Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

This single-arm, open-label study will assess the safety and tolerability of one daily tablet of a commercially available cardiovascular health dietary supplement by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Although the cardiovascular health dietary supplement being investigated has been on the market for over 20 years, prospective safety data and blood markers of end organ function have not previously been reported.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Cardiovascular health dietary supplement

Detailed Description

Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events, including myocardial infarction and stroke, and cardiovascular-related mortality with advancing age. Based on population based studies and clinical trials, both systolic blood pressure (SBP) and diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors for cardiovascular disease.

The product being studies is a cardiovascular health dietary supplement that has been commercially available since 1993. It is currently sold to healthcare practitioners as well as directly to consumers. Some healthcare providers use the product as part of a plan to treat high blood pressure in their patients. This is the first study collecting prospective safety data on this product.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Helfgott Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18-65
• Systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg upon screening

Exclusion Criteria:

• Bradycardia
• Initiation of or changes to blood pressure lowering medications within the last month
• Initiation of or changes to thyroid medications within the last month

• Currently taking any of the following orally (or they were taken within the last month):

  • Rauwolfia serpentina, Terminalia arjuna, Tribulus terrestris, Convolvulus pluricaulis, Boerhavia diffusa, Rosa vinca, rose powder, or coral powder
  • Beta blockers
  • Alpha blockers
  • Propranolol
  • Digoxin
  • Levodopa
  • Anti-depressant medications
  • Anti-psychotic medications
  • Sedatives or tranquilizers

• Present or past history of any of the following:

  • Cardiovascular disease
  • Heart surgery
  • Cardiac arrhythmia
  • Abnormal EKG
  • Abnormal echocardiogram
  • Diabetes
  • Chronic liver, kidney or bowel disease
  • Ulcers
  • Gallbladder disease
  • Depression
  • Alcoholism
  • Obstructive sleep apnea and/or use of a continuous positive airway pressure device
  • Parkinson's disease
  • Pheochromocytoma
  • Cancer within the last 5 years
• Consuming more than fourteen alcoholic beverages per week
• Current smoking/tobacco use
• Current illicit and/or recreational drug use
• Women who are lactating, pregnant or planning pregnancy within the next six months
• Known intolerance or allergy to study agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiovascular Health Dietary Supplement; The cardiovascular health dietary supplement will be administered at a dosage of 1 caplet po per day for a period of 6 months	Dietary supplement: Cardiovascular health dietary supplement; Herbal/mineral dietary supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of a cardiovascular health dietary supplement assessed by composite changes in multi-system symptoms, a validated mood/depression questionnaire, electrolytes, and surrogate markers of heart, liver and kidney function	Standardized adverse event monitoring form, Patient Health Questionnaire (PHQ-9), electrolytes (sodium, potassium, calcium, magnesium), b-type natriuretic peptide, aspartate aminotransferase, alanine aminotransferase, and estimated glomerular filtration rate	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Investigators: Principal Investigator: Jennifer J Ryan, ND, MS, National University of Natural Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): July 28, 2017
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB042115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No