Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NS1
Study information
Scientific title
Acronym
Study hypothesis
That consuming a fermentable carbohydrate will improve indices of insulin sensitivity in individuals with insulin resistance.
Ethics approval
Central Office of Research Ethics Committees (COREC) and the University of Surrey Ethics Committee, approved on 26th June 2006 (REC ref: O6/Q1909/30)
Study design
Randomised, parallel, single-blind dietary intervention.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Type 2 diabetes/ obesity
Intervention
Dietary supplementation with either 0 g, 20 g or 40 g resistant starch per day for 12 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
resistant starch
Primary outcome measures
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 measures
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
Overall trial start date
01/11/2006
Overall trial end date
30/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy
2. Fasting insulin >60 pmol/l
2. Male and female 18-60 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant exclusion criteria
1. Cardiovascular or endocrine diseases
2. Medication likely to affects either lipid or glucose metabolism
Recruitment start date
01/11/2006
Recruitment end date
30/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Biomedical and Molecular Sciences
Guildford
GU2 7XH
United Kingdom
Sponsor information
Organisation
University of Surrey (UK)
Sponsor details
Research and Enterprise Support
Nodus Centre
University of Surrey
Guildford
GU2 7XH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
National Starch and Chemical Company (International)
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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20536509
Publication citations
-
Results
Johnston KL, Thomas EL, Bell JD, Frost GS, Robertson MD, Resistant starch improves insulin sensitivity in metabolic syndrome., Diabet. Med., 2010, 27, 4, 391-397, doi: 10.1111/j.1464-5491.2010.02923.x.