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Effect of Fish Oil on Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01241474
First received: November 10, 2010
Last updated: August 6, 2012
Last verified: August 2012

November 10, 2010
August 6, 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 ] [ Designated as safety issue: No ]
Change in insulin sensitivity assessed by hyperinsulinaemic-euglycaemic-euaminoacidaemic clamp [ Time Frame: 0 months and 9 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01241474 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
  • Change in plasma inflammatory markers [ Time Frame: 0, 4 and 9 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
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
Both
40 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01241474
UofAberdeen RINH HNU800
Yes
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