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OpenTrials
Completed

NCT Number: NCT06258135

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

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).

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Key information

Conditions

Emotional Regulation Behavior Self-Control Social Behavior

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Galacto-oligosaccharide

Dietary Supplement

Single 7g dose daily for 28 days

Maltodextrin

Dietary Supplement

Single 7g dose daily for 28 days

Primary outcomes

  1. 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.

  2. Changes in emotion processing.

    Time frame: End of treatment (4 weeks), Follow up (8 weeks).

    Performance on behavioural task: emotional dot-probe task.

Secondary outcomes

  1. Changes in depression.

    Time frame: End of treatment (4 weeks), Follow up (8 weeks).

    Self report instrument: child depression inventory (CDI).

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Parent depression

    Time frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).

    Self report instrument: Becks depression inventory (BDI-II).

  4. Parent attention networks

    Time frame: Baseline, End of treatment (4 weeks), Follow up (8 weeks).

    Performance on behavioural task: attention network test.

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Collaborators

  • FrieslandCampina

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 14, 2024
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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