This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
This study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 8-week-long prebiotic consumption on cognitive, behavioural, and gut microbiome, outcomes in 3-5-year-old children with insufficient fibre intake (less than the average 10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds). One hundred and six participants will be randomised to Intervention or Placebo groups where they will be consuming 5g of prebiotic fibre or 5g of placebo (matched placebo powder) per day for 8-weeks. Outcome measures will be acquired before and after a 8-week chronic supplementation. These will include cognitive and behavioural outcomes of the parents and children. In addition, stool samples will be collected at the baseline and at week 8 to assess microbiome diversity and composition. Additionally, after 4-weeks of wash-out, at 12 weeks, parents will be asked to completed online questionnaires assessing cognitive and behavioural outcome of their children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
106
5g of prebiotic fibre
5g of placebo
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, United Kingdom
Child Behaviour Checklist Ages 1.5-5
Parents will be asked to complete this validated measure that includes 100 items that assesses a child's emotional, behavioral, and social problems.
Time frame: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)
Emotion Regulation Skills Questionnaire
Parents will be asked to complete this measure that includes 52 items that assesses a child's adaptive and maladaptive emotion regulation skills.
Time frame: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)
Childhood Autism Spectrum Test
Parents will be asked to complete this measure that includes 44 items that assesses a child's developmental differences in social and communication functioning
Time frame: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)
Bristol Stool Chart
Parents will be asked to complete this measure that includes 1 item that assesses a child's stool consistency.
Time frame: This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out)
Gut microbiome diversity
Children's stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).
Gut microbiome composition
Children's stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
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Time frame: This measure will be taken at baseline (pre intervention) and week 8 (post intervention).