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
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
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
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
NCT ID
NCT01241474
First Posted
November 10, 2010
Last Updated
August 6, 2012
Sponsor
University of Aberdeen
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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