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| Name | Class |
|---|---|
| Funded by Toyo Shinyaku Co Ltd | UNKNOWN |
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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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo delivered as four tablets matching the active product once daily orally. |
|
| Pine Bark Extract | Active Comparator | Flavangenol 200 mg 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pine Bark Extract (Flavangenol®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. | Mean at Week 12 observation minus mean at Baseline observation. | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 3 months |
| LDL | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall S. Stafford MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20876405 | Result | 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. |
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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.
Participants were recruited from the local community through the use of radio and print advertisements between January 31, 2007 and May 31, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pine Bark Extract | 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. |
| FG001 | Placebo | Placebo delivered as four tablets matching the active product; four tablets taken daily orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pine Bark Extract | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. | Mean at Week 12 observation minus mean at Baseline observation. | 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. | Posted | Mean | 95% Confidence Interval | mm Hg | three months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pine Bark Extract | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized | Surgical and medical procedures | Systematic Assessment | Hip Surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Discomfort (week 3) | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Randall Stafford | Stanford University School of Medicine | 650-724-2400 | rstafford@stanford.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C024070 | pycnogenols |
| C504746 | flavangenol |
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|
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| 3 months |
| HDL | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 3 months |
| Triglycerides | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| LDL Particle Size | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 3 months |
| HDL Particle Size | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 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) | three months |
| C-reactive Protein | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| Body Mass Index | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| Weight | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 3 months |
| Fasting Blood Glucose | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| Fasting Insulin | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| Hemoglobin A1c | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| ALT/SGPT | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| AST/SGOT | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | three months |
| Lost to Follow-up |
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| Began hypertension medication |
|
| Began cancer treatments |
|
| Moved from area |
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| BG001 | Placebo | Placebo delivered as four tablets matching the active product; four tablets taken daily orally. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo delivered as four tablets matching the active product; four tablets taken daily orally. |
|
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| Secondary | Total Cholesterol | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | 3 months |
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| Secondary | LDL | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | 3 months |
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| Secondary | HDL | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | 3 months |
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| Secondary | Triglycerides | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | three months |
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| Secondary | LDL Particle Size | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | nm | 3 months |
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| Secondary | HDL Particle Size | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | nm | 3 months |
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| Secondary | 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) | Posted | Mean | Standard Deviation | nmol/L | three months |
|
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| Secondary | C-reactive Protein | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 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. | Posted | Mean | Standard Deviation | nmol/L | three months |
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| Secondary | Body Mass Index | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | kg/m^2 | three months |
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| Secondary | Weight | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | lb | 3 months |
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| Secondary | Fasting Blood Glucose | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | three months |
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| Secondary | Fasting Insulin | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | mg/dL | three months |
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| Secondary | Hemoglobin A1c | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | 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. | Posted | Mean | Standard Deviation | mg/dL | three months |
|
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| Secondary | ALT/SGPT | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | u/L | three months |
|
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| Secondary | AST/SGOT | Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). | Posted | Mean | Standard Deviation | u/L | three months |
|
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|
| 1 |
| 64 |
| 24 |
| 64 |
| EG001 | Placebo | Placebo delivered as four tablets matching the active product; four tablets taken daily orally. | 2 | 66 | 29 | 66 |
| Emergency Department | Musculoskeletal and connective tissue disorders | Systematic Assessment | Dislocated toe; Received tetanus booster after stepping on a nail |
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| Gastrointestinal Discomfort (week 6) | Gastrointestinal disorders | Systematic Assessment |
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| Nause (week 12) | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness (week 3) | Nervous system disorders | Systematic Assessment |
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| Dizziness (week 12) | Nervous system disorders | Systematic Assessment |
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| Headache (week 12) | Nervous system disorders | Systematic Assessment |
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| Sleepiness (week 12) | General disorders | Systematic Assessment |
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| Insomnia (week 6) | Nervous system disorders | Systematic Assessment |
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| Increased Perspiration (week 6) | General disorders | Systematic Assessment |
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| Other (week 6) | General disorders | Systematic Assessment |
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