NCT03909789

Brief Summary

The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

November 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

April 8, 2019

Last Update Submit

April 10, 2019

Conditions

Blood PressureEndothelial Dysfunction

Keywords

Endothelium

Outcome Measures

Primary Outcomes (1)

  • Rate of change in blood pressure

    change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo

    12 weeks

Secondary Outcomes (2)

  • changes in serum, plasma and salivary Nitrite and Nitrate

    12 weeks

  • cardiometabolic relevant biomarkers (as compared to placebo)

    12 weeks

Study Arms (2)

plant based bioequivalent dietary nitrate supplement

ACTIVE COMPARATOR

The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.

Dietary Supplement: Plant based bioequivalent Nitrate supplementation

placebo

PLACEBO COMPARATOR

The Placebo does not contain any nitric oxide supplement.

Dietary Supplement: Placebo

Interventions

Plant based bioequivalent Nitrate supplementationDIETARY_SUPPLEMENT

The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.

plant based bioequivalent dietary nitrate supplement
PlaceboDIETARY_SUPPLEMENT

Placebo

placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 40-75 years
  • Hypertension \>130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
  • Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them

You may not qualify if:

  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
  • Weight in excess of 250 pounds
  • Bleeding disorder
  • History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
  • NYHA Class II- IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
  • Serum creatinine \> 1.4 mg/dl
  • Triglycerides \> 400 at visit 1
  • Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
  • Concurrent enrollment in another placebo-controlled trial
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • Current tobacco use
  • Current use of anticoagulants (except for anti-platelet agents)
  • Renal failure
  • History of hypertensive encephalopathy or cerebrovascular accident
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (1)

  • Cherukuri L, Birudaraju D, Kinninger A, Chaganti BT, Shekar C, Hamal S, Shaikh K, Flores F, Roy SK, Sotka W, Green SJ, Budoff MJ. Effect of a plant-based bioequivalent inorganic nitrate (NO3-) complex with vitamins, antioxidants and phytophenol rich food extracts in hypertensive individuals - A randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Dec;40:327-335. doi: 10.1016/j.clnesp.2020.08.007. Epub 2020 Sep 7.

    PMID: 33183558DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double Blind Placebo Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 10, 2019

Study Start

November 17, 2017

Primary Completion

June 22, 2018

Study Completion

June 22, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

US(1)