Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
06/11/2012
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

Prof David Russell-Jones

ORCID ID

Contact details

Egerton Road
Guildford
GU2 7XX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6301

Study information

Scientific title

Acronym

Resistant Starch

Study hypothesis

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

MREC approved on the 2nd August 2006 (ref: 06/Q1803/57)

Study design

Single centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Resistant starch

Primary outcome measures

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 trial start date

01/11/2006

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 15

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2006

Recruitment end date

01/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Egerton Road
Guildford
GU2 7XX
United Kingdom

Sponsor information

Organisation

University of Surrey (UK)

Sponsor details

Faculty of Health and Medical Science
Guildford
GU2 7XH
United Kingdom

Sponsor type

University/education

Website

http://www2.surrey.ac.uk/

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22745235

Publication citations

  1. Results

    Robertson MD, Wright JW, Loizon E, Debard C, Vidal H, Shojaee-Moradie F, Russell-Jones D, Umpleby AM, Insulin-sensitizing effects on muscle and adipose tissue after dietary fiber intake in men and women with metabolic syndrome., J. Clin. Endocrinol. Metab., 2012, 97, 9, 3326-3332, doi: 10.1210/jc.2012-1513.

Additional files

Editorial Notes