Plain English Summary
Background and study aims
Oily fish such as mackerel and sardines contain natural omega-3 fatty acids (O3FAs). They are commonly used as nutritional supplements in capsule form, with evidence suggesting numerous health benefits including improved cognitive performance, maintenance of a healthy heart and even possible anti-cancer effects. There is however little known about the amount of O3FA that enter an individual’s large bowel after taking O3FA capsules. This is of particular interest as O3FAs may have numerous effects on the environment within the bowel, including anti-bowel cancer effects and possible changes in the type and balance of bacteria. The aim of our study is to measure the amount of O3FAs present in the stoma fluid after taking daily O3FA capsules for 4 weeks. We will also examine how O3FAs alter the balance of bacteria within the gut.
Who can participate?
Patients aged 50 or over with a temporary ileostomy (An ileostomy is where the bowel is diverted through an opening in the tummy [stoma] to collect waste products in a bag. They are performed to allow the bowel to heal after surgery to treat bowel cancer).
What does the study involve?
Participants are required to take two O3FA gelatin capsules twice a day with meals for 4 weeks. The O3FA capsules contain naturally occurring fatty acids found in oily fish such as mackerel and sardines. They are widely available for people to buy over the counter from pharmacies and supermarkets. The amount of O3FA within the stoma fluid is measured after taking the O3FA capsules for 4 weeks. Participants provide a stoma fluid sample at three separate visits over the 4 week period. At the start and end of the study participants also provide blood samples to measure the levels of O3FAs in the blood.
What are the possible benefits and risks of participating?
Although O3FA supplementation is associated with many health benefits, taking part in this study is unlikely to directly help participants. However, the results of the study may help plan future research exploring the beneficial effects of O3FAs against bowel cancer. Participants may get some mild side-effects such as indigestion-type symptoms (including belching or change in stoma volume), at which stage they can decide whether to reduce or stop supplementation temporarily or permanently. Sometimes symptoms disappear if the daily dose is reduced. If participants stop taking the capsules during the 4 weeks, a stoma fluid sample and blood test is still required at the end of the study.
Where is the study run from?
St James University Hospital Leeds (UK)
When is the study starting and how long is it expected to run for?
October 2015 to October 2016
Who is funding the study?
Leeds Teaching Hospital Charitable Trust (UK)
Who is the main contact?
Dr Henry Watson
ugm3hsw@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark Hull
ORCID ID
http://orcid.org/0000-0001-7414-1576
Contact details
Level 9
Wellcome Trust Brenner
St James’ University
Leeds
LS97TF
United Kingdom
+44 (0)113 343 8650
M.A.Hull@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
A pilot study to measure omega-3 fatty acid levels in terminal ileal content following four weeks of omega-3 fatty acid supplementation in patients with a temporary ileostomy
Acronym
Study hypothesis
After 4 weeks of O3FA supplementation there is an increase in terminal ileal EPA and DHA levels compared with basal levels.
Ethics approval
Yorkshire & The Humber - Leeds West Research Ethics Committee, 05/01/2016, ref: 15/YH/0547
Study design
Single-centre pilot study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to requesta patient information sheet.
Condition
Participants with a loop ileostomy following anterior resection for colorectal cancer.
Intervention
All participants take two O3FA containing soft gel capsules twice daily with meals (total 1000 mg EPA and 1000 mg DHA daily) for 4 weeks. They are asked to provide a stoma fluid sample at 3 separate visits over the 4 week period. At the start and end of the study participants are also asked to provide a blood sample to measure the levels of O3FAs in their blood.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Change in terminal ileal fluid EPA and DHA concentration at four weeks compared with baseline.
Secondary outcome measures
1. Change in percentage erythrocyte membrane content of EPA and DHA at four weeks compared with baseline.
2. Change in terminal ileal fluid EPA and DHA concentration within 24 hours of taking the first O3FA dose.
3. Tolerability and adverse events related to O3FA supplementation.
Overall trial start date
01/10/2015
Overall trial end date
01/10/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 50 years or over
2. Either gender
3. Temporary ileostomy fashioned at least 2 months prior to commencing study
4. Able to self medicate
5. A minimum period of 2 months availability for the study prior to planned ileostomy reversal
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8
Participant exclusion criteria
1. Seafood allergy
2. Ongoing and/or previous use (within 4 weeks of commencing the study) of other O3FA or cod-liver oil supplements
3. Previous small bowel resection
4. Metastatic colorectal cancer
5. Less than 4 weeks since any chemotherapy or radiotherapy
6. Inflammatory bowel disease or other intestinal disease (e.g. coeliac disease)
Recruitment start date
10/02/2016
Recruitment end date
20/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St James University Hospital
Leeds
LS97TF
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Faculty Research Office
Room 10.110
Level 10
Worsley Building
Clarendon Way
Leeds
LS29NL
United Kingdom
+44 (0)113 343 7587
governance-ethics@leeds.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Leeds Teaching Hospital Charitable Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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