogurt and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese). |
|
| Non-dairy, non-fermented foods | Placebo Comparator | 2 servings per day of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full-fat fermented dairy | Other | Subjects assigned to the full-fat fermented dairy condition will consume 1 serving/d each of full-fat yogurt (plain or reduced sugar varieties) and full-fat fermented cheese. |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity | The percent change from baseline to the end of treatment at 12 weeks in the Matsuda index | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Carbohydrate metabolism variables | Changes or percent changes from baseline to the end of treatment of fasting glucose and insulin, liquid meal tolerance test (LMTT) disposition index and homeostasis model assessments of pancreatic beta-cell function (HOMA2%B) and insulin sensitivity (HOMA2%S). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | MB Clinical Research & Consulting, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excellence Medical and Research | Miami Gardens | Florida | 33169 | United States | ||
| Illinois Institute of Technology |
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| Low-fat fermented dairy | Other | Subjects assigned to the low-fat fermented dairy condition will consume 1 serving/d each of low-fat yogurt (plain or reduced sugar varieties) and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese). |
|
| Non-dairy, non-fermented foods | Other | Subjects assigned to the control condition will consume 2 servings/d of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition. |
|
| Lipid variables |
Changes or percent changes from baseline to end of treatment of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, TG; lipoprotein particle concentrations and subfractions. |
| 12 weeks |
| Erythrocyte | Changes or percent changes from baseline to the end of treatment of Erythrocyte 15:0, 17:0 and 1-16:1n-7 content (expressed as % of total fatty acids) | 12 weeks |
| High-sensitivity C-reactive proten (hs-CRP) | Changes or percent changes from baseline to the end of treatment | 12 weeks |
| Waist circumference | Changes or percent changes from baseline to the end of treatment | 12 weeks |
| Seated, resting systolic and diastolic blood pressures and heart rate | Changes or percent changes from baseline to the end of treatment | 12 weeks |
| Chicago |
| Illinois |
| 60616 |
| United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Great Lakes Clinical Trials | Gurnee | Illinois | 60031 | United States |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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