Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00425945 |
Recruitment Status :
Completed
First Posted : January 24, 2007
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
|
Sponsor:
Stanford University
Collaborator:
Funded by Toyo Shinyaku Co Ltd
Information provided by (Responsible Party):
Randall Stafford, Stanford University
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
Condition |
Hypertension |
Intervention |
Drug: Pine Bark Extract (Flavangenol®) |
Enrollment | 130 |
Participant Flow
Recruitment Details | Participants were recruited from the local community through the use of radio and print advertisements between January 31, 2007 and May 31, 2008. |
Pre-assignment Details | Prior to randomization, participants were scheduled to complete two baseline visits three to seven days apart at the Stanford GCRC. Only those who successfully completed both baseline visits were randomized into the study. |
Arm/Group Title | Pine Bark Extract | Placebo |
---|---|---|
![]() |
200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol®) : 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, 50 mg per tablet, taken once per day orally for 12 weeks. |
Placebo delivered as four tablets matching the active product; four tablets taken daily orally. |
Period Title: Overall Study | ||
Started | 64 | 66 |
Completed | 60 | 61 |
Not Completed | 4 | 5 |
Reason Not Completed | ||
Concern about Supplement | 2 | 0 |
Inconvenience | 0 | 2 |
Lost to Follow-up | 0 | 2 |
Began hypertension medication | 1 | 0 |
Began cancer treatments | 1 | 0 |
Moved from area | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Pine Bark Extract | Placebo | Total | |
---|---|---|---|---|
![]() |
200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks. | Placebo delivered as four tablets matching the active product; four tablets taken daily orally. | Total of all reporting groups | |
Overall Number of Baseline Participants | 64 | 66 | 130 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 64 participants | 66 participants | 130 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
51 79.7%
|
55 83.3%
|
106 81.5%
|
|
>=65 years |
13 20.3%
|
11 16.7%
|
24 18.5%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 64 participants | 66 participants | 130 participants | |
56.9 (9.8) | 53.9 (12.0) | 55.4 (11.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 64 participants | 66 participants | 130 participants | |
Female |
25 39.1%
|
23 34.8%
|
48 36.9%
|
|
Male |
39 60.9%
|
43 65.2%
|
82 63.1%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Randall Stafford |
Organization: | Stanford University School of Medicine |
Phone: | 650-724-2400 |
EMail: | rstafford@stanford.edu |
Publications of Results:
Responsible Party: | Randall Stafford, Stanford University |
ClinicalTrials.gov Identifier: | NCT00425945 |
Other Study ID Numbers: |
37698 |
First Submitted: | January 23, 2007 |
First Posted: | January 24, 2007 |
Results First Submitted: | March 29, 2013 |
Results First Posted: | April 2, 2014 |
Last Update Posted: | April 2, 2014 |