ISRCTN ISRCTN33260236
DOI https://doi.org/10.1186/ISRCTN33260236
Secondary identifying numbers 1.3
Submission date
21/08/2017
Registration date
22/08/2017
Last edited
03/10/2022
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

Background and study aims
Type 2 diabetes is a major public health problem both worldwide and in the UK. There has been a rapid increase in the risk of type 2 diabetes in the UK over the last 30 years, suggesting that the condition is substantially preventable. An important feature of the recent type 2 diabetes epidemic has been the occurrence of type 2 diabetes in young people, which is preceded by the development of insulin resistance, when the body tissues respond poorly to circulating insulin. Dietary factors may well be important causes of type 2 diabetes, but this remains uncertain. There is evidence from a range of studies that a low intake of fibre from cereals may increase the risk of type 2 diabetes, although this remains unproven. There is a strong scientific case for establishing whether increasing cereal fibre intake can reduce insulin resistance in children. The aim of this study is to test whether providing children with high fibre cereal with support and encouragement can lead to an increase in cereal fibre intake.

Who can participate?
Pupils (boys and girls) attending London primary schools and aged 9-10, who currently eat a low fibre breakfast cereal but who find high fibre cereals palatable

What does the study involve?
Participating children are randomly allocate to receive a one-month supply of a breakfast cereal containing either high or low amounts of fibre. Encouragement and support are provided during the one-month period. They have a detailed assessment (weight and height measurements, dietary questionnaires, fasting blood sample) at the beginning and the end of the study.

What are the possible benefits and risks of participating?
There are no certain benefits or risks from participation. It is possible that children in the high fibre group will have slightly lower insulin resistance at the end of the study. No side effects are expected and all study procedures are classified as minimal risk.

Where is the study run from?
The study is based at St George’s, University of London, which is the lead and only research centre in this investigation. The recruitment of participants takes place through London primary schools.

When is the study starting and how long is it expected to run for?
January 2017 to December 2018

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Dr Angela Donin

Contact information

Dr Angela Donin
Scientific

Population Health Research Institute
St George’s, University of London
London
SW17 0RE
United Kingdom

Prof Peter Whincup
Public

Population Health Research Institute
St George’s, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Study information

Study designSingle-centre parallel-group randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleDevelopment of a randomised controlled trial to increase cereal fibre intake to reduce insulin resistance in children
Study acronymCRUNCH
Study objectivesThis study will examine whether a school-based intervention aiming to increase average cereal fibre intake in 9-10 year-old children increases it by at least 2.5 grams per day at the end of a one month intervention period.
Ethics approval(s)St. George’s Research Ethics Committee, 21/03/2017, ref: SGREC17.0007
Health condition(s) or problem(s) studiedPrevention of type 2 diabetes, and particularly reduction of the degree of insulin resistance
InterventionParticipants will be recruited through London primary schools and randomised to the intervention group or the control group.

1. Participants in the intervention group will be provided with a free one-month supply of high fibre breakfast cereal in plain packaging (high fibre = at least 3.5 grams per portion) and encouraged to consume one portion daily at breakfast. Verbal and written instructions will be provided. Research team members will visit the school regularly to provide encouragement and support.
2. Participants in the control group will be provided with a free one-month supply of low fibre breakfast cereal in plain packaging (low fibre = less than 1.0 grams per portion) and encouraged to consume one portion daily at breakfast. Verbal and written instructions will be provided. Research team members will visit the school regularly to provide encouragement and support.

Participants will have a detailed assessment (weight and height measurements, dietary questionnaires, fasting blood sample) at the beginning and the end of the one-month intervention period. All outcome measures will be assessed without knowledge of the participant's intervention status.
Intervention typeOther
Primary outcome measureCereal fibre intake during the one-month intervention period, measured using a blood-based biomarker (plasma alkyl-resorcinol) and by dietary assessment (including a multiple pass 24 hour dietary recall and a food frequency questionnaire) at baseline and one month
Secondary outcome measures1. Weight and fat mass index, assessed by bioelectrical impedance at baseline and one month
2. The acceptability of the intervention, assessed by questionnaire at one month
Overall study start date01/01/2017
Completion date30/12/2018

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit9 Years
Upper age limit10 Years
SexBoth
Target number of participants300
Total final enrolment272
Key inclusion criteria1. Children aged 9-10 years old attending London primary schools
2. No history of diabetes
3. Currently eating a breakfast cereal with low fibre content (≤1 gram of fibre per portion)
4. Able and willing to consume at least one of the high-fibre cereals being used in the trial
5. Able and willing to complete trial entry assessment (including providing a fasting blood sample)
Key exclusion criteria1. Outside the relevant age group
2. A history of diabetes
3. Not currently eating a breakfast cereal with low fibre content (≤1 gram of fibre per portion)
4. Not able and willing to consume at least one of the high-fibre cereals being used in the trial
5. Not able and willing to complete trial entry assessment (including providing a fasting blood sample)
Date of first enrolment15/09/2017
Date of final enrolment20/07/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Georges, University of London
Population Health Research Institute
Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor information

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date30/12/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planA website will be established for the study; the study protocol will be made available online on the study website in due course.

Key results from this preliminary fidelity trial will be submitted for publication in an appropriate peer-reviewed journal in the year following the trial end date.
IPD sharing planThe data sharing plans for the current study are still to be finalized and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2021 10/12/2020 Yes No
Protocol file version 1.2 28/02/2017 03/10/2022 No No

Additional files

ISRCTN33260236 Protocol v1.2 28Feb2017.pdf

Editorial Notes

03/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
10/12/2020: Publication reference and total final enrolment added.