Aging, Nitrate, Endothelial Function and Muscle Oxygenation

NCT ID: NCT02772900

Last Updated: 2016-05-17

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-01-31

Brief Summary

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Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO bioconversion, which may promote beneficial effects on vascular health. The present study evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ), augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), muscle oxygenation and function were measured 90 min after interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after interventions.

Detailed Description

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Conditions

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Aging Hypertension Dyslipidemia Abdominal Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Beetroot gel (dietary nitrate)

Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose

Group Type ACTIVE_COMPARATOR

Beetroot-based nutritional gel

Intervention Type OTHER

100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.

Placebo gel (nitrate-depleted)

Nutritional gel nitrate-depleted

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

Interventions

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Beetroot-based nutritional gel

100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.

Intervention Type OTHER

Placebo

100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Elderly participants (≥ 65 years)
* Taking between 1 and 3 anti-hypertensive medications for high blood pressure;
* Elevated triglycerides ≥ 150 mg/dL;
* Reduced HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men;
* Elevated waist circumference by population definition (male: \> 102 cm and female: \> 88 cm).
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

D.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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15510313.5.0000.5257

Identifier Type: -

Identifier Source: org_study_id

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