Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1
Study information
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
Acronym
FFS
Study hypothesis
Additional intake of fish or omega-3 oil capsule does not enhance blood docosahexaenoic acid (DHA) level in healthy Omani school children.
Ethics approval
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
Study design
Randomised open-label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/09/2012
Overall trial end date
31/08/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Male and female children aged 9-10 years who do not have any hereditary or chronic medical condition
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
354
Participant exclusion criteria
Children with known hereditary or chronic medical condition which requires medication or suffer from fish or shellfish allergy
Recruitment start date
01/09/2012
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Oman
Trial participating centre
Lipidomics and Nutrition Research Centre
London
N7 8DB
United Kingdom
Sponsor information
Organisation
London Metropolitan University (UK)
Sponsor details
Faculty of Life Sciences and Computing
166-220 Holloway Road
London
N7 8DB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Ministry of Agriculture and Fisheries Wealth (Oman) (Ref. No. 1/3/43)
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