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

This study has been completed.
Sponsor:
Collaborator:
Funded by Toyo Shinyaku Co Ltd
Information provided by (Responsible Party):
Randall Stafford, Stanford University
ClinicalTrials.gov Identifier:
NCT00425945
First received: January 23, 2007
Last updated: February 19, 2014
Last verified: February 2014
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:
  • Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. [ Time Frame: three months ] [ Designated as safety issue: No ]
    Mean at Week 12 observation minus mean at Baseline observation.


Secondary Outcome Measures:
  • Total Cholesterol [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • LDL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • HDL [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Triglycerides [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • LDL Particle Size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • HDL Particle Size [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Lipoprotein A [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)

  • C-reactive Protein [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Body Mass Index [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Fasting Blood Glucose [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Fasting Insulin [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • Hemoglobin A1c [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • ALT/SGPT [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  • AST/SGOT [ Time Frame: three months ] [ Designated as safety issue: No ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
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 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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Funded by Toyo Shinyaku Co Ltd
Investigators
Principal Investigator: Randall S. Stafford MD, PhD Stanford University
  More Information

Publications:

Responsible Party: Randall Stafford, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00425945     History of Changes
Other Study ID Numbers: 37698
Study First Received: January 23, 2007
Results First Received: March 29, 2013
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 27, 2015