Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/10/2006
Date assigned
03/01/2007
Last edited
05/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Prentice

ORCID ID

Contact details

MRC International Nutrition Group
Nutrition & Public Health Intervention Research Unit
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8125
Andrew.Prentice@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Medical Research Council Gambia SCC Project # 854

Study information

Scientific title

Acronym

Study hypothesis

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

The study was approved by the Gambia Government/MRC Joint Ethics Committee (Project # 816), approved March 2001.

Study design

Randomised double-blind control longitudinal intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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 names

n-3 cooking oil (rapeseed oil), n-6 cooking oil (sunflower oil), fish oil derived EPA/DHA capsules.

Primary outcome measures

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 trial start date

25/10/2001

Overall trial end date

08/05/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

A total of 61 participants were recruited for the trial

Participant exclusion criteria

Subjects diagnosed as diabetic by their doctor or on medication

Recruitment start date

25/10/2001

Recruitment end date

08/05/2002

Locations

Countries of recruitment

Gambia

Trial participating centre

MRC International Nutrition Group
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
grants@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Supplementary project grant to Gambia MRC Nutrition/NCD Programme

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