Dietary SupplementBEET_ELDERLYNCT05337527
Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults
A study testing beetroot juice in people with Dietary Supplement and Placebo, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement, Placebo
- What is being tested?
- beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 10 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults. Performance and Side Effects
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
Read the detailed description
Beetroot juice supplementation has shown the capacity for provoking different physiological effects that could affect human performance (e.g. vasodilation and muscle contraction increments). Although this dietary supplement has been commonly used for improving sports performance in recreational or professional athletes, the scientific literature in older adults is scarce. Thus, in our knowledge, no previous studies have analyzed the side effects associated to ingestion in this population group. In this randomized placebo-controlled study, we investigated the effects of beetroot acute supplementation in improving neuromuscular performance and side effects associated with ingestion in women older adults.
- Conditions
- Dietary Supplement, Placebo
- Being tested
- beetroot juice
- Keywords
- dietary supplements, nitrate, neuromuscular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beetroot juiceDietary supplement
Acute effects of beetroot juice or placebo juice ingestion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal isometric handgrip strength (N)
Using a dynamometer and measuring dominant/ non-dominant side
Measured: 1-week
Changes in 6-m gait speed test
Using a photocell timing gates (seconds)
Measured: 1-week
Changes in Time Up and Go test
Using a photocell timing gates (seconds)
Measured: 1-week
Changes in Sit and Stand Test
Using Power Frail APP
Measured: 1-week
6-Minute Walk Test
Measured: 1-week
Secondary outcomes (2)
Rate of perception effort (RPE)
Using a validated scale (1-10 points)
Measured: 1-week
Side effects questionnarie
Using a side-effects questionnarie (YES/NO scale)
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Mar 2022
- Primary completion18 Mar 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Álvaro López Samanés, Universidad Francisco de Vitoria
- Investigators
- Alvaro López Samanes, PhD, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337527
- Sponsor's protocol ID
- uFrancisco_Vitoria_
- Acronym
- BEET_ELDERLY
- Status last verified
- May 2022
- First submitted
- 13 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Responses to Acute Beetroot Ingestion in Women Older Adults. Performance and Side Effects
- ClinicalTrials.gov ID
- NCT05337527
- Acronym / sponsor ID
- BEET_ELDERLY / uFrancisco_Vitoria_
- Conditions
- Dietary Supplement, Placebo
- Keywords
- dietary supplements, nitrate, neuromuscular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Beetroot juice supplementation has shown the capacity for provoking different physiological effects that could affect human performance (e.g. vasodilation and muscle contraction increments). Although this dietary supplement has been commonly used for improving sports performance in recreational or professional athletes, the scientific literature in older adults is scarce. Thus, in our knowledge, no previous studies have analyzed the side effects associated to ingestion in this population group. In this randomized placebo-controlled study, we investigated the effects of beetroot acute supplementation in improving neuromuscular performance and side effects associated with ingestion in women older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot supplementation | Experimental | Dietary Supplement: beetroot juiceOne 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. |
| Placebo supplementation | Placebo comparator | Dietary Supplement: beetroot juiceOne 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beetroot juiceAcute effects of beetroot juice or placebo juice ingestion | Dietary supplement | Beetroot supplementation, Placebo supplementation |
Primary outcome
Changes in maximal isometric handgrip strength (N)
Time frame: 1-week
Using a dynamometer and measuring dominant/ non-dominant side
Changes in 6-m gait speed test
Time frame: 1-week
Using a photocell timing gates (seconds)
Changes in Time Up and Go test
Time frame: 1-week
Using a photocell timing gates (seconds)
Changes in Sit and Stand Test
Time frame: 1-week
Using Power Frail APP
6-Minute Walk Test
Time frame: 1-week
2 secondary outcomes
Rate of perception effort (RPE)
Time frame: 1-week
Side effects questionnarie
Time frame: 1-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvaro López Samanes, PhD principal investigator
Universidad Francisco de Vitoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beetroot juice in people with Dietary Supplement and Placebo, run by Universidad Francisco de Vitoria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in maximal isometric handgrip strength (N) (time frame: 1-week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.