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Completed

NCT Number: NCT01241474

Effect of Fish Oil on Insulin Sensitivity

The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine oil improves insulin sensitivity and glucose control in subjects with impaired glucose regulation.

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Key information

About this study

The incidence of Type 2 diabetes is related both to age and obesity. The disease impacts on quality of life and treatments represent a major health cost. Prevention or delayed onset of the disease remains a key target. Animal studies have shown that provision of high amounts of fish oil in the diet improves insulin sensitivity but human trials have proved equivocal. Recent dose-response trials in animals have shown the improved insulin sensitivity only occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 PUFA), docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid fraction within tissue cell membranes. To achieve such values in humans would require a high dose of n-3 PUFA supplied over a prolonged period of time. This is tested within the current study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic acid plus eicosapentaenoic acid) is supplied for 9 months. As well as improving control of glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the impact of frailty in older subjects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and post-menopausal women aged 40-65 years
  • Recruited from the surrounding community of Aberdeen
  • Insulin resistance with either
  • venous plasma fasting glucose > 5.0, < 7.0 mmo/l,
  • venous plasma 2-h 75-g OGTT > 5.0, < 11.1 mmol/l
  • newly diagnosed with type 2 diabetes; must be asymptomatic and detected during our screenings and not require oral hypoglycemic or insulin therapy, HbA1c < 7.0%

Exclusion criteria

  • Diabetes requiring oral hypoglycemic therapy or insulin
  • Treatment with anticoagulants, regular steroids or non-steroidal anti-inflammatory drug treatment, tricyclic antidepressants, anti-arrhythmics
  • Hepatic failure
  • Renal failure
  • Significant respiratory disease
  • Anaemia
  • Cardiovascular disease
  • Malignancy
  • Thromboembolic or coagulation disorders
  • Alcoholism or other substance misuse
  • Eating disorders or significant psychiatric disorders

Treatment and study plan

EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates

Dietary Supplement

6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period

Other names: EPAX 6000TG code F0-5222/XT

Maize (corn) oil

Dietary Supplement

6 x 1g capsules per day for 9 months

Other names: Banner chemicals product GL-518/XT

Primary outcomes

  1. Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp

    Time frame: 0 months and 9 months

Secondary outcomes

  1. Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes

    Time frame: at monthly intervals between 0 and 9 months

  2. Change in plasma inflammatory markers

    Time frame: 0, 4 and 9 months

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Official study title

Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 16, 2010
Registry last updated
Aug 7, 2012

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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