Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/06/2007
Date assigned
02/08/2007
Last edited
07/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Denise Robertson

ORCID ID

Contact details

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

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

http://www.surrey.ac.uk/

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

  1. 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.

Additional files

Editorial Notes