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

Study Overview
=================
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): 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.

Official Title
-----------------
Cardiovascular Effects of Pine Bark Extract

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Pine Bark Extract (Flavangenol®)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo delivered as four tablets matching the active product once daily orally. | Drug: Pine Bark Extract (Flavangenol®)<br>* 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.<br>* Other names: Pycnogenol (differing formulation);|
| Active Comparator: Pine Bark Extract<br>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®)<br>* 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.<br>* 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 |