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CompletedNCT01331486Updated Feb 7, 2013

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

A Phase 1 interventional study of Hawthorn and Placebo capsule in Prehypertension and Mild Hypertension, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-07.

Sponsored by University of North Carolina, Chapel Hill · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Prehypertension
  • Mild Hypertension

Keywords

  • Prehypertension
  • Mild hypertension
  • Flow mediated dilation
  • Hawthorn
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 24 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo capsule

    Dietary Supplement: Placebo capsule

  • Active comparator
    Low dose

    Dietary Supplement: Hawthorn

  • Active comparator
    Mid dose

    Dietary Supplement: Hawthorn

  • Active comparator
    High dose

    Dietary Supplement: Hawthorn

Interventions

  • Dietary supplementHawthorn

    Hawthorn standardized extract liquid capsule

    Also known as: Gaia Hawthorn Supreme

  • Dietary supplementPlacebo capsule

    Matched placebo liquid capsule

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What researchers measure

Primary outcomes

  1. FMD Max

    Brachial artery flow mediated dilation max (%)

    Time frame: 7d

Secondary outcomes

  1. BP

    Blood pressure

    Time frame: 7d

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Study locations

1 site
  • UNC Department of Family Medicine
    Chapel Hill, North Carolina 27599, United States
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References and documents

Publications

  • 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. PubMed 22458601 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01331486
Lead sponsor
University of North Carolina, Chapel Hill
Responsible party
Sponsor
First posted
Apr 8, 2011
Start date
May 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Feb 7, 2013

Study contacts

Gary N Asher, MD, MPH
principal investigator · UNC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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