- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05337527
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults (BEET_ELDERLY)
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults. Performance and Side Effects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spain, 28223
- Universidad Francisco de Vitoria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women >65 or <85 years of age.
- In good health, as determined by the investigator's review of history.
Exclusion Criteria: (based in previous studies on this topic (doi: 10.1093/gerona/glaa311).
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beetroot supplementation
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.
|
Acute effects of beetroot juice or placebo juice ingestion
|
Placebo Comparator: Placebo supplementation
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.
|
Acute effects of beetroot juice or placebo juice ingestion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in maximal isometric handgrip strength (N)
Time Frame: 1-week
|
Using a dynamometer and measuring dominant/ non-dominant side
|
1-week
|
Changes in 6-m gait speed test
Time Frame: 1-week
|
Using a photocell timing gates (seconds)
|
1-week
|
Changes in Time Up and Go test
Time Frame: 1-week
|
Using a photocell timing gates (seconds)
|
1-week
|
Changes in Sit and Stand Test
Time Frame: 1-week
|
Using Power Frail APP
|
1-week
|
6-Minute Walk Test
Time Frame: 1-week
|
1-week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of perception effort (RPE)
Time Frame: 1-week
|
Using a validated scale (1-10 points)
|
1-week
|
Side effects questionnarie
Time Frame: 1-week
|
Using a side-effects questionnarie (YES/NO scale)
|
1-week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alvaro López Samanes, PhD, Universidad Francisco de Vitoria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- uFrancisco_Vitoria_
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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