The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTCI Co., Ltd.
About this trial
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Dietary supplementconsume 1 sachet per day for 2 months
Buckwheat husk extract
Dietary supplementconsume 1 sachet per day for 2 months
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Buckwheat husk extractExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Days 1, 28, and 56Secondary outcomes
1
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
Time frame
Days 1, 28, and 562
Change from baseline in waist-hip ratio
Waist-hip ratio will be measured at the beginning, 4-week, and 8-week time points.
Time frame
Days 1, 28, and 563
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.
Time frame
Days 1, 28, and 564
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.
Time frame
Days 1, 28, and 56Sponsors and contacts
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Source ClinicalTrials.gov