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ISRCTN
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ISRCTN48398526
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DOI
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10.1186/ISRCTN48398526
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Assessing the impact of escalating fish oil consumption on n-3 polyunsaturated fatty acid (PUFA) content of transport, storage and functional pools
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Scientific title
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Assessing the impact of escalating fish oil consumption on n-3 polyunsaturated fatty acid (PUFA) content of transport, storage and functional pools: a randomised controlled trial
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Acronym
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FISH
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Serial number at source
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N05065/N05066
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Study hypothesis
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This two-centre study will determine the effect of long-chain (LC) n-3 PUFA supplementation on the fatty acid (FA) content of plasma phospholipids, triacylglycerols, cholesteryl esters and non-esterified fatty acids, platelets, erythrocytes, leukocytes and adipose tissue. Relationships between FA status of different pools and differences according to age and gender will be determined. The intervention is capsule based, to maximise compliance, but will provide LC n-3 PUFA as 'portions' in doses designed to mimic oily fish consumption in free-living.
Please note that, as of 16/01/2009, the anticipated end date of this trial has been amended from 31/12/2008 to 28/02/2009.
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Lay summary
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http://www.mrc-hnr.cam.ac.uk/research/research-sections/diet-population-health/dph-projects/fish-study
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Ethics approval
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Suffolk Research Ethics Committee (REC), approved on 06/02/2006 (ref: 05/Q0102/181)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Impact of fish-oil consumption on the fatty acid content of plasma
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Participants - inclusion criteria
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Men and women, aged 20-80 years with a body mass index (BMI) in the range 18-35 kg/m^2 will be recruited to the study.
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Participants - exclusion criteria
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1. Known diagnosis of diabetes, cancer, cardiovascular disease or other chronic clinical conditions
2. Untreated hypertension
3. Concomitant prescription of anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDS), aspirin, steroids or immunosuppressants
4. Following a special diet, including vegetarians
5. Allergies or intolerance to fish
6. Consumption of oily fish more than once a month
7. Smokers
8. History of substance abuse or alcoholism
9. Pregnant, <1 year post partum or currently planning pregnancy
10. Recent weight change (>2 kg in past 1 month)
11. Planning to change dietary habits, increase physical activity, change body weight, move away from the study centre locality or take a lengthy vacation during the time of the study
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Anticipated start date
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01/05/2006
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Anticipated end date
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28/02/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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210
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Interventions
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The five treatment groups are:
1. Control group (n = 42)
2. Capsules equivalent to 1 portion of oily fish per week (containing approximately 1.8 g eicosapentaenoic acid [EPA] and 1.5 g docosahexaenoic acid [DHA] per week) (n = 42)
3. Capsules equivalent to 2 portions of oily fish per week (containing approximately 3.6 g EPA and 3.0 g DHA per week) (n = 42)
4. Capsules equivalent to 2 portions of oily fish per week, taken continuously rather than in a 'portion' (containing approximately 3.6 g EPA and 3.0 g DHA per week) (n = 42)
5. Capsules equivalent to 4 portions of oily fish per week (containing approximately 7.2 g EPA and 6.0 g DHA per week) (n = 42)
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Primary outcome measure(s)
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The primary outcome is plasma docosahexaenoic acid (DHA) status, expressed as a percentage of total plasma fatty acids.
The three primary comparisons (on which sample size has been calculated) are:
1. Differences in plasma DHA status between treatment groups (2 portions versus control group) at 12 months
2. Differences in plasma DHA status between treatment groups (4 portions versus 2 portions group) at 12 months
3. Difference in plasma DHA status between age groups (old versus young) at 12 months
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Secondary outcome measure(s)
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Secondary comparisons will include gender effects, additional age comparisons and within-group time relationships. Additionally, interactions between portions, age, time and gender will be explored.
Secondary outcomes will include DHA status of other fatty acid pools (also expressed as a percentage of the total fatty acid profile).
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Sources of funding
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Food Standards Agency (UK) (ref: N05065/N05066)
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Trial website
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Publications
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1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22932281
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Contact name
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Dr
Celia
Walker
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Address
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MRC Human Nutrition Research
Fulbourn Road
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City/town
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Cambridge
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Zip/Postcode
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CB1 9NL
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Country
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United Kingdom
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Tel
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+44 (0)1223 426356
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Fax
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+44 (0)1223 437515
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Email
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celia.walker@mrc-hnr.cam.ac.uk
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Sponsor
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MRC Human Nutrition Research (UK)
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Address
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Elsie Widdowson Laboratory
Fulbourn Road
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City/town
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Cambridge
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Zip/Postcode
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CB1 9NL
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Country
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United Kingdom
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Date applied
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21/03/2006
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Last edited
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20/11/2012
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Date ISRCTN assigned
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28/04/2006
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