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

Not Applicable

Completed

• Conditions: Emotional Regulation
• Interventions: Dietary Supplement: Galacto-oligosaccharide; Dietary Supplement: Maltodextrin

• Registration Number: NCT06258135
• Lead Sponsor: University of Surrey

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Galacto-oligosaccharide	-
Placebo	Maltodextrin	-

Primary Outcome Measures

Name	Time	Method
Changes in emotion processing.	End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: emotional dot-probe task.
Changes in trait anxiety.	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.

Secondary Outcome Measures

Name	Time	Method
Changes in depression.	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: child depression inventory (CDI).
Changes in nutrient intake	End of treatment (4 weeks), Follow up (8 weeks).	Self report instrument: food diary completed over 4 days, average intakes calculated.
Changes in attention networks.	End of treatment (4 weeks), Follow up (8 weeks).	Performance on behavioural task: attention network test (ANT) adapted for use by children.

Trial Locations

Locations (1)

University of Surrey; 🇬🇧 Guildford, Surrey, United Kingdom