Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance

Study Overview
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Brief Summary
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The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.

Detailed Description
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An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.

Official Title
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The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile

Conditions
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Insulin Resistance, Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid
* Dietary Supplement: Omega-3 polyunsaturated fatty acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese (body mass index [BMI] between 25 and 40kg/m2) fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L fasting plasma insulin above 90pmol/L Exclusion Criteria: Diabetes, chronic, metabolic or acute disease Major surgery within the last 3 months Significant weight loss (±10%) within the last 6 months Any medication-taking known to affect lipid of glucose metabolism Allergy, intolerance or dislike of fish Smokers

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fish gelatin and omega-3<br> | Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid<br> <br> |
| Experimental: Omega-3<br> | Dietary Supplement: Omega-3 polyunsaturated fatty acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | At 8 weeks | 
| Plasma lipids and lipoproteins |  | at 8 weeks | 
| Blood pressure |  | At 8 weeks | 
| Plasma and serum inflammatory markers |  | At 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance |  | At 8 weeks | 
| Energy intake |  | At 8 weeks | 
| Fatty acids of phospholipids in skeletal muscle |  | At 8 weeks |