Prebiotics and Mental Health: Behavioural

The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health: Behavioural

A behavioural study of the microbiota-gut-brain axis in brain development and mental health

Study Overview

• Status: Completed
• Conditions: Anxiety; Emotion Regulation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: GOS

Detailed Description

Research suggests that modifying microbial ecology therapeutically via the intake of so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and depression (Burnet & Cowen, 2013; Dinan, Stanton, & Cryan, 2013; Tang, Reddy, & Saier, 2014). The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al., 2015). They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo. Moreover, participants exhibited decreased attentional vigilance to negative information in a dot-probe task. Given that anxious people show increased biases towards negative information (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, & van, 2007), this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms.

These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut microbiota a sample of 60 undergraduate students (aged 18-25 years).

At time 1 (pre-assessment), participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being (such as anxiety levels) and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo over the same period. At time 2 (post-assessment), both groups will again undergo cognitive and psychological testing and stool sampling.

Hypothesis: It is predicted that the treatment group (GOS) will show improvements in behavioural indices of emotion regulation (e.g. dot probe task) and in self reported psychological measures related to emotion regulation (e.g. anxiety) in comparison to the placebo group. Changes/differences in gut microbiome samples will be explored.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females
• Aged between 18-25

Exclusion Criteria:

• Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
• Current or previous neurological disorders
• Current or previous psychiatric disorders
• Current or previous gastrointestinal disorders
• Current or previous endocrine disorders
• Antibiotic use 3 months prior to the study
• Regular use of pre- and probiotics, including 3 months prior to the study
• Vegan diets
• BMI >30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Galacto-oligosaccharides (GOS) Group; Daily dose of GOS over 4 weeks	Dietary supplement: GOS; Prebiotic
Placebo Comparator: Placebo group; Daily dose of maltodextrin over 4 weeks	Dietary supplement: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioural indices of emotion regulation	Changes in performance on dot-probe task measured as attentional bias to emotional stimuli in milliseconds in the prebiotic group compared to placebo. Increased attentional bias to positive stimuli and/or decreased attentional bias to negative stimuli is the desired outcome.	4 weeks
Changes in self reported indices of anxiety.	Changes in self reported anxiety as measured by the Trait Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.	4 weeks
Changes in self reported indices of anxiety 2.	Changes in self reported anxiety as measured by the State Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.	4 weeks
Changes in self reported indices of anxiety 3.	Changes in self reported social anxiety measured by Social Anxiety Scales (La G reca 1999) in the prebiotic group compared to placebo group. For this scale, a lower overall score is the desired outcome.	4 weeks
Changes in self reported emotion regulation (Thought control ability).	Changes in the prebiotic group compared to placebo for Thought control ability (Luciano et al 2005). For this questionnaire, a higher overall score is the desired outcome.	4 weeks
Changes in self reported emotion regulation (Emotion regulation strategies).	Changes in the prebiotic group compared to placebo for emotion regulation strategies (Gross & John, 2003). For this questionnaire, a higher overall score is the desired outcome.	4 weeks
Changes in self reported mood	Changes in the prebiotic group compared to placebo for mood and feelings as measured by the mood and feelings questionnaire (Angold etal., 1995). A lower overall score is the desired outcome.	4 weeks
Changes in self reported depression.	Changes in the prebiotic group compared to placebo for depression as measured by the Depression inventory (Beck & Steer, 1984). A lower score is the desired outcome.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota changes	Changes in gut microbiome composition in diversity, or in abundance of genera (%) (e.g. Bifidobacterium) from pre to post assessment in prebiotic group compared to placebo OR between prebiotic and placebo groups at post assessment.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Changes in nutrient intake and food choice	Changes in the prebiotic group compared to placebo in nutrient intake and food choice, measured by self-reported food diaries (recorded daily and averaged over 4 days at each testing point) followed by macro- and micronutrient intake analysis.	4 weeks

Collaborators and Investigators

• Sponsor: University of Surrey
• Collaborators: FrieslandCampina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PrebioticStudy

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