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Effect of Fish Oil on Insulin Sensitivity

Primary Purpose

Metabolic Syndrome X, Type 2 Diabetes Mellitus, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates
Maize (corn) oil
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome X

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rowett Institute of Nutrition and Health, University of Aberdeen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish oil

Maize (corn) oil

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes
Change in plasma inflammatory markers

Full Information

First Posted
November 10, 2010
Last Updated
August 6, 2012
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT01241474
Brief Title
Effect of Fish Oil on Insulin Sensitivity
Official Title
Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X, Type 2 Diabetes Mellitus, Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Title
Maize (corn) oil
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates
Other Intervention Name(s)
EPAX 6000TG code F0-5222/XT
Intervention Description
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
Intervention Name(s)
Maize (corn) oil
Other Intervention Name(s)
Banner chemicals product GL-518/XT
Intervention Description
6 x 1g capsules per day for 9 months
Primary Outcome Measure Information:
Title
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp
Time Frame
0 months and 9 months
Secondary Outcome Measure Information:
Title
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
Title
Change in plasma inflammatory markers
Time Frame
0, 4 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and post-menopausal women aged 40-65 years Recruited from the surrounding community of Aberdeen Insulin resistance with either venous plasma fasting glucose > 5.0, < 7.0 mmo/l, venous plasma 2-h 75-g OGTT > 5.0, < 11.1 mmol/l 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald E Lobley, BSc PhD
Organizational Affiliation
Rowett Institute of Nutrition and Health, University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rowett Institute of Nutrition and Health, University of Aberdeen
City
Aberdeen
ZIP/Postal Code
AB21 9SB
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Fish Oil on Insulin Sensitivity

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