HypertensionNCT05967715
Exercise Training Influences Gut Microbiota and Cardiovascular Health Through Inflammation Control in Adult Hypertensive Population: the MicroFit Study
A study testing exercise training and Probiotics in people with Hypertension and Microbiota, run by University of Bologna at 1 site in Italy.
Trial summary
Cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year (31% of deaths worldwide). Hypertension, with 1.13 billion people affected worldwide, is the leading risk factor for global mortality. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension, Microbiota
- What is being tested?
- exercise training and Probiotics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2023to 2 Apr 2026
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arterial hypertension*;
- Stable antihypertensive therapy in the last 2 months, with controlled blood pressure values;
- Age 40-65 years;
- Willing to sign the written informed consent;
- Written and spoken Italian language comprehension.
Who cannot join
- Atrial fibrillation;
- Diabetes mellitus either type I or II;
- Active cancer;
- Inflammatory bowel disease;
- Heart failure NYHA class III to IV;
- Recent antibiotic or probiotic treatment in the previous month for any reason;
Show all 12Show fewer
- Recent myocardial infarction or hospital admission for any other reason in the previous 6 months;
- Any other condition that the medical doctor (MD) considers to contraindicate the participation in an exercise program of High intensity;
- Pulmonary disease requiring oxygen therapy;
- Relevant neurological condition impairing motor or cognitive function;
- Severe depressive disorder;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Bologna
Bologna, 40138
Davide Agnoletti, PhD, 00390512145579, davide.agnoletti2@unibo.it
About this study
Cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year (31% of deaths worldwide). Hypertension, with 1.13 billion people affected worldwide, is the leading risk factor for global mortality. Physical inactivity is among the modifiable cardiovascular risk factors. While the beneficial effects of physical activity on cardiovascular system are widely known, the mechanisms involved are not completely understood. Both exercise training and hypertension are linked to inflammation. Furthermore, there is evidence that gut microbiota regulates inflammatory patterns. Recent investigations showed a relationship between exercise training and the composition/functionality of the gut microbiota. Anyway, the modification of the composition and functionality of the gut microbiota in hypertension due to the exercise training and the relative involvement of oxidative stress and inflammation are not completely understood.
In literature an association between gut microbiota composition and arterial stiffness is described, in particular, the investigators observed both a direct correlation between arterial stiffness and abundances of bacteria associated with altered gut permeability and inflammation; and an inverse relationship between arterial stiffness, microbiota diversity, and abundances of bacteria associated with most fit microbiota composition. Anyway, while these association were stable in animal studies, in human studies none of the identified interventional trials was able to demonstrate this relationship. Of note, only half of human studies measured BP, and very few adjusted the vascular analyses for BP variation, which is a major determinant of arterial stiffness.
Read more
This is a non-profit, monocentric, non-pharmacological interventional study, a randomized controlled trial with three intervention arms, partial double-blind, aiming to verify the hypothesis that, in hypertensive patients in primary prevention with cardiovascular risk factors, physical exercise favorably modifies the intestinal bacterial flora compared to the probiotic, with a positive impact on cardiovascular health, and to demonstrate that this involves inflammation modulation. There will be 3 intervention arms, with 1:1:1 stratified randomization by gender: 1. Administration of controlled physical activity training; 2. Administration of probiotic; 3. Administration of placebo. Arms 2 and 3 will be double-blind. The intervention will last for three months, followed by a 6-month follow-up period. Afterwards, the medical team may be contacted for further tests/assessments or simply for information about the participant's health status, for a total duration of 24 months.
The investigators hypothesize that hypertensive patients in cardiovascular primary prevention have a dysbiotic gut microbial signatures, that could be a new marker of early vascular aging. Secondly, the investigators anticipate that exercise training will modify both gut microbiota and hemodynamic profile, and that a relationship exists between gut microbiota and hemodynamic modifications. Thirdly, the investigators expect that the beneficial effects of exercise training are driven by positive changes in the inflammatory modulators.
