Insulin Resistance, Obesity, Metabolic Syndrome
Conditions
Keywords
Inflammation, Monocytes
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.
Interventions
DIETARY_SUPPLEMENTFish Oil
fish oil capsules
DIETARY_SUPPLEMENTPolyphenol Capsules
delphinidin polyphenol capsules
DIETARY_SUPPLEMENTCorn Oil Capsules
Corn Oil Capsules
DIETARY_SUPPLEMENTCorn starch capsules
Maltodextrin capsules
OTHERReduced glycemic index bread products
Made by Zone Labs
OTHERMarket variety bread products
placebo bread products
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin resistance | Baseline, 6 weeks, and 12 weeks | Fasting plasma insulin, Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inflammation biomarkers | Baseline, 6 weeks, 12 weeks | Fasting plasma cytokines and C-reactive protein (CRP), monocyte expression of inflammatory genes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in adipokines | Baseline, 6 weeks, 12 weeks | Fasting plasma adiponectin and leptin |
Countries
United States
Outcome results
None listed