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

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05820321
• Other study ID #: BEET-MS
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Menorrhagia
• Motor Activity
• Physical Inactivity

Intervention

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.

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.

Locations

Country	Name	City	State
Brazil	Cicero Jonas Rodrigues Benjamim	Ribeirao Preto	SP
Brazil	EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handgrip strength test (kgf)		up to 2 years
Secondary	Six minute walk test (distance in meters)		up to 2 years
Secondary	Arm curl test (repetitions)		up to 2 years
Secondary	Sit-to-stand test (repetitions)		up to 2 years
Secondary	8-foot up and go test (seconds)		up to 2 years