Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/07/2012
Date assigned
10/01/2013
Last edited
24/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 children’s 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 (children’s 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

http://www.londonmet.ac.uk/faculties/faculty-of-life-sciences-and-computing/research/lipidomics-and-nutrition-research-centre/research-projects/current/fish-feeding-study/

Contact information

Type

Scientific

Primary contact

Prof Kebreab Ghebremeskel

ORCID ID

Contact details

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

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

http://www.londonmet.ac.uk

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

Publication citations

Additional files

Editorial Notes