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Effects of Probiotic Supplementation in Hypertensive Women on Menopause

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ClinicalTrials.gov Identifier: NCT03955159
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aline Dalmazo, Instituto de Cardiologia do Rio Grande do Sul

Brief 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 cardiovascular risk.

Condition or disease Intervention/treatment Phase
Systemic Arterial Hypertension Menopause Dysbiosis Autonomic Nervous System Imbalance Dietary Supplement: Probiotic supplementation Not Applicable

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:

  1. - Menopausal women with hypertension + Probiotic supplementation
  2. - Menopausal women with hypertension + Placebo supplementation

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : March 10, 2021
Estimated Study Completion Date : August 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Experimental: Probiotic supplementation
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.
Dietary Supplement: Probiotic supplementation
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.

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.
Dietary Supplement: Probiotic supplementation
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.




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertensive
  • At least 1 year of menopause
  • Sedentary

Exclusion Criteria:

  • Smoker
  • Use of psychiatric medications
  • Cardiovascular events
  • Recent surgeries
  • Diabetic
  • Use of beta blockers

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955159


Contacts
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Contact: Aline Dalmazo, Especialist +5551999774646 aline@dalmazo.com
Contact: Maria Claudia Irigoyen, PhD +555132303600 hipirigoyen@gmail.com

Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
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Study Chair: Maria Claudia Irigoyen, PhD Instituto de Cardiologia - Fundação Universitária de Cardiologia

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Responsible Party: Aline Dalmazo, Principal Investigator, Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT03955159     History of Changes
Other Study ID Numbers: 549019
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Hypertension
Dysbiosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes