Systemic Arterial HypertensionNCT03955159
Effects of Probiotic Supplementation in Hypertensive Women on Menopause
A study testing Probiotic supplementation in people with Systemic Arterial Hypertension and Menopause, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Systemic Arterial Hypertension, Menopause, Dysbiosis
- What is being tested?
- Probiotic supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jun 2019to 10 Aug 2021
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive
- At least 1 year of menopause
- Sedentary
Who cannot join
- Smoker
- Use of psychiatric medications
- Cardiovascular events
- Recent surgeries
- Diabetic
- Use of beta blockers
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90040371
Liliana Fortini Cavalheiro Boll, Msc, 051 32303600 ext. 4070, liliana.lic@cardiologia.org.br
About this study
Official title: Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.
Read the detailed description
After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.
The study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.
The intervention groups will be as follows:
- - Menopausal women with hypertension + Probiotic supplementation
- - Menopausal women with hypertension + Placebo supplementation
- Being tested
- Probiotic supplementation
- Medical subject headings
- Hypertension, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementationDietary supplement
The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Probiotic supplementation | Experimental | The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration. Receives: Dietary Supplement: Probiotic supplementation |
| Placebo comparator | Placebo comparator | The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder. Receives: Dietary Supplement: Probiotic supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Nervous System
The data will be collected through the system of acquisition of pressure waves in a continuous and non-invasive way by the Finometer® system, through a cuffing installed in the middle finger, taking this signal to an analog-to-digital signal converter. The pulse pressure signal will be acquired at 1000 Hz, continuously and non-invasively, supine (10 minutes) in a quiet environment, with controlled temperature (± 23 ° C) and illumination.
The collected data will be saved in the software BeatsScope® and LabChart®, from which will be extracted the syistograms for analysis.
The autonomic nervous system will be assessed at baseline and after 3 months of intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start10 Jun 2019
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Arterial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline Dalmazo, Instituto de Cardiologia do Rio Grande do Sul
- Investigators
- Maria Claudia Irigoyen, PhD, Study chair, Instituto de Cardiologia - Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955159
- Sponsor's protocol ID
- 549019
- Status last verified
- Jan 2020
- First submitted
- 15 Apr 2019
- Last updated
- 27 Jan 2020
- Results posted
- 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 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT03955159
- Acronym / sponsor ID
- 549019
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Aug 2021 (estimated)
- First posted
- 17 May 2019 (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.
In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.
Detailed description
After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.
The study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.
The intervention groups will be as follows:
- - Menopausal women with hypertension + Probiotic supplementation
- - Menopausal women with hypertension + Placebo supplementation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Probiotic supplementation | Experimental | Dietary Supplement: Probiotic supplementationThe probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration. |
| Placebo comparator | Placebo comparator | Dietary Supplement: Probiotic supplementationThe placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertensive
- At least 1 year of menopause
- Sedentary
Key exclusion criteria (6 listed)
- Smoker
- Use of psychiatric medications
- Cardiovascular events
- Recent surgeries
- Diabetic
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 supplementationThe probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration. | Dietary supplement | Experimental: Probiotic supplementation, Placebo comparator |
Primary outcome
Autonomic Nervous System
Time frame: 3 months
The data will be collected through the system of acquisition of pressure waves in a continuous and non-invasive way by the Finometer® system, through a cuffing installed in the middle finger, taking this signal to an analog-to-digital signal converter. The pulse pressure signal will be acquired at 1000 Hz, continuously and non-invasively, supine (10 minutes) in a quiet environment, with controlled temperature (± 23 ° C) and illumination. The collected data will be saved in the software BeatsScope® and LabChart®, from which will be extracted the syistograms for analysis. The autonomic nervous system will be assessed at baseline and after 3 months of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- 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.
Maria Claudia Irigoyen, PhD study chair
Instituto de Cardiologia - Fundação Universitária de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplementation in people with Systemic Arterial Hypertension and Menopause, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 6 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 27 Jan 2020. 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 Brazil. 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 Aline Dalmazo, Especialist (+5551999774646, aline@dalmazo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Nervous System (time frame: 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 27 Jan 2020.