Postmenopausal; MenorrhagiaNCT05820321
Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women
A study testing Beetroot juice rich in nitrate and Beetroot juice NO3 depleted in people with Postmenopausal; Menorrhagia and Physical Inactivity, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Postmenopausal; Menorrhagia, Physical Inactivity, Motor Activity
- What is being tested?
- Beetroot juice rich in nitrate and Beetroot juice NO3 depleted
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jul 2022to 31 Dec 2023
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 to 65 years old
- Physically inactive
- Postmenopausal diagnosis (amenorrhea for 12 months or more);
Who cannot join
- Smoking
- Cardiac failure
- Previous history of acute myocardial infarction and/or stroke;
- Allergy or intolerance to nitrate, gluten, or milk;
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Cicero Jonas Rodrigues Benjamim
Ribeirão Preto, São Paulo, 05508-900
Cicero JR Benjamim, 07775453372, jonasbenjamim@usp.br
- Recruiting
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, São Paulo
Cicero Jonas R. Benjamim, PhD Student, 87988621194, benjamim.nutricao@gmail.com
About this study
Official title: Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women: a Randomized Trial
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.
- Being tested
- Beetroot juice rich in nitrate, Beetroot juice NO3 depleted
- Medical subject headings
- Menorrhagia, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Beetroot juice NO3) | Active comparator | 8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days. Receives: 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. Receives: Other: Beetroot juice NO3 depleted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength test (kgf)
Measured: up to 2 years
Secondary outcomes (4)
Six minute walk test (distance in meters)
Measured: up to 2 years
Arm curl test (repetitions)
Measured: up to 2 years
Sit-to-stand test (repetitions)
Measured: up to 2 years
8-foot up and go test (seconds)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Jul 2022
- Primary completion20 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal; MenorrhagiaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas R Benjamim, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820321
- Sponsor's protocol ID
- BEET-MS
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38805867
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05820321
- Acronym / sponsor ID
- BEET-MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Apr 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Beetroot juice NO3) | Active comparator | Dietary Supplement: Beetroot juice rich in nitrate8-day supplementation with beetroot juice rich in NO3 (400mg) during 8 days. |
| Placebo (Beetroot juice without NO3) | Placebo comparator | Other: Beetroot juice NO3 depleted8-day supplementation with beetroot juice NO3 depleted during 8 days. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 to 65 years old
- Physically inactive
- Postmenopausal diagnosis (amenorrhea for 12 months or more);
Key exclusion criteria (4 listed)
- Smoking
- Cardiac failure
- Previous history of acute myocardial infarction and/or stroke;
- Allergy or intolerance to nitrate, gluten, or milk;
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 juice rich in nitrateThe 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. | Dietary supplement | Experimental (Beetroot juice NO3) |
| Beetroot juice NO3 depletedThe 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. | Other | Placebo (Beetroot juice without NO3) |
Primary outcome
Handgrip strength test (kgf)
Time frame: up to 2 years
4 secondary outcomes
Six minute walk test (distance in meters)
Time frame: up to 2 years
Arm curl test (repetitions)
Time frame: up to 2 years
Sit-to-stand test (repetitions)
Time frame: up to 2 years
8-foot up and go test (seconds)
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 38805867Benjamim 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.
- Individual participant dataSharing planned: Undecided
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.
EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
Ribeirão Preto, Brazil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice rich in nitrate and Beetroot juice NO3 depleted in people with Postmenopausal; Menorrhagia and Physical Inactivity, run by University of Sao Paulo at 2 sites in Brazil.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strength test (kgf) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820321, which also lists 1 linked publication.
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 13 Jun 2023.