Back to results

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

Primary Purpose

Postmenopausal; Menorrhagia, Physical Inactivity, Motor Activity

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Beetroot juice rich in nitrate

Beetroot juice NO3 depleted

About this trial

This is an interventional treatment trial for Postmenopausal; Menorrhagia

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

Cicero Jonas Rodrigues BenjamimRecruiting
EEFERP - USP / Laboratório de Fisiologia do Exercício e MetabolismoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental (Beetroot juice NO3)

Placebo (Beetroot juice without NO3)

Arm Description

8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days.

8-day supplementation with beetroot juice NO3 depleted during 8 days.

Outcomes

Primary Outcome Measures

Handgrip strength test (kgf)

Secondary Outcome Measures

Six minute walk test (distance in meters)

Arm curl test (repetitions)

Sit-to-stand test (repetitions)

8-foot up and go test (seconds)

Full Information

NCT ID

NCT05820321

First Posted

January 27, 2023

Last Updated

June 10, 2023

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT05820321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

August 20, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal; Menorrhagia, Physical Inactivity, Motor Activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental (Beetroot juice NO3)

Arm Type

Active Comparator

Arm Description

8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days.

Arm Title

Placebo (Beetroot juice without NO3)

Arm Type

Placebo Comparator

Arm Description

8-day supplementation with beetroot juice NO3 depleted during 8 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Beetroot juice rich in nitrate

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Beetroot juice NO3 depleted

Intervention Description

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.

Primary Outcome Measure Information:

Title

Handgrip strength test (kgf)

Time Frame

up to 2 years

Secondary Outcome Measure Information:

Title

Six minute walk test (distance in meters)

Time Frame

up to 2 years

Title

Arm curl test (repetitions)

Time Frame

up to 2 years

Title

Sit-to-stand test (repetitions)

Time Frame

up to 2 years

Title

8-foot up and go test (seconds)

Time Frame

up to 2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Cicero Jonas Rodrigues Benjamim

City

Ribeirao Preto

State/Province

ZIP/Postal Code

05508-900

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cicero JR Benjamim

Phone

07775453372

jonasbenjamim@usp.br

Facility Name

EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo

City

Ribeirão Preto

State/Province

São Paulo

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cicero Jonas R. Benjamim, PhD Student

Phone

87988621194

benjamim.nutricao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs