Cereal nutrition for child health trial
| ISRCTN | ISRCTN33260236 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33260236 |
| Protocol serial number | 1.3 |
| Sponsor | St George's, University of London |
| Funder | Wellcome Trust |
- 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
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
Scientific
Population Health Research Institute
St George’s, University of London
London
SW17 0RE
United Kingdom
Public
Population Health Research Institute
St George’s, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre parallel-group randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Development of a randomised controlled trial to increase cereal fibre intake to reduce insulin resistance in children |
| Study acronym | CRUNCH |
| Study objectives | This 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) studied | Prevention of type 2 diabetes, and particularly reduction of the degree of insulin resistance |
| Intervention | Participants 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 type | Other |
| Primary outcome measure(s) |
Cereal 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 |
| Key secondary outcome measure(s) |
1. Weight and fat mass index, assessed by bioelectrical impedance at baseline and one month |
| Completion date | 30/12/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 9 Years |
| Upper age limit | 10 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 272 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 15/09/2017 |
| Date of final enrolment | 20/07/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Cranmer Terrace
London
SW17 0RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.2 | 28/02/2017 | 03/10/2022 | No | No |
Additional files
- ISRCTN33260236 Protocol v1.2 28Feb2017.pdf
- Protocol file
Editorial Notes
03/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
10/12/2020: Publication reference and total final enrolment added.
