NCT05820321

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

January 27, 2023

Last Update Submit

June 10, 2023

Conditions

Postmenopausal; MenorrhagiaPhysical InactivityMotor Activity

Outcome Measures

Primary Outcomes (1)

  • Handgrip strength test (kgf)

    up to 2 years

Secondary Outcomes (4)

  • 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

Study Arms (2)

Experimental (Beetroot juice NO3)

ACTIVE COMPARATOR

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

Dietary Supplement: Beetroot juice rich in nitrate

Placebo (Beetroot juice without NO3)

PLACEBO COMPARATOR

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

Other: Beetroot juice NO3 depleted

Interventions

Beetroot juice rich in nitrateDIETARY_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.

Experimental (Beetroot juice NO3)
Beetroot juice NO3 depletedOTHER

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.

Placebo (Beetroot juice without NO3)

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cicero Jonas Rodrigues Benjamim

Ribeirão Preto, São Paulo, 05508-900, Brazil

RECRUITING

EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo

Ribeirão Preto, São Paulo, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38805867DERIVED

MeSH Terms

Conditions

MenorrhagiaSedentary BehaviorMotor Activity

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesBehavior

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 27, 2023

First Posted

April 19, 2023

Study Start

July 1, 2022

Primary Completion

August 20, 2023

Study Completion

December 31, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

BR(2)