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
Secondary identifying numbers	Medical Research Council Gambia SCC Project # 854

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Prentice
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
Email	Andrew.Prentice@lshtm.ac.uk

Study information

Study design	Randomised double-blind control longitudinal intervention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
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
Pharmaceutical study type(s)
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	Outcomes were measured before baseline, at baseline, at three and six months of the intervention: 1. Full plasma and adipose tissue fatty acid analysis 2. Fasting glucose 3. Fasting insulin 4. Oral glucose tolerance test
Secondary outcome measures	1. Anthropometric measurements (fat mass and fat free mass, waist-to-hip ratio) 2. Diastolic and systolic blood pressure 3. Full lipid profile 4. Plasma Tumour Necrosis Factor (TNF)alpha and receptors 5. Plasma InterLeukin-6 (IL-6) and receptors 6. Sialic acid
Overall study start date	25/10/2001
Completion date	08/05/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	A total of 61 participants were recruited for the trial
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

England
Gambia
United Kingdom

Study participating centre

MRC International Nutrition Group

London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	grants@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk
"ROR"	https://ror.org/03x94j517

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Supplementary project grant to Gambia MRC Nutrition/NCD Programme

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

Editorial Notes

03/12/2019: No publications found, verifying study status with principal investigator.