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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Buckwheat husk extract

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shyr-Chyr Chen; Phone Number: (02) 23123456; Email: scchen@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • National Taiwan University Hospital
    • Contact: chi fu chiang, Ph.D; Email: Jimmy.Chiang@tci-bio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; consume 1 sachet per day for 2 months	Dietary supplement: Placebo; consume 1 sachet per day for 2 months
Experimental: Buckwheat husk extract; consume 1 sachet per day for 2 months	Dietary supplement: Buckwheat husk extract; consume 1 sachet per day for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Mao-Hsin Lin, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 201911003RSC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No