Effect of Fish Oil on Insulin Sensitivity

University of Aberdeen34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Metabolic Syndrome X Type 2 Diabetes Mellitus Sarcopenia

Interventions

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

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

Maize (corn) oilDIETARY_SUPPLEMENT

6 x 1g capsules per day for 9 months

Eligibility

Sex: ALLMin age: 40 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 0 months and 9 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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