Novel Dietary Interventions for Treating Insulin Resistance

NCT02006394 | Completed

• 1 other identifier: IRB #110549
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Obesity; Metabolic Syndrome

Keywords

Inflammation; Monocytes

Outcome Measures

Primary Outcomes (1)

• Change in insulin resistance

  Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (1)

• Change in inflammation biomarkers

  Baseline, 6 weeks, 12 weeks

Other Outcomes (1)

• Change in adipokines

  Baseline, 6 weeks, 12 weeks

Study Arms (2)

Active Diet

EXPERIMENTAL

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

Dietary Supplement: Fish Oil; Dietary Supplement: Polyphenol Capsules; Other: Reduced glycemic index bread products

Placebo Diet

PLACEBO COMPARATOR

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

Dietary Supplement: Corn Oil Capsules; Dietary Supplement: Corn starch capsules; Other: Market variety bread products

Interventions

Fish Oil DIETARY_SUPPLEMENT

fish oil capsules

Active Diet

Polyphenol Capsules DIETARY_SUPPLEMENT

delphinidin polyphenol capsules

Active Diet

Corn Oil Capsules DIETARY_SUPPLEMENT

Corn Oil Capsules

Placebo Diet

Corn starch capsules DIETARY_SUPPLEMENT

Maltodextrin capsules

Placebo Diet

Reduced glycemic index bread products OTHER

Made by Zone Labs

Active Diet

Market variety bread products OTHER

placebo bread products

Placebo Diet

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI): 30.0-40.9 kg/m\^2
• Metabolic Syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity; Metabolic Syndrome; Inflammation

Interventions

Fish Oils; Polyphenols; Corn Oil; Starch

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Oils; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Dorothy Sears, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (1)