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

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05820321

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

7.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal; Menorrhagia Physical Inactivity Motor Activity	Dietary Supplement: Beetroot juice rich in nitrate Other: Beetroot juice NO3 depleted	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Apr 20, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Handgrip strength test (kgf) [up to 2 years]

Secondary Outcome Measures

Six minute walk test (distance in meters) [up to 2 years]
Arm curl test (repetitions) [up to 2 years]
Sit-to-stand test (repetitions) [up to 2 years]
8-foot up and go test (seconds) [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cicero Jonas Rodrigues Benjamim	Ribeirao Preto	SP	Brazil	05508-900
2	EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo	Ribeirão Preto	São Paulo	Brazil

Sponsors and Collaborators

University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cicero Jonas R Benjamim, Principal investigator, University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT05820321

Other Study ID Numbers:

BEET-MS

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Menorrhagia

Study Results

No Results Posted as of Apr 26, 2023