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

Laval University

Status and phase: Completed; Phase 2

Conditions: Insulin Resistance; Type 2 Diabetes

Treatments: Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid; Dietary Supplement: Omega-3 polyunsaturated fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01215903

SIRUL-85742

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Fish gelatin and omega-3

Experimental group

Treatment:

Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid

Omega-3

Experimental group

Treatment:

Dietary Supplement: Omega-3 polyunsaturated fatty acid