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

NCT ID: NCT05820321

Last Updated: 2023-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal; Menorrhagia Physical Inactivity Motor Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental (Beetroot juice NO3)

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

Group Type ACTIVE_COMPARATOR

Beetroot juice rich in nitrate

Intervention Type DIETARY_SUPPLEMENT

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 (Beetroot juice without NO3)

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

Group Type PLACEBO_COMPARATOR

Beetroot juice NO3 depleted

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cicero Jonas R Benjamim

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cicero Jonas Rodrigues Benjamim

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cicero JR Benjamim

Role: primary

07775453372

Cicero Jonas R. Benjamim, PhD Student

Role: primary

87988621194

References

Explore related publications, articles, or registry entries linked to this study.

Benjamim CJR, Lopes da Silva LS, da Silva Goncalves L, Tasinafo Junior MF, Spellanzon B, Rebelo MA, Tanus-Santos JE, Bueno Junior CR. The effects of dietary nitrate ingestion on physical performance tests in 50-65 years old postmenopausal women: A pilot randomized, double-blind, placebo-controlled, and crossover study. Clin Nutr. 2024 Jul;43(7):1642-1646. doi: 10.1016/j.clnu.2024.05.031. Epub 2024 May 22.

Reference Type DERIVED
PMID: 38805867 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BEET-MS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dietary Nitrate in COPD
NCT02148289 COMPLETED NA
Beet Root Supplement Trial
NCT02010502 COMPLETED NA