Prebiotics and Mental Health: Behavioural

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616937
• Other study ID #: PrebioticStudy
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: November 2020
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Emotion Regulation

Intervention

Dietary Supplement:
• GOS
Prebiotic
• Placebo
Placebo

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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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