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ISRCTN
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ISRCTN35312139
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ClinicalTrials.gov identifier
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Public title
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Fermentation and cardiovascular risk factors
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Scientific title
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Acronym
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N/A
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Serial number at source
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NS1
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Study hypothesis
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That consuming a fermentable carbohydrate will improve indices of insulin sensitivity in individuals with insulin resistance.
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Ethics approval
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Central Office of Research Ethics Committees (COREC) and the University of Surrey Ethics Committee, approved on 26th June 2006 (REC ref: O6/Q1909/30)
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Study design
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Randomised, parallel, single-blind dietary intervention.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Type 2 diabetes/ obesity
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Participants - inclusion criteria
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1. Healthy
2. Fasting insulin >60 pmol/l
2. Male and female 18-60 years
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Participants - exclusion criteria
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1. Cardiovascular or endocrine diseases
2. Medication likely to affects either lipid or glucose metabolism
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Anticipated start date
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01/11/2006
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Anticipated end date
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30/10/2008
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Status of trial
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Completed
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Patient information material
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Target number of participants
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45
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Interventions
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Dietary supplementation with either 0 g, 20 g or 40 g resistant starch per day for 12 weeks.
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Primary outcome measure(s)
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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]
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Secondary outcome measure(s)
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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
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Sources of funding
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National Starch and Chemical Company (International)
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Trial website
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Publications
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Contact name
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Dr
Denise
Robertson
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Address
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Biomedical and Molecular Sciences
University of Surrey
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City/town
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Guildford
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Zip/Postcode
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GU2 7XH
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Country
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United Kingdom
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Sponsor
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University of Surrey (UK)
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Address
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Research and Enterprise Support
Nodus Centre
University of Surrey
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City/town
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Guildford
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Zip/Postcode
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GU2 7XH
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Country
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United Kingdom
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Sponsor website:
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http://www.surrey.ac.uk/
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Date applied
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07/06/2007
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Last edited
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02/08/2007
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Date ISRCTN assigned
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02/08/2007
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