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RecruitingNCT05820321Updated Jun 13, 2023

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

An interventional study of Beetroot juice rich in nitrate and Beetroot juice NO3 depleted in Postmenopausal; Menorrhagia, Physical Inactivity and Motor Activity, sponsored by University of Sao Paulo. Recruiting at 2 sites in Brazil. Open to female participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-06-13.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Jul 2022, registered Jan 2023).
  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postmenopausal; Menorrhagia
  • Physical Inactivity
  • Motor Activity

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03

In context

Menorrhagia

182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Smoking
  • Cardiac failure
  • Previous history of acute myocardial infarction and/or stroke;
  • Allergy or intolerance to nitrate, gluten, or milk;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Placebo (Beetroot juice without NO3)

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

    Other: Beetroot juice NO3 depleted

Interventions

  • Dietary supplementBeetroot 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.

  • OtherBeetroot 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.

06

What researchers measure

Primary outcomes

  1. Handgrip strength test (kgf)

    Time frame: up to 2 years

Secondary outcomes

  1. Six minute walk test (distance in meters)

    Time frame: up to 2 years

  2. Arm curl test (repetitions)

    Time frame: up to 2 years

  3. Sit-to-stand test (repetitions)

    Time frame: up to 2 years

  4. 8-foot up and go test (seconds)

    Time frame: up to 2 years

07

Study locations

2 of 2 sites recruiting
  • Cicero Jonas Rodrigues Benjamim
    Ribeirao Preto, SP 05508-900, Brazil
    Recruiting
  • EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
    Ribeirão Preto, São Paulo, Brazil
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05820321
Lead sponsor
University of Sao Paulo
Responsible party
Cicero Jonas R Benjamim (Principal investigator, University of Sao Paulo) — Principal investigator
First posted
Apr 19, 2023
Start date
Jul 1, 2022
Primary completion
Aug 20, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jun 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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