Fermentation and cardiovascular risk factors

ISRCTN	ISRCTN35312139
DOI	https://doi.org/10.1186/ISRCTN35312139
Protocol serial number	NS1
Sponsor	University of Surrey (UK)
Funder	National Starch and Chemical Company (International)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Denise Robertson
Scientific

Biomedical and Molecular Sciences
University of Surrey
Guildford
GU2 7XH
United Kingdom

Primary study design	Interventional
Study design	Randomised, parallel, single-blind dietary intervention.
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	resistant starch
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]
Key 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
Completion date	30/10/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	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

Biomedical and Molecular Sciences

Guildford
GU2 7XH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes