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Completed

NCT Number: NCT00425945

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

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pycnogenol (differing formulation)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total Cholesterol

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  2. LDL

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  3. HDL

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  4. Triglycerides

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  5. LDL Particle Size

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  6. HDL Particle Size

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  7. Lipoprotein A

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up). Calculated as (Pinebark_Followup - Pinebark_Baseline) - (Placebo_Follow-up - Placebo_Baseline)

  8. C-reactive Protein

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  9. Body Mass Index

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  10. Weight

    Time frame: 3 months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  11. Fasting Blood Glucose

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  12. Fasting Insulin

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  13. Hemoglobin A1c

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  14. ALT/SGPT

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

  15. AST/SGOT

    Time frame: three months

    Net change in secondary outcomes from Baseline to 12 Weeks (Follow-up).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Funded by Toyo Shinyaku Co Ltd

Registry information

Official study title

Cardiovascular Effects of Pine Bark Extract

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2007
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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