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

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ClinicalTrials.gov Identifier: NCT00425945
Recruitment Status : Completed
First Posted : January 24, 2007
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Collaborator:
Funded by Toyo Shinyaku Co Ltd
Information provided by (Responsible Party):
Randall Stafford, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Pine Bark Extract (Flavangenol®) Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular Effects of Pine Bark Extract
Study Start Date : October 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo delivered as four tablets matching the active product once daily orally.
 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)
Active Comparator: Pine Bark Extract
Flavangenol 200 mg 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.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  2. LDL [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  3. HDL [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  4. Triglycerides [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  5. LDL Particle Size [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  6. HDL Particle Size [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  7. Lipoprotein A [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)

  8. C-reactive Protein [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  9. Body Mass Index [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  10. Weight [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  11. Fasting Blood Glucose [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  12. Fasting Insulin [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  13. Hemoglobin A1c [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  14. ALT/SGPT [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  15. AST/SGOT [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425945


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Funded by Toyo Shinyaku Co Ltd
Investigators
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Principal Investigator: Randall S. Stafford MD, PhD Stanford University
More Information
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Publications of Results:

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Responsible Party: Randall Stafford, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00425945     History of Changes
Other Study ID Numbers: 37698
First Posted: January 24, 2007    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors