NCT02772900

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 2, 2016

Last Update Submit

May 15, 2016

Conditions

AgingHypertensionDyslipidemiaAbdominal Obesity

Keywords

AgingBeetrootDietary NitrateFunctional FoodVascular Function

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

Beetroot gel (dietary nitrate)

ACTIVE COMPARATOR

Beetroot-based nutritional gel containing approximately 10.0 mmol of nitrate per dose

Other: Beetroot-based nutritional gel

Placebo gel (nitrate-depleted)

ACTIVE COMPARATOR

Nutritional gel nitrate-depleted

Other: Placebo

Interventions

Beetroot-based nutritional gelOTHER

100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.

Beetroot gel (dietary nitrate)
PlaceboOTHER

100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.

Placebo gel (nitrate-depleted)

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDyslipidemiasObesity, Abdominal

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
D.Sc.

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 16, 2016

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05