Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331486
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : February 7, 2013
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

April 6, 2011
April 8, 2011
February 7, 2013
May 2010
June 2011   (Final data collection date for primary outcome measure)
FMD Max [ Time Frame: 7d ]
Brachial artery flow mediated dilation max (%)
Same as current
Complete list of historical versions of study NCT01331486 on Archive Site
BP [ Time Frame: 7d ]
Blood pressure
Same as current
Not Provided
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Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract
Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Prehypertension
  • Mild Hypertension
  • Dietary Supplement: Hawthorn
    Hawthorn standardized extract liquid capsule
    Other Name: Gaia Hawthorn Supreme
  • Dietary Supplement: Placebo capsule
    Matched placebo liquid capsule
  • Placebo Comparator: Placebo
    Placebo capsule
    Intervention: Dietary Supplement: Placebo capsule
  • Active Comparator: Low dose
    Intervention: Dietary Supplement: Hawthorn
  • Active Comparator: Mid dose
    Intervention: Dietary Supplement: Hawthorn
  • Active Comparator: High dose
    Intervention: Dietary Supplement: Hawthorn
Asher GN, Viera AJ, Weaver MA, Dominik R, Caughey M, Hinderliter AL. Effect of hawthorn standardized extract on flow mediated dilation in prehypertensive and mildly hypertensive adults: a randomized, controlled cross-over trial. BMC Complement Altern Med. 2012 Mar 29;12:26. doi: 10.1186/1472-6882-12-26.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2011
June 2011   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Gary N Asher, MD, MPH UNC
University of North Carolina, Chapel Hill
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP