Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

NCT ID: NCT01331486

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prehypertension Mild Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Matched placebo liquid capsule

Low dose

Group Type ACTIVE_COMPARATOR

Hawthorn

Intervention Type DIETARY_SUPPLEMENT

Hawthorn standardized extract liquid capsule

Mid dose

Group Type ACTIVE_COMPARATOR

Hawthorn

Intervention Type DIETARY_SUPPLEMENT

Hawthorn standardized extract liquid capsule

High dose

Group Type ACTIVE_COMPARATOR

Hawthorn

Intervention Type DIETARY_SUPPLEMENT

Hawthorn standardized extract liquid capsule

Interventions

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Hawthorn

Hawthorn standardized extract liquid capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

Matched placebo liquid capsule

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Gaia Hawthorn Supreme

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary N Asher, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC

Locations

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UNC Department of Family Medicine

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22458601 (View on PubMed)

Other Identifiers

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09-2279

Identifier Type: -

Identifier Source: org_study_id

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