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

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

Tracking Information

• First Submitted Date: January 23, 2007
• First Posted Date: January 24, 2007
• Results First Submitted Date: March 29, 2013
• Results First Posted Date: April 2, 2014
• Last Update Posted Date: April 2, 2014
• Study Start Date: October 2006
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Hypertension

Intervention

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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2007): 130
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00425945
• Other Study ID Numbers: 37698
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Randall Stafford, Stanford University
• Study Sponsor: Stanford University
• Collaborators: Funded by Toyo Shinyaku Co Ltd

Investigators

• Principal Investigator: Randall S. Stafford MD, PhD; Stanford University

• PRS Account: Stanford University
• Verification Date: February 2014