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

Cardiovascular Effects of Pine Bark Extract

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Pine Bark Extract (Flavangenol®)

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
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Pycnogenol (differing formulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.	Mean at Week 12 observation minus mean at Baseline observation.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cholesterol	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
LDL	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
HDL	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
Triglycerides	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
LDL Particle Size	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
HDL Particle Size	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
Lipoprotein A	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)	three months
C-reactive Protein	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
Body Mass Index	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
Weight	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	3 months
Fasting Blood Glucose	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
Fasting Insulin	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
Hemoglobin A1c	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
ALT/SGPT	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months
AST/SGOT	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).	three months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Funded by Toyo Shinyaku Co Ltd
• Investigators: Principal Investigator: Randall S. Stafford MD, PhD, Stanford University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 23, 2007
• First Submitted That Met QC Criteria: January 23, 2007
• First Posted (Estimate): January 24, 2007

Study Record Updates

• Last Update Posted (Estimate): April 2, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Antioxidants; Pycnogenols
• Other Study ID Numbers: 37698