Pilot study on the effect of different dietary fatty acids on impaired glucose tolerance in obese urban Gambian women
| ISRCTN | ISRCTN24376821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24376821 |
| Protocol serial number | Medical Research Council Gambia SCC Project # 854 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funders | Medical Research Council (UK), Supplementary project grant to Gambia MRC Nutrition/NCD Programme |
- Submission date
- 23/10/2006
- Registration date
- 03/01/2007
- Last edited
- 03/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
MRC International Nutrition Group
Nutrition & Public Health Intervention Research Unit
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7958 8125 |
|---|---|
| Andrew.Prentice@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind control longitudinal intervention trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pilot study on the effect of different dietary fatty acids on impaired glucose tolerance in obese urban Gambian women |
| Study objectives | Whether modifying the ratio n-3:n-6 polyunsaturated fatty acid dietary intake could prevent deterioration of impaired glucose tolerance in obese Gambian women. |
| Ethics approval(s) | The study was approved by the Gambia Government/MRC Joint Ethics Committee (Project # 816), approved March 2001. |
| Health condition(s) or problem(s) studied | Obesity-related disease, non-insulin dependent diabetes mellitus |
| Intervention | Intervention group: High n-3 cooking oil (rapeseed oil) plus fish oil derived EPA/DHA capsules (3 g daily) Control group: High n-6 cooking oil (sunflower oil) plus placebo corn oil capsules (3 g daily) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | n-3 cooking oil (rapeseed oil), n-6 cooking oil (sunflower oil), fish oil derived EPA/DHA capsules. |
| Primary outcome measure(s) |
Outcomes were measured before baseline, at baseline, at three and six months of the intervention: |
| Key secondary outcome measure(s) |
1. Anthropometric measurements (fat mass and fat free mass, waist-to-hip ratio) |
| Completion date | 08/05/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 61 |
| Key inclusion criteria | 1. Female living in Bakau (urban area in the Gambia) 2. Aged 30 years or older 3. Being obese i.e. having a body mass index more than or equal to 27 kg/m^2 4. Having an impaired glucose tolerance (oral glucose tolerance test; 120-minute glucose between 6.7 and 10.0 mmol/l) 5. Subjects consent |
| Key exclusion criteria | Subjects diagnosed as diabetic by their doctor or on medication |
| Date of first enrolment | 25/10/2001 |
| Date of final enrolment | 08/05/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
- Gambia
Study participating centre
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
03/12/2019: No publications found, verifying study status with principal investigator.
