Randall Stafford
Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Pine Bark Extract (Flavangenol?)
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key 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
Key Exclusion Criteria:
-DBP > 95 mmHg
-LDL > 170 mg/dL
-TG > 300 mg/dL
-FBG > 110 mg/dL
Additional Study Details
Official Title:
Cardiovascular Effects of Pine Bark ExtractAnticipated start date:
10/1/2006Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- Blood pressure (primary outcome)
Secondary Outcomes:
- Weight and height
- Waist circumference
- Fasting blood glucose
- Hemoglobin A1c
- Fasting insulin
- Lipid panel w/ calculated LDL
- LDL particle subclass analysis
- Lipoprotein A
- C-reactive protein
- ALT/SGPT
- AST/SGOT
- 3-day food record
Total Number to be Enrolled:
0Total Number to be Enrolled at Stanford:
130More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
2/13/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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