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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
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp [ Time Frame: 0 months and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241474

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

No publications provided

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT01241474     History of Changes
Other Study ID Numbers: UofAberdeen RINH HNU800
Study First Received: November 10, 2010
Last Updated: August 6, 2012
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Sarcopenia
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013