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Novel Dietary Interventions for Treating Insulin Resistance

NCT02006394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2013-12-12

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Fish Oil

fish oil capsules

DIETARY_SUPPLEMENT

Polyphenol Capsules

delphinidin polyphenol capsules

DIETARY_SUPPLEMENT

Corn Oil Capsules

Corn Oil Capsules

DIETARY_SUPPLEMENT

Corn starch capsules

Maltodextrin capsules

OTHER

Reduced glycemic index bread products

Made by Zone Labs

OTHER

Market variety bread products

placebo bread products

Sponsors & Collaborators

Principal Investigators

  • Dorothy Sears, PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-07-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006394 on ClinicalTrials.gov