Effect of Fish Oil on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01241474
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
University of Aberdeen

November 10, 2010
November 16, 2010
August 7, 2012
February 2009
June 2012   (Final data collection date for primary outcome measure)
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp [ Time Frame: 0 months and 9 months ]
Change in insulin sensitivity assessed by hyperinsulinaemic-euglycaemic-euaminoacidaemic clamp [ Time Frame: 0 months and 9 months ]
Complete list of historical versions of study NCT01241474 on Archive Site
  • 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 ]
  • Change in plasma inflammatory markers [ Time Frame: 0, 4 and 9 months ]
Same as current
Not Provided
Not Provided
Effect of Fish Oil on Insulin Sensitivity
Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Metabolic Syndrome X
  • Type 2 Diabetes Mellitus
  • Sarcopenia
  • Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates
    6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period
    Other Name: EPAX 6000TG code F0-5222/XT
  • Dietary Supplement: Maize (corn) oil
    6 x 1g capsules per day for 9 months
    Other Name: Banner chemicals product GL-518/XT
  • Experimental: Fish oil
    Intervention: Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates
  • Placebo Comparator: Maize (corn) oil
    Intervention: Dietary Supplement: Maize (corn) oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and post-menopausal women aged 40-65 years
  • Recruited from the surrounding community of Aberdeen
  • Insulin resistance with either

    1. venous plasma fasting glucose > 5.0, < 7.0 mmo/l,
    2. venous plasma 2-h 75-g OGTT > 5.0, < 11.1 mmol/l
    3. 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
Sexes Eligible for Study: All
40 Years to 69 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
UofAberdeen RINH HNU800
Not Provided
Not Provided
University of Aberdeen
University of Aberdeen
Not Provided
Principal Investigator: Gerald E Lobley, BSc PhD Rowett Institute of Nutrition and Health, University of Aberdeen
University of Aberdeen
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP