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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Pine Bark Extract (Flavangenol®) | Not Applicable |
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):
- The efficacy of Flavangenol in lowering blood pressure.
- The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
- Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
- The safety of Flavangenol, as confirmation of past studies.
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 |

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) |
- 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.
- 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).

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Randall S. Stafford MD, PhD | Stanford University |
Responsible Party: | Randall Stafford, Professor of Medicine, Stanford University |
ClinicalTrials.gov Identifier: | NCT00425945 |
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 |
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 |