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

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
Sponsor:
Collaborator:
Funded by Toyo Shinyaku Co Ltd
Information provided by (Responsible Party):
Randall Stafford, Stanford University

Tracking Information
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
 (submitted: February 19, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
Blood pressure (primary outcome)
Change History Complete list of historical versions of study NCT00425945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2014)
  • Total Cholesterol [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • LDL [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • HDL [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Triglycerides [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • LDL Particle Size [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • HDL Particle Size [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • 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)
  • C-reactive Protein [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Body Mass Index [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Weight [ Time Frame: 3 months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Fasting Blood Glucose [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Fasting Insulin [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • Hemoglobin A1c [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • ALT/SGPT [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
  • AST/SGOT [ Time Frame: three months ]
    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
  • Weight and height
  • Waist circumference
  • Fasting blood glucose
  • Hemoglobin A1c
  • Fasting Insulin
  • Lipid panel w/ calculated LDL
  • LDL particle subclass analysis
  • Lipoprotein A
  • C-reactive Protein
  • ALT/SGPT
  • AST/SGOT
  • 3-day food record
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):

  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 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
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)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo delivered as four tablets matching the active product once daily orally.
    Intervention: Drug: Pine Bark Extract (Flavangenol®)
  • 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.
    Intervention: Drug: Pine Bark Extract (Flavangenol®)
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2007)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Randall S. Stafford MD, PhD Stanford University
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