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Clinical Trials/NCT04490720
NCT04490720RecruitingNot Applicable

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

TCI Co., Ltd.2 sites in 1 country60 target enrollmentStarted: November 24, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
2
Primary Endpoint
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

  • Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)(Days 1, 28, and 56)
  • Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)(Days 1, 28, and 56)
  • Change from baseline in Body Mass Index (BMI)(Days 1, 28, and 56)
  • Change from baseline in waist-hip ratio(Days 1, 28, and 56)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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