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Aging, Nitrate, Endothelial Function and Muscle Oxygenation

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ClinicalTrials.gov Identifier: NCT02772900
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Thiago Alvares, Universidade Federal do Rio de Janeiro

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aging Hypertension Dyslipidemia Abdominal Obesity Other: Beetroot-based nutritional gel Other: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Beetroot gel (dietary nitrate)
Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose
 Other: Beetroot-based nutritional gel
100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
Active Comparator: Placebo gel (nitrate-depleted)
Nutritional gel nitrate-depleted
 Other: Placebo
100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in endothelial function as evaluated by the flow-mediated dilation. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  2. Changes in the arterial stiffness as evaluated by the peak wave velocity. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  3. Changes in the clinical blood pressure [ Time Frame: Evaluated before, 120 min and 180 min after the nutritional intervention ]
  4. Changes in the muscle oxygenation as evaluated by the levels of oxygenated [ Time Frame: Evaluated 150 min after the nutritional intervention ]
  5. 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 ]
  6. Changes in endothelial function as evaluated by blood flow velocity [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  7. Changes in endothelial function as evaluated by reactive hyperemia. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  8. Changes in the arterial stiffness as evaluated by augmentation index [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  9. Changes in the arterial stiffness as evaluated by the stiffness parameter [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  10. Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  11. Changes in the arterial stiffness as evaluated by the arterial compliance. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  12. Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin [ Time Frame: Evaluated 150 min after the nutritional intervention ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Thiago Alvares, D.Sc., Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02772900    
Other Study ID Numbers: 15510313.5.0000.5257
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by Thiago Alvares, Universidade Federal do Rio de Janeiro:
Aging
Beetroot
Dietary Nitrate
Functional Food
Vascular Function
Additional relevant MeSH terms:
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Dyslipidemias
Obesity, Abdominal
Lipid Metabolism Disorders
Metabolic Diseases
Obesity
 Overweight
Overnutrition
Nutrition Disorders
Body Weight