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OpenTrials
Completed

NCT Number: NCT02006394

Novel Dietary Interventions for Treating Insulin Resistance

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.

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Key information

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish Oil

Dietary Supplement

fish oil capsules

Polyphenol Capsules

Dietary Supplement

delphinidin polyphenol capsules

Corn Oil Capsules

Dietary Supplement

Corn Oil Capsules

Corn starch capsules

Dietary Supplement

Maltodextrin capsules

Reduced glycemic index bread products

Other

Made by Zone Labs

Market variety bread products

Other

placebo bread products

Primary outcomes

  1. Change in insulin resistance

    Time frame: Baseline, 6 weeks, and 12 weeks

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

Secondary outcomes

  1. Change in inflammation biomarkers

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes

Other outcomes

  1. Change in adipokines

    Time frame: Baseline, 6 weeks, 12 weeks

    Fasting plasma adiponectin and leptin

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2013
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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