Improving Wellbeing Through the Brain-Gut-Microbiota Axis

NCT04823533 | Completed

• 1 other identifier: 181014002
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Well-being is a state defined as the optimal psychological functioning and the experience associated with it, integrating physical and subjective factors. It has been suggested that the bidirectional interaction between the brain and the rest of the body is fundamental in the regulation of wellbeing levels. In particular, the gastrointestinal system (modulated by the microbiota) sends information that is integrated by the brain, affecting its functioning and mental processes. However, the mechanism of such communication is still unknown. The aim of this proposal is to study the different ways in which psychological processes can influence gut signals and vice versa, and how this relationship might be trained or modified in order to improve wellbeing.

Conditions

Healthy Lifestyle

Keywords

Microbiota; Brain-gut; Wellbeing; Interoception; Probiotic; Electrophysiology

Outcome Measures

Primary Outcomes (26)

• Difficulties in Emotion Regulation Scale (DERS) at baseline

  The subjective experience associated with emotional regulation will be measured. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure).

  Week 0

• Difficulties in Emotion Regulation Scale (DERS) after intervention

  The subjective experience associated with emotional regulation will be measured. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post)

  Week 4

• Difficulties in Emotion Regulation Scale (DERS) - follow up

  The subjective experience associated with emotional regulation will be measured. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• Ryff Scales of Psychological Well-Being (PWB) at baseline

  The scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure)

  Week 0

• Ryff Scales of Psychological Well-Being (PWB) post intervention

  The scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post)

  Week 4

• Ryff Scales of Psychological Well-Being (PWB) - follow-up

  The scale measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• Satisfaction With Life Scale (SWLS) at baseline

  The Satisfaction With Life Scale (SWLS) was developed to assess satisfaction with the respondent's life as a whole. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure).

  Week 0

• Satisfaction With Life Scale (SWLS) post intervention

  The Satisfaction With Life Scale (SWLS) was developed to assess satisfaction with the respondent's life as a whole. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post)

  Week 4

• Satisfaction With Life Scale (SWLS) - follow-up

  The Satisfaction With Life Scale (SWLS) was developed to assess satisfaction with the respondent's life as a whole. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• The State-Trait Anxiety Inventory (STAI) - State at baseline

  The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. For this experiment, the anxiety assessment will be restricted exclusively to the state. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure).

  Week 0

• The State-Trait Anxiety Inventory (STAI) - State post intervention

  The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. For this experiment, the anxiety assessment will be restricted exclusively to the state. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post)

  Week 4

• The State-Trait Anxiety Inventory (STAI) - State - follow-up

  The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. For this experiment, the anxiety assessment will be restricted exclusively to the state. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• Positive and Negative Affect Schedule (PANAS) at baseline

  The Positive and Negative Affect Schedule (PANAS) comprises two mood scales, one that measures positive affect and the other which measures negative affect. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure).

  Week 0

• Positive and Negative Affect Schedule (PANAS) post intervention

  The Positive and Negative Affect Schedule (PANAS) comprises two mood scales, one that measures positive affect and the other which measures negative affect. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post).

  Week 4

• Positive and Negative Affect Schedule (PANAS) - follow-up

  The Positive and Negative Affect Schedule (PANAS) comprises two mood scales, one that measures positive affect and the other which measures negative affect. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• The Five Facet Mindfulness Questionnaire (FFMQ) at baseline

  The Five Facet Mindfulness Questionnaire is an established and valid psychometric self-assessment for mindfulness. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure).

  Week 0

• The Five Facet Mindfulness Questionnaire (FFMQ) post intervention

  The Five Facet Mindfulness Questionnaire is an established and valid psychometric self-assessment for mindfulness. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post).

  Week 4

• The Five Facet Mindfulness Questionnaire (FFMQ) - follow-up

  The Five Facet Mindfulness Questionnaire is an established and valid psychometric self-assessment for mindfulness. The five facets are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• Gut microbiota

  Plastic containers with the stool sample will be stored at -20 ° C in a refrigerator for the maintenance of biological samples located in the EPUC. Genomic DNA will be extracted from each sample and amplified in two steps. In the first step, a particular region encoding for a part of the 16s ribosomal RNA typical of prokaryotic organisms will be amplified by PCR. In a second step, a second PCR will be carried out in order to add the primers required for future sequencing. Finally, the results of the amplification will be quantified using qPCR, and will be stored in genomic libraries for subsequent sequencing and bioinformatic analysis \[50\]. This procedure will be performed to obtain the total bacterial colonies present in the faecal samples.

