Recruiting NCT04490720
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Buckwheat husk extract.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement Placebo
consume 1 sachet per day for 2 months - Dietary supplement Buckwheat husk extract
consume 1 sachet per day for 2 months
Primary outcome measures
- Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure) [Time frame: Days 1, 28, and 56]
Secondary outcome measures (4)
- Change from baseline in Body Mass Index (BMI) [Time frame: Days 1, 28, and 56]
- Change from baseline in waist-hip ratio [Time frame: Days 1, 28, and 56]
- Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C) [Time frame: Days 1, 28, and 56]
- Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide) [Time frame: Days 1, 28, and 56]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT04490720 · 201911003RSC