Cardiovascular Diseases
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
consume 1 sachet per day for 2 months
DIETARY_SUPPLEMENTBuckwheat husk extract
consume 1 sachet per day for 2 months
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Taiwan
Contacts
Primary ContactShyr-Chyr Chen
Outcome results
None listed