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Cereal nutrition for child health trial

Development of a randomised controlled trial to increase cereal fibre intake to reduce insulin resistance in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33260236
Enrollment
300
Registered
2017-08-22
Start date
2017-09-15
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of type 2 diabetes, and particularly reduction of the degree of insulin resistance Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

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

Sponsors

St George's, University of London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
1. 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

Countries

England, United Kingdom

Contacts

Public ContactPeter Whincup

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026