- Conditions
- Hypertension, Microbiota
- Being tested
- exercise training, Probiotics, Placebo
- Keywords
- hypertension, gut microbiota, exercise training, physical activity, central hemodynamics, arterial stiffness, pulse wave velocity
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
high intensity interval training
ProbioticsOther
VSL#3# Probiotic
PlaceboOther
Probiotic Placebo
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | high intensity interval training: thrice a week Receives: Behavioral: exercise training |
| Probiotics | Active comparator | VSL#3# probiotic: twice daily Receives: Other: Probiotics |
| Placebo | Placebo comparator | Comparator of the Probiotics arm Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the modification of the gut microbiota composition and function after the exercise training compared to probiotic supplements and to placebo.
Changes in measures of gut microbiota composition and function from time 0 to 3 months (alpha diversity, beta diversity, taxonomy, relative abundance of microbial genes and pathways)
Measured: time 0 and 3 months
Secondary outcomes (7)
To describe the association between gut microbiota patterns with impaired central hemodynamics
To measure the association of gut microbiota diversity indexes, taxonomy, relative abundance of microbial genes and pathways, with central hemodynamics parameters (central blood pressure, aortic stiffness, pulse pressure amplification, augmentation index).
Measured: time 0 and 3 months
To test the association of the systemic inflammation with the modification of gut microbiota composition/functionality.
To test the association between inflammatory markers (alpha-1-acid glycoprotein, high-sensitive c-reactive protein) and gut microbiota diversity indexes, taxonomy, relative abundance of microbial genes and pathways.
Measured: time 0 and 3 months
To test the modification of endothelial function after the exercise training in comparison to probiotic supplements and placebo.
To measure variation in endothelial glycocalyx thickness before and after 3-mo intervention
Measured: time 0, and 3 months
To identify the variation of the gut microbiota composition and function in the long term follow up after the intervention
Measures of gut microbiota diversity indexes, taxonomy, relative abundance of microbial genes and pathways at the end of the intervention (3 months) and after the 9-mo follow up.
Measured: from 3 to 9 months.
To describe the association between gut microbiota patterns with impaired central hemodynamics in the long term follow up 6 months after the intervention
To measure the association of gut microbiota diversity indexes, taxonomy, relative abundance of microbial genes and pathways, with central hemodynamics parameters (central blood pressure, aortic stiffness, pulse pressure amplification, augmentation index)
Measured: at 9-mo follow up
To test the association of the systemic inflammation with the modification of gut microbiota composition/functionality, after the long term follow up 6 months after the intervention.
To test the association between inflammatory markers (alpha-1-acid glycoprotein, high-sensitive c-reactive protein) and gut microbiota diversity indexes, taxonomy, relative abundance of microbial genes and pathways, at 9-mo follow up.
Measured: at 9-mo follow up
To test the modification of endothelial function after the exercise training in comparison to probiotic supplements and placebo, after the long term follow up 6 months after the intervention
To measure variation in endothelial glycocalyx thickness at 9-mo follow up
Measured: at 9-mo follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start3 Apr 2023
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- Actial Farmaceutica S.r.l.
- Responsible party
- Principal investigator, Davide Agnoletti, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967715
- Sponsor's protocol ID
- MicroFit
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Influences Gut Microbiota and Cardiovascular Health Through Inflammation Control in Adult Hypertensive Population: the MicroFit Study
- ClinicalTrials.gov ID
- NCT05967715
- Acronym / sponsor ID
- MicroFit
- Conditions
- Hypertension, Microbiota
- Keywords
- hypertension, gut microbiota, exercise training, physical activity, central hemodynamics, arterial stiffness, pulse wave velocity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- Actial Farmaceutica S.r.l.
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
Cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year (31% of deaths worldwide). Hypertension, with 1.13 billion people affected worldwide, is the leading risk factor for global mortality. Physical inactivity is among the modifiable cardiovascular risk factors. While the beneficial effects of physical activity on cardiovascular system are widely known, the mechanisms involved are not completely understood. Both exercise training and hypertension are linked to inflammation. Furthermore, there is evidence that gut microbiota regulates inflammatory patterns. Recent investigations showed a relationship between exercise training and the composition/functionality of the gut microbiota. Anyway, the modification of the composition and functionality of the gut microbiota in hypertension due to the exercise training and the relative involvement of oxidative stress and inflammation are not completely understood.
