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

Stanford University

Status: Completed

Conditions: Hypertension

Treatments: Drug: Pine Bark Extract (Flavangenol®)

Study type: Interventional

Funder types: Other

Identifiers

NCT00425945

37698

Details and patient eligibility

About

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.

Full 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):

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• DBP > 95 mmHg
• LDL > 170 mg/dL
• TG > 300 mg/dL
• FBG > 110 mg/dL

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

130 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Pine Bark Extract (Flavangenol®)

Pine Bark Extract

Active Comparator group

Description:

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.

Treatment:

Drug: Pine Bark Extract (Flavangenol®)