Aging, Nitrate, Endothelial Function and Muscle Oxygenation

Study Overview
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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.

Official Title
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Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk

Conditions
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Aging, Hypertension, Dyslipidemia, Abdominal Obesity

Intervention / Treatment
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* Other: Beetroot-based nutritional gel
* Other: Placebo


Participation Criteria
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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). 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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Beetroot gel (dietary nitrate)<br>Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose | Other: Beetroot-based nutritional gel<br>* 100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.<br>|
| Active Comparator: Placebo gel (nitrate-depleted)<br>Nutritional gel nitrate-depleted | Other: Placebo<br>* 100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in endothelial function as evaluated by the flow-mediated dilation. |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the arterial stiffness as evaluated by the peak wave velocity. |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the clinical blood pressure |  | Evaluated before, 120 min and 180 min after the nutritional intervention | 
| Changes in the muscle oxygenation as evaluated by the levels of oxygenated |  | Evaluated 150 min after the nutritional intervention | 
| Changes in the muscle function as evaluated by the maximal voluntary contraction of the forearm muscle |  | Evaluated before and 180 min after the nutritional intervention | 
| Changes in endothelial function as evaluated by blood flow velocity |  | Evaluated 120 min after the nutritional intervention | 
| Changes in endothelial function as evaluated by reactive hyperemia. |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the arterial stiffness as evaluated by augmentation index |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the arterial stiffness as evaluated by the stiffness parameter |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the arterial stiffness as evaluated by the arterial compliance. |  | Evaluated 120 min after the nutritional intervention | 
| Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin |  | Evaluated 150 min after the nutritional intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Beetroot, Dietary Nitrate, Functional Food, Vascular Function