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

Not Applicable

Completed

Conditions: Hypertension

Interventions: Drug: Pine Bark Extract (Flavangenol®)

Registration Number: NCT00425945

Lead Sponsor: Stanford University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Pine Bark Extract (Flavangenol®)	Placebo delivered as four tablets matching the active product once daily orally.
Pine Bark Extract	Pine Bark Extract (Flavangenol®)	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.

Primary Outcome Measures

Name	Time	Method
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.	three months	Mean at Week 12 observation minus mean at Baseline observation.

Secondary Outcome Measures

Name	Time	Method
Fasting Insulin	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Hemoglobin A1c	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
ALT/SGPT	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
AST/SGOT	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Fasting Blood Glucose	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Triglycerides	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
LDL Particle Size	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
HDL Particle Size	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Lipoprotein A	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	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Body Mass Index	three months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Weight	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Total Cholesterol	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
LDL	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
HDL	3 months	Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).