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

February 6, 2024 updated by: University of Surrey
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XH
        • University of Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Maltodextrin
Single 7g dose daily for 28 days
Active Comparator: Treatment
Dietary supplement: Galacto-oligosaccharide
Single 7g dose daily for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental anxiety: covariate of child outcome.
Time Frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Self report instrument: state-trait anxiety inventory (STAI) - Trait scale.
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Parental emotion processing: covariate of child outcome.
Time Frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Performance on behavioural task: emotional dot-probe task.
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Parent depression
Time Frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Self report instrument: Becks depression inventory (BDI-II).
Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Parent attention networks
Time Frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).
Performance on behavioural task: attention network test.
Baseline, End of treatment (4 weeks), Follow up (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

FrieslandCampina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • FearlessStudy4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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