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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Buckwheat husk extract

• Registration Number: NCT04490720
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Study Start: 2021-11-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	consume 1 sachet per day for 2 months
Buckwheat husk extract	Buckwheat husk extract	consume 1 sachet per day for 2 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)	Days 1, 28, and 56	Blood pressure will be measured at the beginning, 4-week, and 8-week time points.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan