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.

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.

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