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Trial record 54 of 76 for:    Long-chain fatty acids

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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Type 2 Diabetes Mellitus Sarcopenia Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates Dietary Supplement: Maize (corn) oil Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation
Study Start Date : February 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Fish oil 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

Placebo Comparator: Maize (corn) oil Dietary Supplement: Maize (corn) oil
6 x 1g capsules per day for 9 months
Other Name: Banner chemicals product GL-518/XT

Primary Outcome Measures :
  1. Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp [ Time Frame: 0 months and 9 months ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01241474

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United Kingdom
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, United Kingdom, AB21 9SB
Sponsors and Collaborators
University of Aberdeen
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Principal Investigator: Gerald E Lobley, BSc PhD Rowett Institute of Nutrition and Health, University of Aberdeen

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Responsible Party: University of Aberdeen Identifier: NCT01241474     History of Changes
Other Study ID Numbers: UofAberdeen RINH HNU800
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: August 7, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Metabolic Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs