Cognition, Emotion Regulation, Sleep, Temperament
Conditions
Keywords
prebiotics, emotion regulation, gut microbiome diversity, children, relative abundance, sleep, internalising symptoms, externalising symptoms
Brief summary
This study aims to investigate the chronic effects of prebiotic consumption on cognitive, behavioural and gut microbiome outcomes in children aged 3-5 years.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic powder
5g of prebiotic fibre
DIETARY_SUPPLEMENTPlacebo
5g of placebo
Sponsors
University of Reading
Beneo GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Parents (18 years and over) of generally healthy children aged 3-5-years-old (36-71 months) with lower dietary fibre intake than the recommended daily amount (10.4g/day in 18-47-month-olds and less than 12.6g/day in 48-60-month-olds).
Exclusion criteria
* Children with a significant acute or chronic co-existing illness (including inflammatory bowel disease, functional gastrointestinal disorders, coeliac disease etc, neurodevelopmental, immunological, psychiatric, or metabolic disorders. * Children who have taken any pre/probiotic supplements or antibiotic treatment within the 4 weeks prior to enrolment. * Children with food allergies and intolerances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Behaviour Checklist Ages 1.5-5 | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) | Parents will be asked to complete this validated measure that includes 100 items that assesses a child's emotional, behavioral, and social problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotion Regulation Skills Questionnaire | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) | Parents will be asked to complete this measure that includes 52 items that assesses a child's adaptive and maladaptive emotion regulation skills. |
| Childhood Autism Spectrum Test | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) | Parents will be asked to complete this measure that includes 44 items that assesses a child's developmental differences in social and communication functioning |
| Bristol Stool Chart | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) | Parents will be asked to complete this measure that includes 1 item that assesses a child's stool consistency. |
| Gut microbiome diversity | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). | Children's stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing). |
| Gut microbiome composition | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). | Children's stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing). |
Countries
United Kingdom
Contacts
CONTACTPiril Hepsomali, PhD
Outcome results
None listed