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Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation

NCT ID: NCT03315806

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-06

Study Completion Date

2017-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Keywords

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Dietary nitrate Nitrate Flow-mediated dilation Tissue oxygen saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double blind

Study Groups

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Beetroot Juice

Beetroot juice containing 9 mmol of nitrate per dose

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type OTHER

140 mL of beetroot juice cointaning approximately 9 mmol of nitrate

Placebo juice (nitrate depleted)

Beetroot juice nitrate-depleted

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

140 mL of beetroot juice isent of nitrate

Interventions

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Beetroot juice

140 mL of beetroot juice cointaning approximately 9 mmol of nitrate

Intervention Type OTHER

Placebo

140 mL of beetroot juice isent of nitrate

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* gestation between 20 and 35 weeks;
* over 18 years

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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56732216.5.0000.5699

Identifier Type: -

Identifier Source: org_study_id