PregnancyNCT03315806
Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation
A study testing Beetroot juice in people with Pregnancy, run by Universidade Federal do Rio de Janeiro.
Trial summary
Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2016to 19 May 2017
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gestation between 20 and 35 weeks;
- over 18 years
Who cannot join
- diabetes mellitus and gestational diabetes;
- hypertensive syndromes;
- HIV positive;
- liver or kidney disease;
- beetroot allergy;
- use of antioxidants and medicament that alter endothelial function;
- use of antibiotics up to 2 weeks before the visits and using.
About this study
Official title: Effect of Beetroot Juice Consumption on Endothelial Function and Tissue Oxygen Saturation in Pregnant
Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA) interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120 min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after interventions.
- Conditions
- Pregnancy
- Being tested
- Beetroot juice, Placebo
- Keywords
- Dietary nitrate, Nitrate, Flow-mediated dilation, Tissue oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceOther
140 mL of beetroot juice cointaning approximately 9 mmol of nitrate
PlaceboOther
140 mL of beetroot juice isent of nitrate
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice | Active comparator | Beetroot juice containing 9 mmol of nitrate per dose Receives: Other: Beetroot juice |
| Placebo juice (nitrate depleted) | Placebo comparator | Beetroot juice nitrate-depleted Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macro endothelial function
Flow-mediated dilation (FMD)
Measured: Evaluated 120 minutes after the nutritional intervention
Micro endothelial function
Tissue oxygen saturation parameters
Measured: Evaluated 140 minutes after the nutritional intervention
Nitrate urinary
Measured: Evaluated 150 minutes after the nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start6 Oct 2016
- Primary completion14 Feb 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315806
- Sponsor's protocol ID
- 56732216.5.0000.5699
- Status last verified
- Nov 2017
- First submitted
- 16 Oct 2017
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beetroot Juice Consumption on Endothelial Function and Tissue Oxygen Saturation in Pregnant
- ClinicalTrials.gov ID
- NCT03315806
- Acronym / sponsor ID
- 56732216.5.0000.5699
- Conditions
- Pregnancy
- Keywords
- Dietary nitrate, Nitrate, Flow-mediated dilation, Tissue oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 20 Oct 2017 (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.
Adequate macro and microvascular endothelial function during pregnancy is essential for the normal placental development and growing fetus. Beetroot juice (BJ) promotes improvement ins this parameters in no-pregnant individuals, however the beneficial effect did not avaliated in pregnant. The present study evaluated effects of BJ on macro and microvascular endothelial function in pregnant. Twelve pregnant were submitted to BJ and nitrate-depleted juice (PLA) interventions. Brachial flow-mediated dilation (FMD) and muscle oxygenation were measured 120 min after interventions. Urinary nitrate, nitrite were measured at baseline and 120 min after interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice | Active comparator | Other: Beetroot juiceBeetroot juice containing 9 mmol of nitrate per dose |
| Placebo juice (nitrate depleted) | Placebo comparator | Other: PlaceboBeetroot juice nitrate-depleted |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- gestation between 20 and 35 weeks;
- over 18 years
Key exclusion criteria (7 listed)
- diabetes mellitus and gestational diabetes;
- hypertensive syndromes;
- HIV positive;
- liver or kidney disease;
- beetroot allergy;
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 juice140 mL of beetroot juice cointaning approximately 9 mmol of nitrate | Other | Beetroot Juice |
| Placebo140 mL of beetroot juice isent of nitrate | Other | Placebo juice (nitrate depleted) |
Primary outcome
Macro endothelial function
Time frame: Evaluated 120 minutes after the nutritional intervention
Flow-mediated dilation (FMD)
Micro endothelial function
Time frame: Evaluated 140 minutes after the nutritional intervention
Tissue oxygen saturation parameters
Nitrate urinary
Time frame: Evaluated 150 minutes after the nutritional intervention
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 18 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice in people with Pregnancy, run by Universidade Federal do Rio de Janeiro.
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 2 inclusion and 7 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Macro endothelial function (time frame: Evaluated 120 minutes after the nutritional intervention). The study lists 3 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 18 Dec 2024.