HypertensionNCT00425945
Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study
A study testing Pine Bark Extract (Flavangenol®) in people with Hypertension, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Pine Bark Extract (Flavangenol®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- DBP > 95 mmHg
- LDL > 170 mg/dL
- TG > 300 mg/dL
- FBG > 110 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Cardiovascular Effects of Pine Bark Extract
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.
Read the 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):
- The efficacy of Flavangenol in lowering blood pressure.
- The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
- Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
- The safety of Flavangenol, as confirmation of past studies.
- Conditions
- Hypertension
- Being tested
- Pine Bark Extract (Flavangenol®)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pine Bark Extract (Flavangenol®)Drug
Also called Pycnogenol (differing formulation)
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo delivered as four tablets matching the active product once daily orally. Receives: Drug: Pine Bark Extract (Flavangenol®) |
| 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. Receives: Drug: Pine Bark Extract (Flavangenol®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
Mean at Week 12 observation minus mean at Baseline observation.
Measured: three months
Secondary outcomes (15)
Total Cholesterol
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 3 months
LDL
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 3 months
HDL
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 3 months
Triglycerides
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
LDL Particle Size
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 3 months
HDL Particle Size
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 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)
Measured: three months
C-reactive Protein
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
Body Mass Index
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
Weight
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: 3 months
Fasting Blood Glucose
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
Fasting Insulin
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
Hemoglobin A1c
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
ALT/SGPT
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
AST/SGOT
Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Funded by Toyo Shinyaku Co Ltd
- Responsible party
- Principal investigator, Randall Stafford, Stanford University
- Investigators
- Randall S. Stafford MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425945
- Sponsor's protocol ID
- 37698
- Status last verified
- Feb 2014
- First submitted
- 23 Jan 2007
- Last updated
- 2 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 20876405
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Pine Bark Extract
- ClinicalTrials.gov ID
- NCT00425945
- Acronym / sponsor ID
- 37698
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Funded by Toyo Shinyaku Co Ltd
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- The efficacy of Flavangenol in lowering blood pressure.
- The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
- Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
- The safety of Flavangenol, as confirmation of past studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Pine Bark Extract (Flavangenol®)Placebo delivered as four tablets matching the active product once daily orally. |
| Pine Bark Extract | Active comparator | Drug: Pine Bark Extract (Flavangenol®)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (4 listed)
- DBP > 95 mmHg
- LDL > 170 mg/dL
- TG > 300 mg/dL
- FBG > 110 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pine Bark Extract (Flavangenol®)Also: Pycnogenol (differing formulation)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. | Drug | Pine Bark Extract, Placebo |
Primary outcome
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12.
Time frame: three months
Mean at Week 12 observation minus mean at Baseline observation.
15 secondary outcomes
Total Cholesterol
Time frame: 3 months
LDL
Time frame: 3 months
HDL
Time frame: 3 months
Triglycerides
Time frame: three months
LDL Particle Size
Time frame: 3 months
HDL Particle Size
Time frame: 3 months
Lipoprotein A
Time frame: three months
C-reactive Protein
Time frame: three months
Body Mass Index
Time frame: three months
Weight
Time frame: 3 months
Fasting Blood Glucose
Time frame: three months
Fasting Insulin
Time frame: three months
Hemoglobin A1c
Time frame: three months
ALT/SGPT
Time frame: three months
AST/SGOT
Time frame: three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20876405Drieling 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall S. Stafford MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pine Bark Extract (Flavangenol®) in people with Hypertension, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined Change in Systolic and Diastolic Blood Pressures From Baseline to Week 12. (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00425945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2014.