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Novel Dietary Interventions for Treating Insulin Resistance

Primary Purpose

Insulin Resistance, Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fish Oil
Polyphenol Capsules
Corn Oil Capsules
Corn starch capsules
Reduced glycemic index bread products
Market variety bread products
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Inflammation, Monocytes

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Diet

Placebo Diet

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2013
Last Updated
December 10, 2013
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02006394
Brief Title
Novel Dietary Interventions for Treating Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity, Metabolic Syndrome
Keywords
Inflammation, Monocytes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Diet
Arm Type
Experimental
Arm Description
Reduced glycemic index bread products, fish oil capsules, and polyphenol capsules.
Arm Title
Placebo Diet
Arm Type
Placebo Comparator
Arm Description
Market variety bread products, corn oil capsules, and corn starch capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Intervention Description
fish oil capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyphenol Capsules
Intervention Description
delphinidin polyphenol capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn Oil Capsules
Intervention Description
Corn Oil Capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Corn starch capsules
Intervention Description
Maltodextrin capsules
Intervention Type
Other
Intervention Name(s)
Reduced glycemic index bread products
Intervention Description
Made by Zone Labs
Intervention Type
Other
Intervention Name(s)
Market variety bread products
Intervention Description
placebo bread products
Primary Outcome Measure Information:
Title
Change in insulin resistance
Description
Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
Time Frame
Baseline, 6 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Change in inflammation biomarkers
Description
Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes
Time Frame
Baseline, 6 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in adipokines
Description
Fasting plasma adiponectin and leptin
Time Frame
Baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Sears, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

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Novel Dietary Interventions for Treating Insulin Resistance

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