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Exploring the Effect of Inorganic Nitrates on the Human Microvascular Physiology - a Pilot Study.

NCT04276766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-02-19

No results posted yet for this study

Summary

We conducted a randomised, placebo-controlled, double blind, cross-over, trial to examine the short-term effect of concentrated beetroot juice on vascular outcomes in a young (18-35 years) and older group (55-75 years). The study included a run-in period of one day preceding the test day. A wash-out period of at least 7 days was implemented to ensure to avoid a carry-over effect of the interventions.

Conditions

  • Aging

Interventions

OTHER

Crossover intervention

Drink consumption was followed by regular BP measurements and collection of saliva samples every 30 minutes for four hours. Microcirculatory measurements were then repeated and saliva and urine samples were collected again. After the last measurement subjects were provided with a standardized meal with a very low nitrate intake to eat within 30minutes. Participant then left the research centre and they were asked to collect a saliva sample after two hours from the completion of the meal. This was immediately followed a dose of labelled nitrate (4mg in 100ml of distilled water) to drink within one minute. Subjects were then asked to collect six additional saliva samples until the next morning (four before going to bed and two in the morning), accompanied by measurements of resting BP. Cross-over assessments were then repeated in the same order at Visit 3, followed a wash-out period of at least one week before entering the second arm of the study.

Sponsors & Collaborators

  • University of Sheffield

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • Sheffield Hallam University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2016-12-01
Completion
2018-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276766 on ClinicalTrials.gov