Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Instituto de Cardiologia do Rio Grande do Sul

Status: Unknown

Conditions: Dysbiosis; Autonomic Nervous System Imbalance; Menopause; Systemic Arterial Hypertension

Treatments: Dietary Supplement: Probiotic supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT03955159

549019

Details and patient eligibility

About

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.

Full 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

Enrollment: 86 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups, including a placebo group

Experimental: Probiotic supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic supplementation

Placebo comparator

Placebo Comparator group

Description:

The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder.

Treatment:

Dietary Supplement: Probiotic supplementation