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Completed

NCT Number: NCT01215903

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Laval University

Québec, Quebec, G1V 0A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish gelatin and omega-3 polyunsaturated fatty acid

Dietary Supplement

Omega-3 Polyunsaturated Fatty Acid

Dietary Supplement

Primary outcomes

  1. Insulin sensitivity

    Time frame: At 8 weeks

  2. Plasma lipids and lipoproteins

    Time frame: at 8 weeks

  3. Blood pressure

    Time frame: At 8 weeks

  4. Plasma and serum inflammatory markers

    Time frame: At 8 weeks

Secondary outcomes

  1. Glucose tolerance

    Time frame: At 8 weeks

  2. Energy intake

    Time frame: At 8 weeks

  3. Fatty acids of phospholipids in skeletal muscle

    Time frame: At 8 weeks

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Advance Foods and Materials Network
  • Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)
  • Kenney & Ross
  • Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements)
  • University of Guelph

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 7, 2010
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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