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Effect of Fish Oil on Insulin Sensitivity

NCT ID: NCT01241474

Last Updated: 2012-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome X Type 2 Diabetes Mellitus Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fish oil

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_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) oil

Group Type PLACEBO_COMPARATOR

Maize (corn) oil

Intervention Type DIETARY_SUPPLEMENT

6 x 1g capsules per day for 9 months

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Maize (corn) oil

6 x 1g capsules per day for 9 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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EPAX 6000TG code F0-5222/XT Banner chemicals product GL-518/XT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerald E Lobley, BSc PhD

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute of Nutrition and Health, University of Aberdeen

Locations

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Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UofAberdeen RINH HNU800

Identifier Type: -

Identifier Source: org_study_id