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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01215903

Enrollment

Registered

2010-10-07

Start date

2007-11-30

Completion date

2009-05-31

Last updated

2010-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Type 2 Diabetes

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTFish gelatin and omega-3 polyunsaturated fatty acid

DIETARY_SUPPLEMENTOmega-3 polyunsaturated fatty acid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Energy intake	At 8 weeks
Fatty acids of phospholipids in skeletal muscle	At 8 weeks
Glucose tolerance	At 8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026