Assessing the impact of escalating fish oil consumption on n-3 polyunsaturated fatty acid (PUFA) content of transport, storage and functional pools
| ISRCTN | ISRCTN48398526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48398526 |
| Protocol serial number | N05065/N05066 |
| Sponsor | MRC Human Nutrition Research (UK) |
| Funder | Food Standards Agency (UK) (ref: N05065/N05066) |
- Submission date
- 21/03/2006
- Registration date
- 28/04/2006
- Last edited
- 17/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Contact information
Scientific
MRC Human Nutrition Research
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
| Phone | +44 (0)1223 426356 |
|---|---|
| celia.walker@mrc-hnr.cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | FISH |
| Study objectives | 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(s) | Suffolk Research Ethics Committee (REC), approved on 06/02/2006 (ref: 05/Q0102/181) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) |
| Primary outcome measure(s) |
The primary outcome is plasma docosahexaenoic acid (DHA) status, expressed as a percentage of total plasma fatty acids. |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 17/01/2019: |
| Completion date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 28/02/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CB1 9NL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | lipid pool results | 01/10/2012 | Yes | No | |
| Results article | results on effects of sex and age | 01/02/2014 | Yes | No | |
| Results article | blood cell and plasma results | 01/05/2014 | Yes | No | |
| Results article | results on differences in FA distribution between blood cells and plasma | 03/08/2015 | Yes | No | |
| Results article | results on use of plasma NEFA as a biomarker | 14/09/2015 | Yes | No | |
| Results article | lipidomics analysis results | 01/09/2017 | Yes | No |
Editorial Notes
17/01/2019: The following changes have been made:
1. The secondary outcome measures have been changed to include the outcome measures of secondary analyses of the trial data.
2. Publication references added.
