Novel Dietary Interventions for Treating Insulin Resistance

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006394
• Other study ID #: IRB #110549
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 10, 2013
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Fish Oil
fish oil capsules
• Polyphenol Capsules
delphinidin polyphenol capsules
• Corn Oil Capsules
Corn Oil Capsules
• Corn starch capsules
Maltodextrin capsules

Other:
• Reduced glycemic index bread products
Made by Zone Labs
• Market variety bread products
placebo bread products

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in adipokines	Fasting plasma adiponectin and leptin	Baseline, 6 weeks, 12 weeks	No
Primary	Change in insulin resistance	Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)	Baseline, 6 weeks, and 12 weeks	No
Secondary	Change in inflammation biomarkers	Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes	Baseline, 6 weeks, 12 weeks	No