In literature an association between gut microbiota composition and arterial stiffness is described, in particular, the investigators observed both a direct correlation between arterial stiffness and abundances of bacteria associated with altered gut permeability and inflammation; and an inverse relationship between arterial stiffness, microbiota diversity, and abundances of bacteria associated with most fit microbiota composition. Anyway, while these association were stable in animal studies, in human studies none of the identified interventional trials was able to demonstrate this relationship. Of note, only half of human studies measured BP, and very few adjusted the vascular analyses for BP variation, which is a major determinant of arterial stiffness.
This is a non-profit, monocentric, non-pharmacological interventional study, a randomized controlled trial with three intervention arms, partial double-blind, aiming to verify the hypothesis that, in hypertensive patients in primary prevention with cardiovascular risk factors, physical exercise favorably modifies the intestinal bacterial flora compared to the probiotic, with a positive impact on cardiovascular health, and to demonstrate that this involves inflammation modulation. There will be 3 intervention arms, with 1:1:1 stratified randomization by gender: 1. Administration of controlled physical activity training; 2. Administration of probiotic; 3. Administration of placebo. Arms 2 and 3 will be double-blind. The intervention will last for three months, followed by a 6-month follow-up period. Afterwards, the medical team may be contacted for further tests/assessments or simply for information about the participant's health status, for a total duration of 24 months.
The investigators hypothesize that hypertensive patients in cardiovascular primary prevention have a dysbiotic gut microbial signatures, that could be a new marker of early vascular aging. Secondly, the investigators anticipate that exercise training will modify both gut microbiota and hemodynamic profile, and that a relationship exists between gut microbiota and hemodynamic modifications. Thirdly, the investigators expect that the beneficial effects of exercise training are driven by positive changes in the inflammatory modulators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: exercise traininghigh intensity interval training: thrice a week |
| Probiotics | Active comparator | Other: ProbioticsVSL#3# probiotic: twice daily |
| Placebo | Placebo comparator | Other: PlaceboComparator of the Probiotics arm |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Arterial hypertension*;
- Stable antihypertensive therapy in the last 2 months, with controlled blood pressure values;
- Age 40-65 years;
- Willing to sign the written informed consent;
- Written and spoken Italian language comprehension.
Key exclusion criteria (12 listed)
- Atrial fibrillation;
- Diabetes mellitus either type I or II;
- Active cancer;
- Inflammatory bowel disease;
- Heart failure NYHA class III to IV;
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 |
|---|---|---|
| exercise traininghigh intensity interval training | Behavioural | Exercise training |
| ProbioticsVSL#3# Probiotic | Other | Probiotics |
| PlaceboProbiotic Placebo | Other | Placebo |
Primary outcome
To describe the modification of the gut microbiota composition and function after the exercise training compared to probiotic supplements and to placebo.
Time frame: time 0 and 3 months
Changes in measures of gut microbiota composition and function from time 0 to 3 months (alpha diversity, beta diversity, taxonomy, relative abundance of microbial genes and pathways)
7 secondary outcomes
To describe the association between gut microbiota patterns with impaired central hemodynamics
Time frame: time 0 and 3 months
To test the association of the systemic inflammation with the modification of gut microbiota composition/functionality.
Time frame: time 0 and 3 months
To test the modification of endothelial function after the exercise training in comparison to probiotic supplements and placebo.
Time frame: time 0, and 3 months
To identify the variation of the gut microbiota composition and function in the long term follow up after the intervention
Time frame: from 3 to 9 months.
To describe the association between gut microbiota patterns with impaired central hemodynamics in the long term follow up 6 months after the intervention
Time frame: at 9-mo follow up
To test the association of the systemic inflammation with the modification of gut microbiota composition/functionality, after the long term follow up 6 months after the intervention.
Time frame: at 9-mo follow up
To test the modification of endothelial function after the exercise training in comparison to probiotic supplements and placebo, after the long term follow up 6 months after the intervention
Time frame: at 9-mo follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training and Probiotics in people with Hypertension and Microbiota, run by University of Bologna at 1 site in Italy.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davide Agnoletti, PhD (00390512145597, davide.agnoletti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the modification of the gut microbiota composition and function after the exercise training compared to probiotic supplements and to placebo. (time frame: time 0 and 3 months). 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 1 Aug 2023.