Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/03/2006
Date assigned
28/04/2006
Last edited
11/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Eligibility

Participant inclusion criteria

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.

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

Sponsor information

Organisation

MRC Human Nutrition Research (UK)

Sponsor details

Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom

Sponsor type

Research council

Website

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

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22932281
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24647395

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes