Clinical trial NCT02452749: Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
Official title: Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Helfgott Research Institute
state: Oregon
Study officials:
affiliation: National University of Natural Medicine
name: Jennifer J Ryan, ND, MS
role: PRINCIPAL_INVESTIGATOR
References: