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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

Tracking Information
First Submitted Date  ICMJE May 2, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2016)
  • Changes in endothelial function as evaluated by the flow-mediated dilation. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the peak wave velocity. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the clinical blood pressure [ Time Frame: Evaluated before, 120 min and 180 min after the nutritional intervention ]
  • Changes in the muscle oxygenation as evaluated by the levels of oxygenated [ Time Frame: Evaluated 150 min after the nutritional intervention ]
  • 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 ]
  • Changes in endothelial function as evaluated by blood flow velocity [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in endothelial function as evaluated by reactive hyperemia. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by augmentation index [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the stiffness parameter [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the arterial compliance. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the muscle oxygenation as evaluated by the levels of deoxygenated hemoglobin [ Time Frame: Evaluated 150 min after the nutritional intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Changes in endothelial function as evaluated by the flow-mediated dilation. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the peak wave velocity. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the clinical blood pressure [ Time Frame: Evaluated before, 120 min and 180 min after the nutritional intervention ]
  • Changes in the muscle oxygenation as evaluated by the levels of oxygenated and deoxygenated hemoglobin [ Time Frame: Evaluated 150 min after the nutritional intervention ]
  • 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 ]
  • Changes in endothelial function as evaluated by blood flow velocity [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in endothelial function as evaluated by reactive hyperemia. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by augmentation index [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the stiffness parameter [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus [ Time Frame: Evaluated 120 min after the nutritional intervention ]
  • Changes in the arterial stiffness as evaluated by the arterial compliance. [ Time Frame: Evaluated 120 min after the nutritional intervention ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aging, Nitrate, Endothelial Function and Muscle Oxygenation
Official Title  ICMJE Effect of a Beetroot-based Nutritional Gel on Vascular Function and Forearm Muscle Oxygenation Responses in the Elderly at Cardiometabolic Risk
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Aging
  • Hypertension
  • Dyslipidemia
  • Abdominal Obesity
Intervention  ICMJE
  • Other: Beetroot-based nutritional gel
    100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
  • Other: Placebo
    100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.
Study Arms  ICMJE
  • Active Comparator: Beetroot gel (dietary nitrate)
    Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose
    Intervention: Other: Beetroot-based nutritional gel
  • Active Comparator: Placebo gel (nitrate-depleted)
    Nutritional gel nitrate-depleted
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02772900
Other Study ID Numbers  ICMJE 15510313.5.0000.5257
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thiago Alvares, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Rio de Janeiro
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP