Clinical trial NCT02772900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Hypertension
Dyslipidemia
Abdominal Obesity
Keywords: Aging
Beetroot
Dietary Nitrate
Functional Food
Vascular Function
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2016-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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.

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