Metabolic Syndrome XNCT01241474
Effect of Fish Oil on Insulin Sensitivity
A study testing EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates and Maize (corn) oil in people with Metabolic Syndrome X and Type 2 Diabetes Mellitus, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Metabolic Syndrome X, Type 2 Diabetes Mellitus, Sarcopenia
- What is being tested?
- EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates and Maize (corn) oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 11Show fewer
- Cardiovascular disease
- Malignancy
- Thromboembolic or coagulation disorders
- Alcoholism or other substance misuse
- Eating disorders or significant psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute of Nutrition and Health, University of Aberdeen
Aberdeen, AB21 9SB
About this study
Official title: Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation
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.
Read the 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.
- Conditions
- Metabolic Syndrome X, Type 2 Diabetes Mellitus, Sarcopenia
- Being tested
- EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates, Maize (corn) oil
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentratesDietary supplement
Also called EPAX 6000TG code F0-5222/XT
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
Also called Banner chemicals product GL-518/XT
6 x 1g capsules per day for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Not described Receives: Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates |
| Maize (corn) oil | Placebo comparator | Not described Receives: Dietary Supplement: Maize (corn) oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp
Measured: 0 months and 9 months
Secondary outcomes (2)
Change in amount of docosahexaenoic acid and eicosapentaenoic acid incorporated into phospholipid fraction of red blood cell membranes
Measured: at monthly intervals between 0 and 9 months
Change in plasma inflammatory markers
Measured: 0, 4 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerald E Lobley, BSc PhD, Principal investigator, Rowett Institute of Nutrition and Health, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241474
- Sponsor's protocol ID
- UofAberdeen RINH HNU800
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2010
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Long-chain n-3 PUFA Supplement and Insulin Action in Human Subjects With Impaired Glucose Regulation
- ClinicalTrials.gov ID
- NCT01241474
- Acronym / sponsor ID
- UofAberdeen RINH HNU800
- Conditions
- Metabolic Syndrome X, Type 2 Diabetes Mellitus, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Experimental | Dietary Supplement: EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates |
| Maize (corn) oil | Placebo comparator | Dietary Supplement: Maize (corn) oil |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and post-menopausal women aged 40-65 years
- Recruited from the surrounding community of Aberdeen
- Insulin resistance with either
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentratesAlso: EPAX 6000TG code F0-5222/XT6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period | Dietary supplement | Fish oil |
| Maize (corn) oilAlso: Banner chemicals product GL-518/XT6 x 1g capsules per day for 9 months | Dietary supplement | Maize (corn) oil |
Primary outcome
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp
Time frame: 0 months and 9 months
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
Related trials for Metabolic Syndrome X
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 1/2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Obesity, Metabolic Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald E Lobley, BSc PhD principal investigator
Rowett Institute of Nutrition and Health, University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates and Maize (corn) oil in people with Metabolic Syndrome X and Type 2 Diabetes Mellitus, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity assessed by hyperinsulinemic-euglycemic-eu-aminoacidemic clamp (time frame: 0 months and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2012.