  Week 0

• Water load test (Gastric Interoception) at baseline

  Briefly, participants will have to drink room-temperature water for a period of 5 minutes until they feel signs of satiation at the beginning and then until feeling completely full of water. Different interoceptive indicators can be obtained using the water volumes required for feeling satiated and full. Participants will be evaluated by performing the task at baseline

  Week 0

• Water load test (Gastric Interoception) post intervention

  Briefly, participants will have to drink room-temperature water for a period of 5 minutes until they feel signs of satiation at the beginning and then until feeling completely full of water. Different interoceptive indicators can be obtained using the water volumes required for feeling satiated and full. Participants will be evaluated by performing the task after 4 weeks of intervention

  Week 4

• Water load test (Gastric Interoception) - follow-up

  Briefly, participants will have to drink room-temperature water for a period of 5 minutes until they feel signs of satiation at the beginning and then until feeling completely full of water. Different interoceptive indicators can be obtained using the water volumes required for feeling satiated and full. Participants will be evaluated by performing the task after 12 weeks since the baseline measure (follow-up)

  Week 12

• Multidimensional questionnaire of interoceptive awareness (MAIA) at baseline

  The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception by self-report. These are labeled Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trust For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire at the beginning of the experiment (baseline measure)

  Week 0

• Multidimensional questionnaire of interoceptive awareness (MAIA) post intervention

  The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception by self-report. These are labeled Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trust For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 4 weeks of the intervention (Post)

  Week 4

• Multidimensional questionnaire of interoceptive awareness (MAIA) follow-up

  The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 32 items to measure multiple dimensions of interoception by self-report. These are labeled Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trust For this, aspects of the subjective experience of the participants will be evaluated at the present time or in the daily life of their lives by completing the questionnaire after 12 weeks since the baseline measure (follow-up)

  Week 12

• Brain-gut coupling using the modulation index

  The brain-gut oscillatory coupling is one outcome that is obtained by measuring the power amplitude of the Electroencephalographic (EEG) and phase of the electrogastrographic (EGG) activity. The Brain-gut oscillatory coupling is obtained by calculating a modulation index between the phase of the EGG slow frequency gastric oscillations (0.05 Hz) and the power amplitude of EEG alpha oscillations (8-12 Hz). The modulation index is a measurement that indicates in which extend the phase of slow gastric oscillations modulate the amplitude of alpha waves For the EEG activity, 64 active electrodes will be positioned on a cap located on the participant's head. For the EGG record, a set of 16 skin electrodes will be positioned on the abdomen as described in Richter, Babo-Rebelo.

  Week 0

Study Arms (2)

Probiotic

EXPERIMENTAL

A probiotic formulation containing two well-documented probiotic strains. The finished product is a lyophilized powder packaged in single-dose sticks sachets Excipients used were as follows: xylitol, maltodextrin, plum flavor, and malic acid.

Dietary Supplement: Probiotic-placebo supplement

Placebo

PLACEBO COMPARATOR

Placebo formulation containing only the excipients used were as follows: xylitol, maltodextrin, plum flavor, and malic acid.

Dietary Supplement: Probiotic-placebo supplement

Interventions

Probiotic-placebo supplement DIETARY_SUPPLEMENT

A probiotic formulation containing two well-documented probiotic strains. The finished product is a lyophilized powder packaged in single-dose sticks sachets Excipients used were as follows: xylitol, maltodextrin, plum flavor, and malic acid.

Placebo; Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults of ≥ 18 to \& 65 years old of age.
• Able to provide written consent.
• Willing to provide stool samples and complete questionnaires, records, and diaries associated with the study
• Willingness to discontinue consumption of probiotic supplements for the duration of the study.

You may not qualify if:

• Concurrent consumption of probiotics. Subjects will be eligible for participation, however, after a four (4) week wash-out period.
• Known to be pregnant or breastfeeding or planning on becoming pregnant in the next two (2) months.
• Positive pregnancy test in women of childbearing potential.
• Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. The screened participant would be eligible to participate four (4) weeks after completing their course of antibiotics (wash-out period).
• Subject with diabetes or metabolic diseases.
• Subject with depression or psychiatric and neurological diseases.
• Subject with IBS or gastrointestinal diseases.
• Subject with immune disorders or with possible immune-deficient status (e.g. due to surgery).
• Milk or soy allergy.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• University of Chile: collaborator
• Instituto de Nutrición y Tecnología de los Alimentos: collaborator
• University Diego Portales: collaborator
• Lallemand SAS: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 7790702, Chile

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 30, 2021
• Study Start: March 30, 2021
• Primary Completion: June 15, 2021
• Study Completion: March 11, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

CL (1)