Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beneo GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic (powder) | Experimental | Children will consume two (one in the morning and one in the evening) 2.5g of prebiotic sachets a day (mixed with food and drink). |
|
| Matched placebo (powder) | Placebo Comparator | Children will consume two (one in the morning and one in the evening) 2.5g of placebo sachets a day (mixed with food and drink). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prebiotic powder | Dietary Supplement | 5g of prebiotic fibre |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This measure will be taken at baseline (pre intervention), week 8 (post intervention) and week 12 (after 4-week wash-out) |
| Measure | Description | Time Frame |
|---|---|---|
| Attentional Control Scale | Parents will be asked to complete this measure that includes 20 items that assesses their own attentional control. | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
| Difficulties in Emotional Regulation Scale |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piril Hepsomali, PhD | Contact | +44 118 378 5818 | p.hepsomali@reading.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading, School of Psychology and Clinical Languages | Recruiting | Reading | Berkshire | RG6 6BZ | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
5g of placebo |
|
| 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 |
| 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. | 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). | 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). | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
Parents will be asked to complete this measure that includes 36 items that assesses their own emotion regulation skills. |
| This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
| Patient Health Questionnaire-8 | Parents will be asked to complete this measure that includes 8 items that assesses their own depressed mood. | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
| Generalised Anxiety Disorder-7 | Parents will be asked to complete this measure that includes 7 items that assesses their own anxious mood. | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
| Child-Parent Relationship Scale | Parents will be asked to complete this measure that includes 30 items that assesses their relationship with their child/children. | This measure will be taken at baseline (pre intervention) and week 8 (post intervention). |
| Scottish Collaborative Group Child VC2 Food Frequency Questionnaire | Parents will be asked to complete this measure that assesses their child's habitual food intake. | This measure will be taken at baseline (pre intervention). |
| Child Eating Behaviour Questionnaire | Parents will be asked to complete this measure that assesses their child's eating behaviour. | This measure will be taken at baseline (pre intervention). |
| Dietary recall | This measure will be used to screen participants. Parents will be asked to complete this measure that assesses their child's food intake. 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) will be eligible for the study. | This measure will be taken during screening and at week 8 (post intervention). |