NCT05337527

Brief Summary

Beetroot juice supplementation has shown the capacity for provoking different physiological effects (e.g. vasodilation and muscle contraction increments). However, the effects of beetroot juice ingestion on neuromuscular performance in women older adults are barely studied. In this randomized placebo-controlled study, we investigated the effects of beetroot acute supplementation in improving neuromuscular performance in women older adults

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

17 days

First QC Date

April 13, 2022

Last Update Submit

May 3, 2022

Conditions

Keywords

dietary supplementsnitrateneuromuscular function

Outcome Measures

Primary Outcomes (5)

  • Changes in maximal isometric handgrip strength (N)

    Using a dynamometer and measuring dominant/ non-dominant side

    1-week

  • Changes in 6-m gait speed test

    Using a photocell timing gates (seconds)

    1-week

  • Changes in Time Up and Go test

    Using a photocell timing gates (seconds)

    1-week

  • Changes in Sit and Stand Test

    Using Power Frail APP

    1-week

  • 6-Minute Walk Test

    1-week

Secondary Outcomes (2)

  • Rate of perception effort (RPE)

    1-week

  • Side effects questionnarie

    1-week

Study Arms (2)

Beetroot supplementation

EXPERIMENTAL

One serving 70 mL of beetroot juice (6.4 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) 3 h before initiating the testing session.

Dietary Supplement: beetroot juice

Placebo supplementation

PLACEBO COMPARATOR

One serving 70 mL of beetroot juice placebo (0.04 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) 3 h before initiating the testing session.

Dietary Supplement: beetroot juice

Interventions

beetroot juiceDIETARY_SUPPLEMENT

Acute effects of beetroot juice or placebo juice ingestion

Beetroot supplementationPlacebo supplementation

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women older adults were selected for this study.
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women \>65 or \<85 years of age.
  • In good health, as determined by the investigator's review of history.

You may not qualify if:

  • Men and women \<65 or \>85 years of age Unable to provide informed consent Current smokers Significant orthopedic limitations or other contraindications to strenuous exercise Those taking proton pump inhibitors, antacids, xanthine oxidase inhibitors, or on hormone replacement therapy Those taking anti-coagulants or on anti-platelet therapy History of neuromuscular disease (e.g., cervical spondylotic radiculomyelpathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies) Cardiovascular disease (e.g., \> stage I hypertension, heart failure, myocardial infarction/ischemia significant myocardial or pericardial diseases (e.g. amyloidosis, constriction), Moderate or severe valvular disease, renal disease, liver disease, or anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Study Officials

  • Alvaro López Samanes, PhD

    Universidad Francisco de Vitoria

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 13, 2022

First Posted

April 20, 2022

Study Start

March 1, 2022

Primary Completion

March 18, 2022

Study Completion

April 10, 2022

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations