Effect of Fish Oil on Insulin Sensitivity

Not Applicable

Completed

• Conditions: Metabolic Syndrome X; Type 2 Diabetes Mellitus; Sarcopenia
• Interventions: Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates; Dietary Supplement: Maize (corn) oil

• Registration Number: NCT01241474
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates	-
Maize (corn) oil	Maize (corn) oil	-

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp	0 months and 9 months

Secondary Outcome Measures

Name	Time	Method
Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes	at monthly intervals between 0 and 9 months
Change in plasma inflammatory markers	0, 4 and 9 months

Trial Locations

Locations (1)

Rowett Institute of Nutrition and Health, University of Aberdeen; 🇬🇧 Aberdeen, United Kingdom