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| [ Print-friendly version ] |
| 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 | 10.1186/ISRCTN93233285 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | 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 |
| 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 |
| Serial number at source | v1 |
| Study hypothesis |
Additional intake of fish or omega-3 oil capsule does not enhance blood docosahexaenoic acid (DHA) level in healthy Omani school children.
Trial website: http://www.londonmet.ac.uk/depts/fls/hhs/research/lnrc/research-projects/effect-of-fish-feeding-on-obesegenic-markers-and-cognitive-function-in-omani-schoolchildren.cfm |
| Lay 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 |
| Ethics approval |
1. Research and Ethical Review and Approve Committee, Ministry of Health, Sultanate of Oman, 19 June 2012, ref: MH/DGP/R%S/PROPOSAL_APPROVED/8/2012
2. NRES Committee North West – Haydock, UK, 11 October 2012, REC Reference - 12/NW/0760 |
| Study design | Randomised open-label trial |
| Countries of recruitment | Oman |
| Disease/condition/study domain | Nutritional status |
| Participants - inclusion criteria | Male and female children aged 9-10 years who do not have any hereditary or chronic medical condition |
| Participants - exclusion criteria | Children with known hereditary or chronic medical condition which requires medication or suffer from fish or shellfish allergy |
| Anticipated start date | 01/09/2012 |
| Anticipated end date | 31/08/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 354 |
| Interventions |
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 |
| Primary outcome measure(s) | Red blood cell docosahexaenoic acid (DHA) level at the end of 16 weeks of dietary intervention |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Ministry of Agriculture and Fisheries Wealth (Oman) (Ref. No. 1/3/43) |
| Trial website | |
| Publications | |
| Contact name | Prof Kebreab Ghebremeskel |
| Address |
Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing London Metropolitan University 166-220 Holloway Road |
| City/town | London |
| Zip/Postcode | N7 8DB |
| Country | United Kingdom |
| Sponsor | London Metropolitan University (UK) |
| Address |
Faculty of Life Sciences and Computing
166-220 Holloway Road |
| City/town | London |
| Zip/Postcode | N7 8DB |
| Country | United Kingdom |
| Sponsor website: | http://www.londonmet.ac.uk |
| Date applied | 13/07/2012 |
| Last edited | 10/01/2013 |
| Date ISRCTN assigned | 10/01/2013 |
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