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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:
Collaborator:
Funded by Toyo Shinyaku Co Ltd
Information provided by (Responsible Party):
Randall Stafford, Stanford University

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
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
Hide Arm/Group Description

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
Arm/Group Title Pine Bark Extract Placebo Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[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%
1.Primary Outcome
Title Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
Hide Description Mean at Week 12 observation minus mean at Baseline observation.
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.
Arm/Group Title Pine Bark Extract Placebo
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 64 66
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
-1.0
(-4.2 to 2.1)
-1.9
(-5.5 to 1.7)
2.Secondary Outcome
Title Total Cholesterol
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.4  (17.5) -2.0  (23.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-0.1 to 14.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title LDL
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
3.3  (16.6) -1.1  (19.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
-2.1 to 10.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title HDL
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.9  (6.0) -1.3  (5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-1.7 to 2.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Triglycerides
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
17.2  (50.6) -1.0  (63.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
-2.3 to 38.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title LDL Particle Size
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: nm
31.4  (200.2) 28.5  (248.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.1 to 0.3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title HDL Particle Size
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: nm
1.0  (3.1) 0.0  (4.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.0 to 0.1
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Lipoprotein A
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 59 60
Mean (Standard Deviation)
Unit of Measure: nmol/L
-1.3  (10.3) 1.8  (10.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.8 to 0.5
Estimation Comments [Not Specified]
9.Secondary Outcome
Title C-reactive Protein
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 63
Mean (Standard Deviation)
Unit of Measure: nmol/L
-0.2  (2.56) 0.3  (2.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.5 to 0.5
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Body Mass Index
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.1  (0.4) -0.1  (0.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
0.0 to 0.4
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Weight
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: lb
0.6  (3.1) -0.6  (3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.1 to 2.4
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Fasting Blood Glucose
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 59 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.0  (9.8) 0.1  (8.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-4.4 to 2.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Fasting Insulin
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.2  (4.2) -0.6  (5.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-0.9 to 2.5
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Hemoglobin A1c
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed on an intent-to-treat basis, with the last observation collected carried forward for participants with missing data at follow-up.
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 58 62
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.0  (0.2) -0.0  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.1 to 0.1
Estimation Comments [Not Specified]
15.Secondary Outcome
Title ALT/SGPT
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: u/L
0.8  (15.11) -3.0  (15.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-1.6 to 9.3
Estimation Comments [Not Specified]
16.Secondary Outcome
Title AST/SGOT
Hide Description Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Time Frame three months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pine Bark Extract (Net Change) Placebo (Net Change)
Hide Arm/Group Description:

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.
Overall Number of Participants Analyzed 60 62
Mean (Standard Deviation)
Unit of Measure: u/L
0.2  (4.9) 1.4  (6.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pine Bark Extract (Net Change), Placebo (Net Change)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.4 to 0.8
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pine Bark Extract Placebo
Hide Arm/Group Description

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.
All-Cause Mortality
Pine Bark Extract Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Pine Bark Extract Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/64 (1.56%)      2/66 (3.03%)    
Musculoskeletal and connective tissue disorders     
Emergency Department  [1]  0/64 (0.00%)  0 2/66 (3.03%)  2
Surgical and medical procedures     
Hospitalized  [2]  1/64 (1.56%)  1 0/66 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Dislocated toe; Received tetanus booster after stepping on a nail
[2]
Hip Surgery
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pine Bark Extract Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/64 (37.50%)      29/66 (43.94%)    
Gastrointestinal disorders     
Gastrointestinal Discomfort (week 3)   12/64 (18.75%)  12 9/66 (13.64%)  9
Gastrointestinal Discomfort (week 6)   8/64 (12.50%)  8 3/66 (4.55%)  3
Nause (week 12)   6/64 (9.38%)  6 1/66 (1.52%)  1
General disorders     
Sleepiness (week 12)   5/64 (7.81%)  5 12/66 (18.18%)  12
Increased Perspiration (week 6)   5/64 (7.81%)  5 1/66 (1.52%)  1
Other (week 6)   7/64 (10.94%)  7 2/66 (3.03%)  2
Nervous system disorders     
Dizziness (week 3)   1/64 (1.56%)  1 5/66 (7.58%)  5
Dizziness (week 12)   3/64 (4.69%)  3 7/66 (10.61%)  7
Headache (week 12)   8/64 (12.50%)  8 13/66 (19.70%)  13
Insomnia (week 6)   4/64 (6.25%)  4 11/66 (16.67%)  11
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Randall Stafford
Organization: Stanford University School of Medicine
Phone: 650-724-2400
EMail: rstafford@stanford.edu
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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