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Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00425945
First received: January 23, 2007
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Drug: Pine Bark Extract (Flavangenol®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Pine Bark Extract

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AST/SGOT [ Time Frame: three months ] [ Designated as safety issue: No ]
  • ALT/SGPT [ Time Frame: three months ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Lipoprotein A [ Time Frame: three months ] [ Designated as safety issue: No ]
  • LDL particle subclass [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Lipid panel w/ calculated LDL [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Fasting blood glucose Outcome Time Frame: [ Time Frame: three months ] [ Designated as safety issue: No ]
  • Hemoglobin A1c [ Time Frame: three months ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo delivered as two tablets matching the active product once daily orally.
 Drug: Pine Bark Extract (Flavangenol®)

Flavangenol 80 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.

Dosage delivered as two tablets 40 mg taken once per day orally for 12 weeks.

Other Name: Pycnogenol (differing formulation)
Active Comparator: Pine Bark Extract
Flavangenol 80 mg Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as two tablets 40 mg once per day orally.
 Drug: Pine Bark Extract (Flavangenol®)

Flavangenol 80 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.

Dosage delivered as two tablets 40 mg taken once per day orally for 12 weeks.

Other Name: Pycnogenol (differing formulation)

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):

  1. The efficacy of Flavangenol in lowering blood pressure.
  2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
  3. Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
  4. The safety of Flavangenol, as confirmation of past studies.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Systolic blood pressure between 125 and 159 mmHg and diastolic blood pressure (DBP) < 100 mmHg
  • Body mass index (BMI) 25.0-34.9
  • Triglycerides (TG) < 450 mg/dL
  • Low Density Lipoprotein (LDL) < 200 mg/dL
  • Fasting blood glucose (FBG) < 126 mg/dL

Exclusion Criteria:

  • DBP > 95 mmHg
  • LDL > 170 mg/dL
  • TG > 300 mg/dL
  • FBG > 110 mg/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425945

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Randall S. Stafford MD, PhD Stanford University
  More Information

Publications:

Responsible Party: Randall S. Stafford MD, PhD, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00425945     History of Changes
Other Study ID Numbers: 37698
Study First Received: January 23, 2007
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013