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NCT Number: NCT04490720

The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

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Key information

Conditions

Cardiovascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 114, Taiwan

Location status: Recruiting

Location contact

chi fu chiang, Ph.D

CONTACT

[email protected]

About this study

This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
  • The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
  • Those who are not pregnant and are willing to cooperate with contraception during the trial period.
  • No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).

Exclusion criteria

  • Pregnant women.
  • People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
  • No person has undergone major surgery.

Treatment and study plan

Placebo

Dietary Supplement

consume 1 sachet per day for 2 months

Buckwheat husk extract

Dietary Supplement

consume 1 sachet per day for 2 months

Primary outcomes

  1. Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)

    Time frame: Days 1, 28, and 56

    Blood pressure will be measured at the beginning, 4-week, and 8-week time points.

Secondary outcomes

  1. Change from baseline in Body Mass Index (BMI)

    Time frame: Days 1, 28, and 56

    Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points.

    P.S. weight in kilograms, height in meters

  2. Change from baseline in waist-hip ratio

    Time frame: Days 1, 28, and 56

    Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.

  3. Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)

    Time frame: Days 1, 28, and 56

    Blood lipid will be measured at the beginning, 4-week, and 8-week time points.

  4. Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)

    Time frame: Days 1, 28, and 56

    Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.

Study contacts

Contact information is provided by the study sponsor or research team.

Shyr-Chyr Chen

CONTACT

[email protected]

(02) 23123456

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 29, 2020
Registry last updated
Jan 9, 2025

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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