Fermentation and cardiovascular risk factors
| ISRCTN | ISRCTN35312139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35312139 |
| Secondary identifying numbers | NS1 |
- Submission date
- 07/06/2007
- Registration date
- 02/08/2007
- Last edited
- 07/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Denise Robertson
Scientific
Scientific
Biomedical and Molecular Sciences
University of Surrey
Guildford
GU2 7XH
United Kingdom
Study information
| Study design | Randomised, parallel, single-blind dietary intervention. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | That consuming a fermentable carbohydrate will improve indices of insulin sensitivity in individuals with insulin resistance. |
| Ethics approval(s) | Central Office of Research Ethics Committees (COREC) and the University of Surrey Ethics Committee, approved on 26th June 2006 (REC ref: O6/Q1909/30) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | resistant starch |
| Primary outcome measure | 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 study start date | 01/11/2006 |
| Completion date | 30/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 1. Healthy 2. Fasting insulin >60 pmol/l 2. Male and female 18-60 years |
| Key exclusion criteria | 1. Cardiovascular or endocrine diseases 2. Medication likely to affects either lipid or glucose metabolism |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 30/10/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Biomedical and Molecular Sciences
Guildford
GU2 7XH
United Kingdom
GU2 7XH
United Kingdom
Sponsor information
University of Surrey (UK)
University/education
University/education
Research and Enterprise Support
Nodus Centre
University of Surrey
Guildford
GU2 7XH
England
United Kingdom
| Website | http://www.surrey.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00ks66431 |
Funders
Funder type
Industry
National Starch and Chemical Company (International)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
