BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN

NCT06584331 | Active Not Recruiting DMC

• 3 other identifiers: 01.78649524.4.0000.5152APQ-01874-18175522/2023-5
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to verify the hemodynamic and biomarker responses of beetroot juice intake in postmenopausal women with hypertension. The main questions it aims to answer are: Is beetroot juice dose related to better hemodynamic responses in hypertensive postmenopausal women? Is beetroot juice dose related to better oxidative stress profile responses in hypertensive postmenopausal women? The investigators will conduct a parallel clinical study with 10 days of intervention, in which 48 women will be randomized into 3 groups: 1) Two shots of beetroot juice intake per day (800mg of NO3-); 2) One shot of beetroot juice intake per day (400mg of NO3-); 3) placebo intake (beetroot juice without NO3-).

Conditions

Hypertension; Menopause

Keywords

beetroot juice; hypertension; postmenopausal; blood pressure

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Volunteers will undergo blood pressure tests at the beginning, in the middle and after the 10 days of intervention. To assess blood pressure (BP), researchers will use the Dyna Mapa + Cardius® device, programmed with measurements to be taken every 20 min. Together with this device, the volunteers filled out a daily record of activities such as sleep, work, food, or any event that could interfere with BP or measurements. In a standardized manner, the device was set at 7 a.m., and measurements were considered valid when 24h of monitoring were obtained. Resting BP was measured with the same device after 15 min of rest in a sitting position, and for the analysis of the pressure curve, time 0 was adopted when the monitor was placed. Sytolic BP, diastolic BP, and mean BP in periods of awake, sleep and 24 h were analyzed.

  11 days

Secondary Outcomes (8)

• Stroop color and word test

  11 days

• Heart rate variability

  11 days

• Superoxide Dismutase

  11 days

• Catalase

  11 days

• Glutathione Peroxidase

  11 days

Study Arms (3)

1 dose of beetroot juice

EXPERIMENTAL

The volunteers will ingest 70 ml of beetroot juice with 400 mg of nitrate every morning for 10 days

Dietary Supplement: 1 dose of Beetroot juice intake

2 doses of beetroot juice

EXPERIMENTAL

This group will ingest 2 shots of 70 ml of beetroot juice with 400mg of nitrate, in each shot, for 10 days.

Dietary Supplement: 2 doses of Beetroot juice intake

Placebo

PLACEBO COMPARATOR

In this group, the participants will receive a low-nitrate beetroot juice dose to consume in the morning.

Dietary Supplement: Placebo

Interventions

1 dose of Beetroot juice intake DIETARY_SUPPLEMENT

The volunteers will ingest 70 ml of beetroot juice with 400 mg of nitrate every morning for 10 days

1 dose of beetroot juice

2 doses of Beetroot juice intake DIETARY_SUPPLEMENT

This group will ingest 2 shots of 70 ml of beetroot juice with 400mg of nitrate, in each shot, for 10 days.

2 doses of beetroot juice

Placebo DIETARY_SUPPLEMENT

In this group, the participants will receive 70ml of low-nitrate beetroot juice to consume in the morning.

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amenorrhea for at least 12 months
• Controlled hypertension

You may not qualify if:

• Decompensated hypertension in stages 2 and 3
• Having a history of stroke or acute myocardial infarction
• Smoker
• Having a diagnosis of Diabetes Mellitus
• Using hormone therapy.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

FAEFI

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 4, 2024
• Study Start: August 7, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)