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Clinical and rodent studies have demonstrated the impact of specific dietary factors in modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and glycemic index. The investigators know from previous studies in the literature that reducing the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results in improved metabolic indices and reduced inflammation. These improvements can be observed even within the context of persistent obesity. The investigators will implement a reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and reducing inflammation in obese subjects with the metabolic syndrome. The active diet will include reduced glycemic index foods together with omega-3 fats and polyphenol supplements. The primary hypothesis is that the dietary combination of reduced glycemic index foods, omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese subjects with the metabolic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Diet | Experimental | Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules. |
|
| Placebo Diet | Placebo Comparator | Market variety bread products, corn oil capsules, and corn starch capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish Oil | Dietary Supplement | fish oil capsules |
| |
| Polyphenol Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin resistance | Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) | Baseline, 6 weeks, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammation biomarkers | Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adipokines | Fasting plasma adiponectin and leptin | Baseline, 6 weeks, 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Sears, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D059808 | Polyphenols |
| D003314 | Corn Oil |
| D013213 | Starch |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 |
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| Dietary Supplement |
delphinidin polyphenol capsules |
|
| Corn Oil Capsules | Dietary Supplement | Corn Oil Capsules |
|
| Corn starch capsules | Dietary Supplement | Maltodextrin capsules |
|
| Reduced glycemic index bread products | Other | Made by Zone Labs |
|
| Market variety bread products | Other | placebo bread products |
|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |