Fish Feeding Study (FFS): The impact of fish and fish oil capsule intake on omega-3 fatty acid status, health and cognitive function of Omani school children of 9-10 years old living in Muscat

ISRCTN	ISRCTN93233285
DOI	https://doi.org/10.1186/ISRCTN93233285
Secondary identifying numbers	v1

Submission date: 13/07/2012
Registration date: 10/01/2013
Last edited: 24/11/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
There has been a sharp increase in obesity, type 2 diabetes, and cardio-vascular disease in Omani population. Childhood obesity is a strong precursor for adult obesity which in turn is associated with type 2 diabetes and cardio-vascular disease. Moreover, more children are affected by psychiatric disorder such as attention deficit and hyperactivity disorder. Growing evidence suggests that increased consumption of fish and marine products which are the main source of long-chain omega-3 fatty acids have beneficial effect on obesity, cardio-vascular disease and childrens learning and behaviour. In this study, we aim to (a) assess nutritional status (b) investigate the effect of omega-3 fatty acids either by eating more fish or taking omega-3 oil on the lipid profile, body fat, and cognition and behaviour of Omani children.

Who can participate?
Healthy male and female Omani school children of 9-10 years old living in Muscat, Sultanate of Oman.

What does the study involve?
Children will be asked either to eat fish meal or take one capsule of omega-3 fish oil four times a week for 16 weeks. Blood samples obtained before and after the dietary intervention will be assessed for the nutritional status, blood lipid profile, and total blood counts. Similarly, body composition, and cognition and behaviour will be assessed in all children.

What are the possible benefits and risks of participating?
Each participant (childrens parent or guardian) will receive a feedback on their overall nutritional and health status.
There is no risk of participating.

Where is the study run from?
The study has been set up by the Lipidomics and Nutrition Research Centre, Faculty of Life Sciences and Computing, London Metropolitan University in collaboration with the Ministries of Agriculture and Fisheries Wealth, Health, and Education, and Sultan Qaboos University, Sultanate of Oman. The recruitment, intervention and part of the assessment will be carried out in Muscat, Sultanate of Oman, and some of the biochemical analysis will be conducted at London Metropolitan University.

When is the study starting and how long is it expected to run for?
The study started in September 2012 and will last for two years.

Who is funding the study?
The Ministry of Agriculture and Fisheries Wealth, Sultanate of Oman has provided the funding for the study.

Who is the main contact?
Profession Kebreab Ghebremeskel
k.ghebremeskel@londonmet.ac.uk

Dr Yoeju Min
y.min@londonmet.ac.uk

Study website

Contact information

Prof Kebreab Ghebremeskel
Scientific

Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166-220 Holloway Road
London
N7 8DB
United Kingdom

Study information

Study design	Randomised open-label trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The impact of fish and fish oil capsule intake on omega-3 fatty acid status, health and cognitive function of Omani school children of 9-10 years old living in Muscat: a randomised open-label trial
Study acronym	FFS
Study objectives	Additional intake of fish or omega-3 oil capsule does not enhance blood docosahexaenoic acid (DHA) level in healthy Omani school children.
Ethics approval(s)	1. Research and Ethical Review and Approve Committee, Ministry of Health, Sultanate of Oman, 19/06/2012, ref: MH/DGP/R%S/PROPOSAL_APPROVED/8/2012 2. NRES Committee North West - Haydock, UK, 11/10/2012, REC Reference - 12/NW/0760
Health condition(s) or problem(s) studied	Nutritional status
Intervention	Fish Meal Group - Fish lunch (100-150g of fish per serving) 4 times a week Omega-3 Oil Group - One fish oil capsule which contains 200-250 mg long-chain omega-3 fatty acids 4 times a week Total duration of intervention: 16 weeks
Intervention type	Supplement
Primary outcome measure	Red blood cell docosahexaenoic acid (DHA) level at the end of 16 weeks of dietary intervention
Secondary outcome measures	1. Body fat % 2. Full blood counts 3. Blood lipid profile 4. Behaviour and cognitive functions Measured at the end of 16 weeks of dietary intervention
Overall study start date	01/09/2012
Completion date	31/08/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	9 Years
Upper age limit	10 Years
Sex	Both
Target number of participants	354
Key inclusion criteria	Male and female children aged 9-10 years who do not have any hereditary or chronic medical condition
Key exclusion criteria	Children with known hereditary or chronic medical condition which requires medication or suffer from fish or shellfish allergy
Date of first enrolment	01/09/2012
Date of final enrolment	31/08/2014

Locations

Countries of recruitment

England
Oman
United Kingdom

Study participating centre

Lipidomics and Nutrition Research Centre

London
N7 8DB
United Kingdom

Sponsor information

London Metropolitan University (UK)
University/education

Faculty of Life Sciences and Computing
166-220 Holloway Road
London
N7 8DB
England
United Kingdom

Website	http://www.londonmet.ac.uk
"ROR"	https://ror.org/00ae33288

Funders

Funder type

Government

Ministry of Agriculture and Fisheries Wealth (Oman) (Ref. No. 1/3/43)

No information available

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