Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women

June 10, 2023 updated by: Cicero Jonas R Benjamim, University of Sao Paulo

Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women: a Randomized Trial

Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 15 physically inactive hypertensive women will participate a 8-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 8-day washout interval.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Ribeirao Preto, SP, Brazil, 05508-900
        • Recruiting
        • Cicero Jonas Rodrigues Benjamim
        • Contact:
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil
        • Recruiting
        • EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 50 to 65 years old
  • Physically inactive
  • Postmenopausal diagnosis (amenorrhea for 12 months or more);

Exclusion Criteria:

  • Smoking
  • Cardiac failure
  • Previous history of acute myocardial infarction and/or stroke;
  • Allergy or intolerance to nitrate, gluten, or milk;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental (Beetroot juice NO3)
8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days.
Dietary supplement: Beetroot juice rich in nitrate
The participant will intake beetroot juice rich in NO3 (400mg) during 8-days. On the eighth day of the intervention, 2 hours after intake the last bottle of juice, the participants will return to the laboratory for the performance tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.
Placebo Comparator: Placebo (Beetroot juice without NO3)
8-day supplementation with beetroot juice NO3 depleted during 8 days.
Other: Beetroot juice NO3 depleted
The participant will intake beetroot juice depleted in NO3. On the eighth day of the intervention, 2 hours after intake the last bottle of juice, the participants will to the laboratory for the performance tests evaluation. Before crossover protocol a 7-day washout interval will be given for the purification of the compounds provided by the protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Handgrip strength test (kgf)
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Six minute walk test (distance in meters)
Time Frame: up to 2 years
up to 2 years
Arm curl test (repetitions)
Time Frame: up to 2 years
up to 2 years
Sit-to-stand test (repetitions)
Time Frame: up to 2 years
up to 2 years
8-foot up and go test (seconds)
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

August 20, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEET-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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