NCT03315806

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable pregnancy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
Last Updated

December 18, 2024

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

October 16, 2017

Last Update Submit

December 15, 2024

Conditions

Pregnancy

Keywords

Dietary nitrateNitrateFlow-mediated dilationTissue oxygen saturation

Outcome Measures

Primary Outcomes (3)

  • Macro endothelial function

    Flow-mediated dilation (FMD)

    Evaluated 120 minutes after the nutritional intervention

  • Micro endothelial function

    Tissue oxygen saturation parameters

    Evaluated 140 minutes after the nutritional intervention

  • Nitrate urinary

    Evaluated 150 minutes after the nutritional intervention

Study Arms (2)

Beetroot Juice

ACTIVE COMPARATOR

Beetroot juice containing 9 mmol of nitrate per dose

Other: Beetroot juice

Placebo juice (nitrate depleted)

PLACEBO COMPARATOR

Beetroot juice nitrate-depleted

Other: Placebo

Interventions

Beetroot juiceOTHER

140 mL of beetroot juice cointaning approximately 9 mmol of nitrate

Beetroot Juice
PlaceboOTHER

140 mL of beetroot juice isent of nitrate

Placebo juice (nitrate depleted)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 20, 2017

Study Start

October 6, 2016

Primary Completion

February 14, 2017

Study Completion

May 19, 2017

Last Updated

December 18, 2024

Record last verified: 2017-11