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Novel Dietary Interventions for Treating Insulin Resistance

NCT ID: NCT02006394

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-11-30

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.

Detailed Description

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Conditions

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Insulin Resistance Obesity Metabolic Syndrome

Keywords

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Inflammation Monocytes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Diet

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

Group Type EXPERIMENTAL

Fish Oil

Intervention Type DIETARY_SUPPLEMENT

fish oil capsules

Polyphenol Capsules

Intervention Type DIETARY_SUPPLEMENT

delphinidin polyphenol capsules

Reduced glycemic index bread products

Intervention Type OTHER

Made by Zone Labs

Placebo Diet

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

Group Type PLACEBO_COMPARATOR

Corn Oil Capsules

Intervention Type DIETARY_SUPPLEMENT

Corn Oil Capsules

Corn starch capsules

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin capsules

Market variety bread products

Intervention Type OTHER

placebo bread products

Interventions

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Fish Oil

fish oil capsules

Intervention Type DIETARY_SUPPLEMENT

Polyphenol Capsules

delphinidin polyphenol capsules

Intervention Type DIETARY_SUPPLEMENT

Corn Oil Capsules

Corn Oil Capsules

Intervention Type DIETARY_SUPPLEMENT

Corn starch capsules

Maltodextrin capsules

Intervention Type DIETARY_SUPPLEMENT

Reduced glycemic index bread products

Made by Zone Labs

Intervention Type OTHER

Market variety bread products

placebo bread products

Intervention Type OTHER

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Dorothy Sears

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorothy Sears, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #110549

Identifier Type: -

Identifier Source: org_study_id