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Aging, Nitrate, Endothelial Function and Muscle Oxygenation

Primary Purpose

Aging, Hypertension, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Beetroot-based nutritional gel
Placebo
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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).

Exclusion Criteria: elevated fasting glucose (≥ 100 mg/dL), smoking, beetroot allergy, unwillingness to avoid beetroot products during the entire study, other chronic diseases (diabetes, liver disease, etc.), or acutely ill.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Beetroot gel (dietary nitrate)

    Placebo gel (nitrate-depleted)

    Arm Description

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

    Nutritional gel nitrate-depleted

    Outcomes

    Primary Outcome Measures

    Changes in endothelial function as evaluated by the flow-mediated dilation.
    Changes in the arterial stiffness as evaluated by the peak wave velocity.
    Changes in the clinical blood pressure
    Changes in the muscle oxygenation as evaluated by the levels of oxygenated
    Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle
    Changes in endothelial function as evaluated by blood flow velocity
    Changes in endothelial function as evaluated by reactive hyperemia.
    Changes in the arterial stiffness as evaluated by augmentation index
    Changes in the arterial stiffness as evaluated by the stiffness parameter
    Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus
    Changes in the arterial stiffness as evaluated by the arterial compliance.
    Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin

    Secondary Outcome Measures

    Full Information

    First Posted
    May 2, 2016
    Last Updated
    May 15, 2016
    Sponsor
    Universidade Federal do Rio de Janeiro
    Collaborators
    Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02772900
    Brief Title
    Aging, Nitrate, Endothelial Function and Muscle Oxygenation
    Official Title
    Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro
    Collaborators
    Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Hypertension, Dyslipidemia, Abdominal Obesity
    Keywords
    Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Beetroot gel (dietary nitrate)
    Arm Type
    Active Comparator
    Arm Description
    Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose
    Arm Title
    Placebo gel (nitrate-depleted)
    Arm Type
    Active Comparator
    Arm Description
    Nutritional gel nitrate-depleted
    Intervention Type
    Other
    Intervention Name(s)
    Beetroot-based nutritional gel
    Intervention Description
    100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.
    Primary Outcome Measure Information:
    Title
    Changes in endothelial function as evaluated by the flow-mediated dilation.
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the arterial stiffness as evaluated by the peak wave velocity.
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the clinical blood pressure
    Time Frame
    Evaluated before, 120 min and 180 min after the nutritional intervention
    Title
    Changes in the muscle oxygenation as evaluated by the levels of oxygenated
    Time Frame
    Evaluated 150 min after the nutritional intervention
    Title
    Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle
    Time Frame
    Evaluated before and 180 min after the nutritional intervention
    Title
    Changes in endothelial function as evaluated by blood flow velocity
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in endothelial function as evaluated by reactive hyperemia.
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the arterial stiffness as evaluated by augmentation index
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the arterial stiffness as evaluated by the stiffness parameter
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the arterial stiffness as evaluated by the arterial compliance.
    Time Frame
    Evaluated 120 min after the nutritional intervention
    Title
    Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin
    Time Frame
    Evaluated 150 min after the nutritional intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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). Exclusion Criteria: elevated fasting glucose (≥ 100 mg/dL), smoking, beetroot allergy, unwillingness to avoid beetroot products during the entire study, other chronic diseases (diabetes, liver disease, etc.), or acutely ill.

    12. IPD Sharing Statement

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    Aging, Nitrate, Endothelial Function and Muscle Oxygenation

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