Aging, Nitrate, Endothelial Function and Muscle Oxygenation

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772900
• Other study ID #: 15510313.5.0000.5257
• Status: Completed
• Phase: N/A
• First received: May 2, 2016
• Last updated: May 11, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: May 2016
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abdominal Obesity
• Aging
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity, Abdominal

Intervention

Other:
• Beetroot-based nutritional gel
100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
• Placebo
100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in endothelial function as evaluated by the flow-mediated dilation.		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the arterial stiffness as evaluated by the peak wave velocity.		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the clinical blood pressure		Evaluated before, 120 min and 180 min after the nutritional intervention	Yes
Primary	Changes in the muscle oxygenation as evaluated by the levels of oxygenated and deoxygenated hemoglobin		Evaluated 150 min after the nutritional intervention	Yes
Primary	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	Yes
Primary	Changes in endothelial function as evaluated by blood flow velocity		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in endothelial function as evaluated by reactive hyperemia.		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the arterial stiffness as evaluated by augmentation index		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the arterial stiffness as evaluated by the stiffness parameter		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the arterial stiffness as evaluated by the pressure-strain elasticity modulus		Evaluated 120 min after the nutritional intervention	Yes
Primary	Changes in the arterial stiffness as evaluated by the arterial compliance.		Evaluated 120 min after the nutritional intervention	Yes