Understanding Pine Bark Extract as an Alternative Treatment (UPBEAT) Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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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):

1. The efficacy of Flavangenol in lowering blood pressure.
2. The efficacy of Flavangenol in improving glycemic control and plasma lipoprotein profile.
3. Changes in body weight, antioxidative capacity, anti-inflammatory markers, blood coagulation factors, and liver function tests in response to Flavangenol.
4. The safety of Flavangenol, as confirmation of past studies.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo delivered as four tablets matching the active product once daily orally.

Group Type PLACEBO_COMPARATOR

Pine Bark Extract (Flavangenol®)

Intervention Type 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.

Pine Bark Extract

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.

Group Type ACTIVE_COMPARATOR

Pine Bark Extract (Flavangenol®)

Intervention Type 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.

Interventions

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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, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Pycnogenol (differing formulation)

Eligibility Criteria

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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