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Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

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ClinicalTrials.gov Identifier: NCT01331486
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prehypertension and mild hypertension affect an estimated 157 million U.S. adults. Cardiovascular disease (CVD) risk and associated mortality is elevated in this population. Treatment options are limited consisting of lifestyle modification, which is often ineffective, or drug therapy, which carries risk of side effects. Highly safe, efficacious, and acceptable treatment options for this population are needed. Hawthorn standardized extract (HSE) is approved for use in Europe to treat heart failure, and preliminary evidence suggests it may have a blood pressure lowering effect. However, prior trials of hawthorn have based dosage recommendations on animal studies. Therefore, the investigators propose a dose-finding study to measure the pharmacodynamic effect of three doses of standardized hawthorn extract and placebo.

Condition or disease Intervention/treatment Phase
Prehypertension Mild Hypertension Dietary Supplement: Hawthorn Dietary Supplement: Placebo capsule Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract
Study Start Date : May 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsule
Dietary Supplement: Placebo capsule
Matched placebo liquid capsule
Active Comparator: Low dose Dietary Supplement: Hawthorn
Hawthorn standardized extract liquid capsule
Other Name: Gaia Hawthorn Supreme
Active Comparator: Mid dose Dietary Supplement: Hawthorn
Hawthorn standardized extract liquid capsule
Other Name: Gaia Hawthorn Supreme
Active Comparator: High dose Dietary Supplement: Hawthorn
Hawthorn standardized extract liquid capsule
Other Name: Gaia Hawthorn Supreme


Outcome Measures

Primary Outcome Measures :
  1. FMD Max [ Time Frame: 7d ]
    Brachial artery flow mediated dilation max (%)


Secondary Outcome Measures :
  1. BP [ Time Frame: 7d ]
    Blood pressure


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recent ambulatory daytime systolic BP average between 120 - 155 mmHg or diastolic BP between 80-95 mmHg
  2. Age 18 years and older.
  3. Ability to speak English

Exclusion Criteria:

  1. Any antihypertensive medication use (ACE inhibitors, ARB, beta-blockers, calcium channel blockers, diuretics, alpha agonists or antagonists, nitrates, direct vasodilators such as hydralazine, aldosterone antagonists, direct renin inhibitors, endothelin antagonists)
  2. Current tobacco use.
  3. Diagnosed with diabetes, known coronary artery disease, severe aortic stenosis, idiopathic hypertrophic subaortic stenosis (IHSS), or upper extremity vascular obstruction.
  4. Pregnancy or breast feeding.
  5. Using estrogen-containing birth control methods.
  6. Unwillingness to forgo vitamins C and E, fish oil, niacin, arginine, OTC decongestants, and NSAIDs such as advil, motrin, and nuprin during the study period.
  7. Unwillingness to forgo use of phosphodiesterase inhibitors (sildenafil - 36 hours, vardenafil - 36 hours, tadalafil - 96 hours) prior to study visits.
  8. Unwillingness to refrain from vigorous exercise on the morning of study visits.
  9. Women with childbearing potential who do not agree to practice effective birth control (condom, diaphragm, cervical cap, copper IUD, abstinence).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01331486


Locations
United States, North Carolina
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Gary N Asher, MD, MPH UNC
More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01331486     History of Changes
Other Study ID Numbers: 09-2279
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: December 2011

Keywords provided by University of North Carolina, Chapel Hill:
Prehypertension
Mild hypertension
Flow mediated dilation
Hawthorn

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents