Novel Dietary Interventions for Treating Insulin Resistance

Not Applicable

Completed

• Conditions: Obesity; Metabolic Syndrome; Insulin Resistance
• Interventions: Dietary Supplement: Fish Oil; Dietary Supplement: Corn Oil Capsules; Dietary Supplement: Corn starch capsules; Dietary Supplement: Polyphenol Capsules; Other: Reduced glycemic index bread products; Other: Market variety bread products

• Registration Number: NCT02006394
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-07
• Study Completion: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-10
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Diet	Corn starch capsules	Market variety bread products, corn oil capsules, and corn starch capsules.
Active Diet	Fish Oil	Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.
Active Diet	Polyphenol Capsules	Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.
Active Diet	Reduced glycemic index bread products	Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.
Placebo Diet	Corn Oil Capsules	Market variety bread products, corn oil capsules, and corn starch capsules.
Placebo Diet	Market variety bread products	Market variety bread products, corn oil capsules, and corn starch capsules.

Primary Outcome Measures

Name	Time	Method
Change in insulin resistance	Baseline, 6 weeks, and 12 weeks	Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)

Secondary Outcome Measures

Name	Time	Method
Change in inflammation biomarkers	Baseline, 6 weeks, 12 weeks	Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States