Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Celia Walker
ORCID ID
Contact details
MRC Human Nutrition Research
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
+44 (0)1223 426356
celia.walker@mrc-hnr.cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N05065/N05066
Study information
Scientific title
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
Acronym
FISH
Study hypothesis
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.
Ethics approval
Suffolk Research Ethics Committee (REC), approved on 06/02/2006 (ref: 05/Q0102/181)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
Impact of fish-oil consumption on the fatty acid content of plasma
Intervention
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)
Intervention type
Drug
Phase
Not Applicable
Drug names
Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA)
Primary outcome measure
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
Secondary outcome measures
Current secondary outcome measures as of 17/01/2019:
Secondary comparisons will include gender effects, additional age comparisons and within-group time relationships (i.e. up to 12 months). 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); EPA status of fatty acid pools, EPA plus DHA status of fatty acid pools, other fatty acids, adipose tissue lipidome, and plasma markers of inflammation and physiological function including lipid mediators (i.e. oxylipins).
Previous secondary outcome measures:
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).
Overall trial start date
01/05/2006
Overall trial end date
28/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Men and women, aged 20-80 years with a body mass index (BMI) in the range 18-35 kg/m2 will be recruited to the study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
210
Participant exclusion criteria
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
Recruitment start date
01/05/2006
Recruitment end date
28/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
Funders
Funder type
Government
Funder name
Food Standards Agency (UK) (ref: N05065/N05066)
Alternative name(s)
FSA
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 lipid pool results in: http://www.ncbi.nlm.nih.gov/pubmed/22932281
2. 2014 blood cell and plasma results in: http://www.ncbi.nlm.nih.gov/pubmed/24647395
3. 2014 results on effects of sex and age in https://www.ncbi.nlm.nih.gov/pubmed/24063767
4. 2015 results on use of plasma NEFA as a biomarker in https://www.ncbi.nlm.nih.gov/pubmed/26205910
5. 2015 results on differences in FA distribution between blood cells and plasma in https://www.ncbi.nlm.nih.gov/pubmed/26247960
6. 2017 lipidomics analysis results in https://www.ncbi.nlm.nih.gov/pubmed/28587463
Publication citations
-
Results
Browning LM, Walker CG, Mander AP, West AL, Madden J, Gambell JM, Young S, Wang L, Jebb SA, Calder PC, Incorporation of eicosapentaenoic and docosahexaenoic acids into lipid pools when given as supplements providing doses equivalent to typical intakes of oily fish., Am. J. Clin. Nutr., 2012, 96, 4, 748-758, doi: 10.3945/ajcn.112.041343.
-
Results
Browning LM, Walker CG, Mander AP, West AL, Gambell J, Madden J, Calder PC, Jebb SA, Compared with daily, weekly n-3 PUFA intake affects the incorporation of eicosapentaenoic acid and docosahexaenoic acid into platelets and mononuclear cells in humans., J. Nutr., 2014, 144, 5, 667-672, doi: 10.3945/jn.113.186346.