At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).

Emotional Regulation Clinical Trial

Official title:

At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06258135
• Other study ID #: FearlessStudy4
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2024
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• Typically developing, healthy male or female aged 6-14 years

• Access to home laptop/ personal computer

Exclusion Criteria:

• Current clinical levels of anxiety and/or co-morbid psychological diagnoses

• Neuro/developmental disorders

• Gastro-intestinal problems or disease

• Restrictive diets (e.g., lactose intolerance, gluten free)

Related Conditions & MeSH terms

• Emotional Regulation

Intervention

Dietary Supplement:
• Galacto-oligosaccharide
Single 7g dose daily for 28 days
• Maltodextrin
Single 7g dose daily for 28 days

Locations

Country	Name	City	State
United Kingdom	University of Surrey	Guildford	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	FrieslandCampina

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Parental anxiety: covariate of child outcome.	Self report instrument: state-trait anxiety inventory (STAI) - Trait scale.	Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Other	Parental emotion processing: covariate of child outcome.	Performance on behavioural task: emotional dot-probe task.	Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Other	Parent depression	Self report instrument: Becks depression inventory (BDI-II).	Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Other	Parent attention networks	Performance on behavioural task: attention network test.	Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Primary	Changes in trait anxiety.	Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.	End of treatment (4 weeks), Follow up (8 weeks).
Primary	Changes in emotion processing.	Performance on behavioural task: emotional dot-probe task.	End of treatment (4 weeks), Follow up (8 weeks).
Secondary	Changes in depression.	Self report instrument: child depression inventory (CDI).	End of treatment (4 weeks), Follow up (8 weeks).
Secondary	Changes in attention networks.	Performance on behavioural task: attention network test (ANT) adapted for use by children.	End of treatment (4 weeks), Follow up (8 weeks).
Secondary	Changes in nutrient intake	Self report instrument: food diary completed over 4 days, average intakes calculated.	End of treatment (4 weeks), Follow up (8 weeks).