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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
130
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.
Stanford University School of Medicine
Stanford, California, United States
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
Mean at Week 12 observation minus mean at Baseline observation.
Time frame: three months
Total Cholesterol
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 3 months
LDL
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 3 months
HDL
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 3 months
Triglycerides
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
LDL Particle Size
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 3 months
HDL Particle Size
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 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)
Time frame: three months
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C-reactive Protein
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
Body Mass Index
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
Weight
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: 3 months
Fasting Blood Glucose
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
Fasting Insulin
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
Hemoglobin A1c
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
ALT/SGPT
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months
AST/SGOT
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time frame: three months