Measuring omega-3 fatty acid levels in terminal ileal content following four weeks of omega-3 fatty acid supplementation in patients with a temporary ileostomy

ISRCTN ISRCTN14530452
DOI https://doi.org/10.1186/ISRCTN14530452
Secondary identifying numbers 1.0
Submission date
05/02/2016
Registration date
16/02/2016
Last edited
10/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 June 2019

Who is funding the study?
Leeds Teaching Hospital Charitable Trust (UK)

Who is the main contact?
Dr Henry Watson
ugm3hsw@leeds.ac.uk

Contact information

Prof Mark Hull
Scientific

Level 9, Wellcome Trust Brenner
St James’ University
Leeds
LS9 7TF
United Kingdom

ORCiD logoORCID ID 0000-0001-7414-1576
Phone +44 (0)113 343 8650
Email M.A.Hull@leeds.ac.uk

Study information

Study designSingle-centre pilot study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to requesta patient information sheet.
Scientific titleA 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
Study objectivesAfter 4 weeks of O3FA supplementation there is an increase in terminal ileal EPA and DHA levels compared with basal levels.
Ethics approval(s)Yorkshire & The Humber - Leeds West Research Ethics Committee, 05/01/2016, ref: 15/YH/0547
Health condition(s) or problem(s) studiedParticipants with a loop ileostomy following anterior resection for colorectal cancer.
InterventionAll 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 typeSupplement
Primary outcome measureChange in terminal ileal fluid EPA and DHA concentration at four weeks compared with baseline.
Secondary outcome measures1. 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 study start date01/10/2015
Completion date30/06/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants8
Total final enrolment11
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment10/02/2016
Date of final enrolment30/12/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St James University Hospital
Leeds
LS97TF
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Faculty Research Office
Room 10.110, Level 10, Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom

Phone +44 (0)113 343 7587
Email governance-ethics@leeds.ac.uk
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Charity

Leeds Teaching Hospital Charitable Trust

No information available

Results and Publications

Intention to publish date30/06/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planCurrent publication and dissemination plan as of 09/06/2020:
Planned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Previous publication and dissemination plan:
Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 24/05/2021 27/05/2021 Yes No
Protocol file version 3 27/06/2018 10/10/2022 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN14530452_Protocol_v3_27Jun2018.pdf

Editorial Notes

10/10/2022: Protocol file uploaded.
27/05/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
09/06/2020: The following changes were made to the trial record:
1. The publication and dissemination plan was updated.
2. The participant level data was changed from Not provided at time of registration to Available on request.
24/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2018 to 30/12/2018.
2. The overall trial end date was changed from 31/07/2018 to 30/06/2019.
3. The intention to publish date was changed from 31/07/2019 to 30/06/2020.
30/10/2017: Internal review.
22/09/2017: Recruitment end date has been updated from 20/04/2016 to 30/06/2018. Overall trial end date has been updated from 01/10/2016 to 31/07/2018.
14/06/2016: Plain English summary added.