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 |
| Secondary identifying numbers | 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Celia Walker
Scientific
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/05/2006 |
| Completion date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
MRC Human Nutrition Research
Cambridge
CB1 9NL
United Kingdom
CB1 9NL
United Kingdom
Sponsor information
MRC Human Nutrition Research (UK)
Research council
Research council
Elsie Widdowson Laboratory
Fulbourn Road
Cambridge
CB1 9NL
United Kingdom
"ROR" |
https://ror.org/050pqs331 |
|---|
Funders
Funder type
Government
Food Standards Agency (UK) (ref: N05065/N05066)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
