Clinical trial NCT00425945: Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
Official title: Cardiovascular Effects of Pine Bark Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Funded by Toyo Shinyaku Co Ltd
First posted: 2007-01-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
timeFrame: three months
Secondary outcomes:
measure: Total Cholesterol
timeFrame: 3 months
measure: LDL
timeFrame: 3 months
measure: HDL
timeFrame: 3 months
measure: Triglycerides
timeFrame: three months
measure: LDL Particle Size
timeFrame: 3 months
measure: HDL Particle Size
timeFrame: 3 months
measure: Lipoprotein A
timeFrame: three months
measure: C-reactive Protein
timeFrame: three months
measure: Body Mass Index
timeFrame: three months
measure: Weight
timeFrame: 3 months
measure: Fasting Blood Glucose
timeFrame: three months
measure: Fasting Insulin
timeFrame: three months
measure: Hemoglobin A1c
timeFrame: three months
measure: ALT/SGPT
timeFrame: three months
measure: AST/SGOT
timeFrame: three months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Randall S. Stafford MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Drieling RL, Gardner CD, Ma J, Ahn DK, Stafford RS. No beneficial effects of pine bark extract on cardiovascular disease risk factors. Arch Intern Med. 2010 Sep 27;170(17):1541-7. doi: 10.1001/archinternmed.2010.310.