Novel Dietary Interventions for Treating Insulin Resistance

Study Overview
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Brief Summary
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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.

Conditions
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Insulin Resistance, Obesity, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Fish Oil
* Dietary Supplement: Polyphenol Capsules
* Dietary Supplement: Corn Oil Capsules
* Dietary Supplement: Corn starch capsules
* Other: Reduced glycemic index bread products
* Other: Market variety bread products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI): 30.0-40.9 kg/m^2 Metabolic Syndrome Exclusion Criteria: Diabetes Inflammatory diseases Eating disorders Pregnancy Known kidney, coronary, gastrointestinal or peripheral artery disease Smoking Recent fish oil (>500mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/day) or polyphenol supplement use Recent weight change Strenuous exercise Fish/food allergies Current diabetic, lipid-lowering (fibrates, statins), anti-inflammatory, immune-suppressant, and/or anti-inflammatory hypertension medication use

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Diet<br>Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules. | Dietary Supplement: Fish Oil<br>* fish oil capsules<br>Dietary Supplement: Polyphenol Capsules<br>* delphinidin polyphenol capsules<br>Other: Reduced glycemic index bread products<br>* Made by Zone Labs<br>|
| Placebo Comparator: Placebo Diet<br>Market variety bread products, corn oil capsules, and corn starch capsules. | Dietary Supplement: Corn Oil Capsules<br>* Corn Oil Capsules<br>Dietary Supplement: Corn starch capsules<br>* Maltodextrin capsules<br>Other: Market variety bread products<br>* placebo bread products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Monocytes