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Trial record 47 of 575 for:    maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03835468
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
FrieslandCampina
Information provided by (Responsible Party):
Katherin Cohen-Kadosh, University of Surrey

Brief Summary:
The role of the microbiota-gut-brain axis in brain development and mental health

Condition or disease Intervention/treatment Phase
Gamma-Aminobutyric Acid Anxiety Glutamate Emotion Regulation Abilities Dietary Supplement: Galacto-oligosaccharides Dietary Supplement: Maltodextrin Not Applicable

Detailed Description:

Anxiety disorders are debilitating conditions that carry enormous individual, social and economic costs. For example, it has been estimated that lifelong persistent mental health problems cost the UK taxpayer £8.6 billion annually. Many mental health problems have their onset in the transitional period from adolescence to early adulthood, possibly a result of the complex and concurrent hormonal, genetic, brain maturational and social changes during this period. Research has shown that brain development and maturation extends well into the third decade of life and that brain activation patterns in late adolescence and early adulthood still differ significantly from mature adults. In the recent years, the microbiome has emerged as a new and important factor that may increase the mental health risk for an individual. The intestine and the brain are intimately connected via the gut-brain axis, which involves bidirectional communication via neural, endocrine and immune pathways. Research in both the human and animal models has also highlighted the important role that intestinal microbiota play in regulating the brain, subsequent behaviour, and particularly in anxiety-like behaviour. Most importantly, it has been shown that the period of adolescence may be a critical window during development where microbiota help fine-tune the gut-brain axis related to stress responses and anxiety.

The research proposed here will investigate the role of the microbiota-gut-brain axis in brain development and mental health. Specifically, the researchers will investigate the effect of prebiotic intake on mental health and well-being in late adolescence/early adulthood, with a particular focus on cortical excitability and connectivity in the emotion regulation brain network.

This research will extend previous research into gut-brain interactions into the final years of adolescence. The period of adolescence is not only important with regards to fine-tuning emotion regulation networks, but also, as has been shown in recent work, critical for establishing healthy gut-brain communication patterns. Specifically, here we will investigate how prebiotic intake (Galacto-oligosaccharides) for 4 weeks affects cognitive functioning, psychological well-being and the underlying brain networks in a sample of 120 female undergraduate students (aged 18-25 years). Specifically, the proposed research has two main aims:

  1. To investigate how prebiotic intake affects cortical excitability and plasticity, such as inhibitory GABA/ excitatory glutamate levels in key emotion regulation brain networks.
  2. To investigate how prebiotic intake affects psychological functioning and well-being, in particular with regards to anxiety and thought control abilities.

120 participants will be divided into two group of 60 participants, groups will be matched for age, handedness and socio-economic status. At each testing time (Time 1, 2 and 3), 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).

Each participant will also be asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome at both testing times. Group 1 will receive a daily dosage of GOS over 4 weeks, whereas group 2 will receive a placebo over the same period. In addition, participants from either group will also participate in a brain imaging session to assess the effect of prebiotic supplement intake on the functional responsiveness of emotion regulation brain networks.

For this study, The researchers predict that the intervention group will show improvements in behavioural and psychological variables related to emotion regulation and anxiety in comparison to the placebo group (Hypothesis 1). Predictions also expect to observe decreased excitability in core emotion regulation brain regions such as the amygdala and prefrontal cortex, as assessed via 1H-magnet resonance spectroscopy (Hypothesis 2).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned into two groups. Group 1 will receive a daily dosage of GOS over 4 weeks, whereas group 2 will receive a placebo over the same period.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Galacto-oligosaccharides (GOS) Group
Participants in this group will receive the daily dosage of galacto-oligosaccharides (GOS) prebiotic for 4 weeks
Dietary Supplement: Galacto-oligosaccharides
GOS is a form of prebiotic, which enhance the growth of beneficial gut bacteria
Other Name: GOS

Placebo Comparator: Maltodextrin Group
Participants in this group will receive the daily dosage of Maltodextrin placebo for 4 weeks
Dietary Supplement: Maltodextrin
sugar based placebo




Primary Outcome Measures :
  1. Changes in brain indices of emotion regulation abilities as a function of prebiotic intake 1 [ Time Frame: 4 weeks of intervention ]
    Increase in brain-based metabolite concentrations (gamma-aminobutyric acid (GABA)) as assessed via Magnetic resonance spectroscopy in the prebiotics group in comparison to the placebo group.

  2. Changes in brain indices of emotion regulation abilities as a function of prebiotic intake 2 [ Time Frame: 4 weeks of intervention ]
    Increase in functional connectivity in brain networks supporting emotion regulation abilities (as assessed via functional magnetic resonance imaging) in the prebiotics group in comparison to the placebo group.

  3. Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 1 [ Time Frame: 4 weeks of intervention ]
    Decrease in Trait anxiety (State-Trait Anxiety Inventory, Spielberger, 1977) in the prebiotics group in comparison to the placebo group.. For this inventory, a lower overall score is the desired outcome.

  4. Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 2 [ Time Frame: 4 weeks of intervention ]
    Decrease in Social Anxiety for adolescents (Social Anxiety Scales, La Greca, 1999) in the prebiotics group in comparison to the placebo group. For this scale, a lower overall score is the desired outcome.

  5. Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 3 [ Time Frame: 4 weeks of intervention ]
    Increase in thought control ability (Thought control ability questionnaire, Luciano et al., 2005) in the prebiotics group in comparison to the placebo group.. For this questionnaire, a higher overall score is the desired outcome.

  6. Changes in gut microbiome composition as a function of prebiotic intake [ Time Frame: 4 weeks of intervention ]
    Increase in beneficial gut bacteria (percentage) in the prebiotics group in comparison to the placebo group. Based on stool sample analyses and microbiome sequencing.

  7. Changes in gut microbiome composition as a function of prebiotic intake [ Time Frame: 4 weeks of intervention ]
    Increase in diversity of gut bacteria in the prebiotics group (number of different bacteria) in comparison to the placebo group. Based on stool sample analyses and microbiome sequencing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835468


Contacts
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Contact: Kathrin Cohen Kadosh, PhD 01483 68 3968 k.cohenkadosh@surrey.ac.uk

Locations
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United Kingdom
University of Surrey Recruiting
Guildford, Surrey, United Kingdom, GU2 7XH
Contact: Kathrin Cohen-Kadosh, Phd    01483683968    k.cohenkadosh@surrey.ac.uk   
Contact: Nicola Johnstone, Phd       nicola.johnstone@surrey.ac.uk   
Sponsors and Collaborators
University of Surrey
FrieslandCampina
Investigators
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Principal Investigator: Kathrin Cohen Kadosh, PhD University of Surrey

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Responsible Party: Katherin Cohen-Kadosh, Associate Professor in Developmental Cognitive Neuroscience, University of Surrey
ClinicalTrials.gov Identifier: NCT03835468     History of Changes
Other Study ID Numbers: PrebioticExtensionStudyGU2
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No