| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN35312139 |
| Date ISRCTN assigned | 02/08/2007 |
| Local reference number(s) | NS1 |
| Public title | Fermentation and cardiovascular risk factors |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Type 2 diabetes/ obesity |
| Study hypothesis | That consuming a fermentable carbohydrate will improve indices of insulin sensitivity in individuals with insulin resistance. |
| Design/methodology | Randomised, parallel, single-blind dietary intervention. |
| Research ethics review | Central Office of Research Ethics Committees (COREC) and the University of Surrey Ethics Committee, approved on 26th June 2006 (REC ref: O6/Q1909/30) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy
2. Fasting insulin >60 pmol/l
2. Male and female 18-60 years |
| Participants - exclusion criteria | 1. Cardiovascular or endocrine diseases
2. Medication likely to affects either lipid or glucose metabolism |
| Patient information material |
|
| Anticipated start date | 01/11/2006 |
| Anticipated end date | 30/10/2008 |
| Status of trial | Ongoing |
| Target number of participants | 45 |
| Interventions | Dietary supplementation with either 0 g, 20 g or 40 g resistant starch per day for 12 weeks. |
| Primary outcome measure(s) | Insulin sensitivity will be assessed before and after the 12-week intervention by the following:
1. Euglycaemic-hyperinsulinaemic clamp
2. Liver fat content measured by Magnetic Resonance Imaging [MRI] |
| Secondary outcome measure(s) | The following outcomes are being measured before and after the 12-week intervention:
1. Endothelial function, assessed by Pulse Wave Velocity (PWV) and 24-hour blood pressure recordings
2. Blood inflammatory markers |
| Sources of funding | National Starch and Chemical Company (International) |
| Sponsor name | University of Surrey (UK) |
| Sponsor details | Research and Enterprise Support
Nodus Centre
University of Surrey
Guildford
United Kingdom
GU2 7XH |
| Sponsor website | http://www.surrey.ac.uk/ |
| Contact name | Dr Denise Robertson |
| Contact details | Biomedical and Molecular Sciences
University of Surrey
Guildford
United Kingdom
GU2 7XH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN35312139 |
| Date last extracted from ISRCTN register | 17/04/2008 |
