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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490720
• Other study ID #: 201911003RSC
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: TCI Co., Ltd.
• Contact: Shyr-Chyr Chen
• Phone: (02) 23123456
• Email: scchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.

2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.

3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.

4. 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:

1. Pregnant women.

2. 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).

3. No person has undergone major surgery.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Placebo
consume 1 sachet per day for 2 months
• Buckwheat husk extract
consume 1 sachet per day for 2 months

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)	Blood pressure will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Secondary	Change from baseline in Body Mass Index (BMI)	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	Days 1, 28, and 56
Secondary	Change from baseline in waist-hip ratio	Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Secondary	Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)	Blood lipid will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Secondary	Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)	Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56