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The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Flavonoids then High Flavonoids | Experimental | Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. |
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| High Flavonoids then Low Flavonoids | Experimental | Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dietary Flavonoids | Other | A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing high levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids. |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal calprotectin | Primary endpoint for intestinal inflammation | 6 weeks |
| Serum C-reactive protein | One of two primary endpoints for systemic inflammation | 6 weeks |
| Serum soluble tumor necrosis factor receptor-1 | One of two primary endpoints for systemic inflammation | 6 weeks |
| Serum insulin | Primary endpoint for insulin resistance | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiome composition | Includes relative abundances of operational taxonomic units and assigned taxonomy as well as alpha and beta diversity measurements | 6 weeks |
| Fecal short chain fatty acids |
| Measure | Description | Time Frame |
|---|---|---|
| Serum resistin | Measure of adipocyte inflammation and systemic metabolism | 6 weeks |
| Serum visfatin | Measure of adipocyte inflammation and systemic metabolism |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Lefevre, PhD | Utah State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Utah State University, Center for Human Nutrition Studies | Logan | Utah | 84322-9815 | United States |
De-identified individual data will be deposited into a public repository as the data are published.
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low Dietary Flavonoids | Other | A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing low levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids. |
|
Measure of fecal microbiome metabolic capabilities and includes acetate, propionate, butyrate, valerate and caproate.
| 6 weeks |
| Fecal eosinophil protein X | Secondary endpoint for intestinal inflammation | 6 weeks |
| Fecal myeloperoxidase | Secondary endpoint for intestinal inflammation | 6 weeks |
| Intestinal permeability by four sugar differential absorption test | Secondary endpoint for intestinal inflammation | 6 weeks |
| Serum endotoxin | Secondary endpoint for intestinal inflammation | 6 weeks |
| Serum interleukin-6 | Secondary endpoint for systemic inflammation | 6 weeks |
| Serum soluble tumor necrosis factor receptor-2 | Secondary endpoint for systemic inflammation | 6 weeks |
| Serum fasting glucose | Secondary endpoint for insulin resistance | 6 weeks |
| Calculated Homeostatic Model Assessment-Insulin Resistance | Secondary endpoint for insulin resistance | 6 weeks |
| Serum C-peptide | Secondary endpoint for insulin resistance | 6 weeks |
| Plasma lipids | Secondary endpoint for insulin resistance. Includes LDL-cholesterol, HDL-cholesterol and triglycerides | 6 weeks |
| Blood pressure | Secondary endpoint for insulin resistance. Includes systolic and diastolic blood pressure | 6 weeks |
| 6 weeks |
| Serum adiponectin | Measure of adipocyte inflammation and systemic metabolism | 6 weeks |
| Serum leptin | Measure of adipocyte inflammation and systemic metabolism | 6 weeks |
| Body weight | 6 weeks |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |