Healthy LifestyleIBMANCT04823533
Improving Wellbeing Through the Brain-Gut-Microbiota Axis
A study of Healthy Lifestyle, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChile
- Study dates
- 30 Mar 2021to 11 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 7790702
About this study
Official title: A Psychophysiological Study of the Bidirectional Communication Mechanisms Between the Brain and the Gastrointestinal System and Its Effects on Well-being
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.
Read the detailed description
Within the field of Psychology and Contemplative Sciences, the relationship and interdependence between the brain and body have been one of the most prevalent questions when it comes to understanding the psychobiological mechanisms underlying human behavior. It is proposed that the brain should be seen as a dynamic, complex, and self-organized system, which is closely coupled and integrated with whole-body signals, establishing a two-way communication axis. This has been evidenced through an increase in scientific research adopting an embodied perspective that considers both diverse brain measurements as well as signals from other parts of the body, such as the heart and the gastrointestinal system. Recent pieces of evidence have furthermore begun to reveal the different ways in which psychological processes can influence the body, and how this could be trained in order to improve wellness.
Interoception is a cognitive process developed to monitor the internal state of the body and it involves the continuous and dynamic integration of information from different (internal) origins, including respiratory, cardiac, and gastrointestinal systems. New research agendas have started to link interoception to wellbeing, and with the psychopathology of psychiatric conditions, from depression and autism to eating disorders. Interestingly, it has been shown that this ability can be trained through contemplative practices designed to improve body awareness, socio-affective and socio-cognitive capacity. Moreover, some interoceptive dimensions like thirst interoception might be affected by lifestyle and habits such as diet. Altogether, this evidence suggests that understanding the mechanism of brain-body integration represents a promising alternative to improve wellbeing and mental health.
One example of psychophysical integration that has taken much importance in recent years, due to its implications on wellbeing and mental health, is the one established between the brain and the gastrointestinal system. In particular, gut-microbiota research is acquiring special importance because of its implications in psychological states such as stress and anxiety, and psychiatric conditions like depression and autism. It has been shown that microbiota affects brain functioning through different pathways including neural, humoral, and endocrine. However, the mechanism of brain-gut-microbiota integration and its relationship to wellbeing is still unknown. The integration of information through large-scale oscillation coupling has been one of the most validated proposals regarding signal processing and communication. An oscillatory coupling between the brain and the gastrointestinal system was recently described, shedding light on a possible mechanism via which the gastrointestinal system constantly and instantaneously sends information to the brain, which in turn integrates this information either consciously or unconsciously, thus affecting mental processes.
This research proposal aims to study how the brain integrates information from the gut (regulated by the microbiota) and the relevance of this coupling on wellbeing. To do this, the oscillatory coupling between the electroencephalogram (EEG) and electrogastrogram (EGG) signals will be recorded and evaluated. EEGs and EGGs will be recorded under different interventions including training designed to increase interoceptive gastric awareness and treatment with probiotics to modify some microorganisms that have already been associated with mental health. The oscillatory coupling will be compared to the well-being observed after each of the interventions. In this investigation, wellbeing will be defined as optimal psychological functioning, integrating physical and subjective factors, and will be evaluated through different self-reported questionnaires.
Interventions related to improving body awareness and contemplative practices, in general, are helping to improve the levels of wellness around the world and in Chile, representing an accessible and cheap way to manage psychological conditions regardless of socioeconomic and demographic aspects, contributing to the development of new therapeutic strategies. Additionally, a strong relationship between diet, microbiota, and health has now been demonstrated. Thus, understanding the mechanism via which the microbiota communicates with the brain, the susceptibility of this communication to microbiota changes, and the relationship of this process with participants' diet could provide relevant information when making decisions related to eating habits and lifestyles.
- Conditions
- Healthy Lifestyle
- Being tested
- Probiotic-placebo supplement
- Keywords
- Microbiota, Brain-gut, Wellbeing, Interoception, Probiotic, Electrophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic-placebo supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Probiotic-placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start30 Mar 2021
- Primary completion15 Jun 2021
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chile, Instituto de Nutrición y Tecnología de los Alimentos, University Diego Portales, Lallemand SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823533
- Sponsor's protocol ID
- 181014002
- Acronym
- IBMA
- Status last verified
- Jun 2022
- First submitted
- 5 Mar 2021
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Psychophysiological Study of the Bidirectional Communication Mechanisms Between the Brain and the Gastrointestinal System and Its Effects on Well-being
- ClinicalTrials.gov ID
- NCT04823533
- Acronym / sponsor ID
- IBMA / 181014002
- Conditions
- Healthy Lifestyle
- Keywords
- Microbiota, Brain-gut, Wellbeing, Interoception, Probiotic, Electrophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- University of Chile, Instituto de Nutrición y Tecnología de los Alimentos, University Diego Portales, Lallemand SAS
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Within the field of Psychology and Contemplative Sciences, the relationship and interdependence between the brain and body have been one of the most prevalent questions when it comes to understanding the psychobiological mechanisms underlying human behavior. It is proposed that the brain should be seen as a dynamic, complex, and self-organized system, which is closely coupled and integrated with whole-body signals, establishing a two-way communication axis. This has been evidenced through an increase in scientific research adopting an embodied perspective that considers both diverse brain measurements as well as signals from other parts of the body, such as the heart and the gastrointestinal system. Recent pieces of evidence have furthermore begun to reveal the different ways in which psychological processes can influence the body, and how this could be trained in order to improve wellness.
Interoception is a cognitive process developed to monitor the internal state of the body and it involves the continuous and dynamic integration of information from different (internal) origins, including respiratory, cardiac, and gastrointestinal systems. New research agendas have started to link interoception to wellbeing, and with the psychopathology of psychiatric conditions, from depression and autism to eating disorders. Interestingly, it has been shown that this ability can be trained through contemplative practices designed to improve body awareness, socio-affective and socio-cognitive capacity. Moreover, some interoceptive dimensions like thirst interoception might be affected by lifestyle and habits such as diet. Altogether, this evidence suggests that understanding the mechanism of brain-body integration represents a promising alternative to improve wellbeing and mental health.
One example of psychophysical integration that has taken much importance in recent years, due to its implications on wellbeing and mental health, is the one established between the brain and the gastrointestinal system. In particular, gut-microbiota research is acquiring special importance because of its implications in psychological states such as stress and anxiety, and psychiatric conditions like depression and autism. It has been shown that microbiota affects brain functioning through different pathways including neural, humoral, and endocrine. However, the mechanism of brain-gut-microbiota integration and its relationship to wellbeing is still unknown. The integration of information through large-scale oscillation coupling has been one of the most validated proposals regarding signal processing and communication. An oscillatory coupling between the brain and the gastrointestinal system was recently described, shedding light on a possible mechanism via which the gastrointestinal system constantly and instantaneously sends information to the brain, which in turn integrates this information either consciously or unconsciously, thus affecting mental processes.
This research proposal aims to study how the brain integrates information from the gut (regulated by the microbiota) and the relevance of this coupling on wellbeing. To do this, the oscillatory coupling between the electroencephalogram (EEG) and electrogastrogram (EGG) signals will be recorded and evaluated. EEGs and EGGs will be recorded under different interventions including training designed to increase interoceptive gastric awareness and treatment with probiotics to modify some microorganisms that have already been associated with mental health. The oscillatory coupling will be compared to the well-being observed after each of the interventions. In this investigation, wellbeing will be defined as optimal psychological functioning, integrating physical and subjective factors, and will be evaluated through different self-reported questionnaires.
Interventions related to improving body awareness and contemplative practices, in general, are helping to improve the levels of wellness around the world and in Chile, representing an accessible and cheap way to manage psychological conditions regardless of socioeconomic and demographic aspects, contributing to the development of new therapeutic strategies. Additionally, a strong relationship between diet, microbiota, and health has now been demonstrated. Thus, understanding the mechanism via which the microbiota communicates with the brain, the susceptibility of this communication to microbiota changes, and the relationship of this process with participants' diet could provide relevant information when making decisions related to eating habits and lifestyles.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic-placebo supplementA 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 | Placebo comparator | Dietary Supplement: Probiotic-placebo supplementPlacebo formulation containing only the excipients used were as follows: xylitol, maltodextrin, plum flavor, and malic acid. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic-placebo supplementA 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 | Placebo, Probiotic |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS) at baseline
Time frame: Week 0
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).
Difficulties in Emotion Regulation Scale (DERS) after intervention
Time frame: Week 4
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)
Difficulties in Emotion Regulation Scale (DERS) - follow up
Time frame: Week 12
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)
Ryff Scales of Psychological Well-Being (PWB) at baseline
Time frame: Week 0
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)
Ryff Scales of Psychological Well-Being (PWB) post intervention
Time frame: Week 4
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)
Ryff Scales of Psychological Well-Being (PWB) - follow-up
Time frame: Week 12
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)
Satisfaction With Life Scale (SWLS) at baseline
Time frame: Week 0
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).
Satisfaction With Life Scale (SWLS) post intervention
Time frame: Week 4
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)
Satisfaction With Life Scale (SWLS) - follow-up
Time frame: Week 12
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)
The State-Trait Anxiety Inventory (STAI) - State at baseline
Time frame: Week 0
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).
The State-Trait Anxiety Inventory (STAI) - State post intervention
Time frame: Week 4
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)
The State-Trait Anxiety Inventory (STAI) - State - follow-up
Time frame: Week 12
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)
Positive and Negative Affect Schedule (PANAS) at baseline
Time frame: Week 0
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).
Positive and Negative Affect Schedule (PANAS) post intervention
Time frame: Week 4
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).
Positive and Negative Affect Schedule (PANAS) - follow-up
Time frame: Week 12
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)
The Five Facet Mindfulness Questionnaire (FFMQ) at baseline
Time frame: Week 0
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).
The Five Facet Mindfulness Questionnaire (FFMQ) post intervention
Time frame: Week 4
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).
The Five Facet Mindfulness Questionnaire (FFMQ) - follow-up
Time frame: Week 12
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)
Gut microbiota
Time frame: Week 0
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.
Water load test (Gastric Interoception) at baseline
Time frame: Week 0
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
Water load test (Gastric Interoception) post intervention
Time frame: Week 4
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
Water load test (Gastric Interoception) - follow-up
Time frame: Week 12
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)
Multidimensional questionnaire of interoceptive awareness (MAIA) at baseline
Time frame: Week 0
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)
Multidimensional questionnaire of interoceptive awareness (MAIA) post intervention
Time frame: Week 4
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)
Multidimensional questionnaire of interoceptive awareness (MAIA) follow-up
Time frame: Week 12
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)
Brain-gut coupling using the modulation index
Time frame: Week 0
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy Lifestyle, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difficulties in Emotion Regulation Scale (DERS) at baseline (time frame: Week 0). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.