NCT04490720RecruitingNot Applicable
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- TCI Co., Ltd.
- 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
Study Sites (2)
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