The role of resistant starch in the treatment of insulin resistance
| ISRCTN | ISRCTN56997186 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56997186 |
| Secondary identifying numbers | 6301 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 06/11/2012
- 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
Prof David Russell-Jones
Scientific
Scientific
Egerton Road
Guildford
GU2 7XX
United Kingdom
Study information
| Study design | Single centre randomised interventional prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study acronym | Resistant Starch |
| Study objectives | A randomised cross-over dietary intervention study looking at the role of an insoluble dietary fibre in the prevention of type 2 diabetes in participants with metabolic syndrome. |
| Ethics approval(s) | MREC approved on the 2nd August 2006 (ref: 06/Q1803/57) |
| Health condition(s) or problem(s) studied | Topic: Metabolic and Endocrine; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes) |
| Intervention | Participants are supplemented with either 40 g/day resistant starch (fibre) for 8 weeks compared to a placebo supplement which is energy matched. Study entry: single randomisation only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Resistant starch |
| Primary outcome measure | Insulin sensitivity measured with hyperinsulinaemic euglycaemic clamp at end of each 8 week intervention. |
| Secondary outcome measures | 1. mRNA expression in adipose tissue biopsies taken at end of each 8 week intervention 2. Postprandial meal handling and arteriovenous uptake of glucose measured at end of each 8 week intervention |
| Overall study start date | 01/11/2006 |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | Planned sample size: 15 |
| Key inclusion criteria | 1. Non-diabetic 2. No history of cardiovascular, endocrine or gastrointestinal disease 3. Male and female over the age of 18 years 4. Fasting plasma insulin greater than 60 pmol/l |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Egerton Road
Guildford
GU2 7XX
United Kingdom
GU2 7XX
United Kingdom
Sponsor information
University of Surrey (UK)
University/education
University/education
Faculty of Health and Medical Science
Guildford
GU2 7XH
England
United Kingdom
| Website | http://www2.surrey.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/00ks66431 |
Funders
Funder type
Charity
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
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 | 01/09/2012 | Yes | No |
