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
About this trial
This is an interventional prevention trial for Aging focused on measuring Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function
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.
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
NCT ID
NCT02772900
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)
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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