Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
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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. |
ClinicalTrials.gov Identifier: NCT00425945 |
Recruitment Status :
Completed
First Posted : January 24, 2007
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | January 23, 2007 | |||
First Posted Date ICMJE | January 24, 2007 | |||
Results First Submitted Date ICMJE | March 29, 2013 | |||
Results First Posted Date ICMJE | April 2, 2014 | |||
Last Update Posted Date | April 2, 2014 | |||
Study Start Date ICMJE | October 2006 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. [ Time Frame: three months ] Mean at Week 12 observation minus mean at Baseline observation.
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Original Primary Outcome Measures ICMJE |
Blood pressure (primary outcome) | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study | |||
Official Title ICMJE | Cardiovascular Effects of Pine Bark Extract | |||
Brief Summary | The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile. | |||
Detailed Description | Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, among 130 study participants. These participants will be individuals at mildly or moderately elevated risk of cardiovascular disease (CVD) because of having prehypertension, excess body weight, and insulin insensitivity. We aim to determine (in order of priority):
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE | Drug: Pine Bark Extract (Flavangenol®)
Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks. Other Name: Pycnogenol (differing formulation)
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Study Arms ICMJE |
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Publications * | Drieling RL, Gardner CD, Ma J, Ahn DK, Stafford RS. No beneficial effects of pine bark extract on cardiovascular disease risk factors. Arch Intern Med. 2010 Sep 27;170(17):1541-7. doi: 10.1001/archinternmed.2010.310. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
130 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00425945 | |||
Other Study ID Numbers ICMJE | 37698 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Randall Stafford, Stanford University | |||
Study Sponsor ICMJE | Stanford University | |||
Collaborators ICMJE | Funded by Toyo Shinyaku Co Ltd | |||
Investigators ICMJE |
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PRS Account | Stanford University | |||
Verification Date | February 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |