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Pregnancy, Nitrate, Endothelial Function and Tissue Oxygen Saturation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03315806
Recruitment Status : Completed
First Posted : October 20, 2017
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Thiago Alvares, Universidade Federal do Rio de Janeiro

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Beetroot juice Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Prevention
Official Title: Effect of Beetroot Juice Consumption on Endothelial Function and Tissue Oxygen Saturation in Pregnant
Actual Study Start Date : October 6, 2016
Actual Primary Completion Date : February 14, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Beetroot Juice
Beetroot juice containing 9 mmol of nitrate per dose
Other: Beetroot juice
140 mL of beetroot juice cointaning approximately 9 mmol of nitrate

Placebo Comparator: Placebo juice (nitrate depleted)
Beetroot juice nitrate-depleted
Other: Placebo
140 mL of beetroot juice isent of nitrate

Primary Outcome Measures :
  1. Macro endothelial function [ Time Frame: Evaluated 120 minutes after the nutritional intervention ]
    Flow-mediated dilation (FMD)

  2. Micro endothelial function [ Time Frame: Evaluated 140 minutes after the nutritional intervention ]
    Tissue oxygen saturation parameters

  3. Nitrate urinary [ Time Frame: Evaluated 150 minutes after the nutritional intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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Responsible Party: Thiago Alvares, PhD, Universidade Federal do Rio de Janeiro Identifier: NCT03315806     History of Changes
Other Study ID Numbers: 56732216.5.0000.5699
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thiago Alvares, Universidade Federal do Rio de Janeiro:
Dietary nitrate
Flow-mediated dilation
Tissue oxygen saturation