Novel Dietary Interventions for Treating Insulin Resistance

University of California San Diego

Status: Completed

Conditions: Insulin Resistance; Obesity; Metabolic Syndrome

Treatments: Other: Reduced glycemic index bread products; Dietary Supplement: Fish Oil; Other: Market variety bread products; Dietary Supplement: Corn Oil Capsules; Dietary Supplement: Corn starch capsules; Dietary Supplement: Polyphenol Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02006394

IRB #110549

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups, including a placebo group

Active Diet

Experimental group

Description:

Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.

Treatment:

Other: Reduced glycemic index bread products

Dietary Supplement: Fish Oil

Dietary Supplement: Polyphenol Capsules

Placebo Diet

Placebo Comparator group

Description:

Market variety bread products, corn oil capsules, and corn starch capsules.

Treatment:

Other: Market variety bread products

Dietary Supplement: Corn Oil Capsules

Dietary Supplement: Corn starch capsules