A clinical trial on the functionality and safety of C. lacerata mycelium cultures
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007722
- Lead Sponsor
- Fugenbio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
1. Men between the ages of 20 and under 75 and non-lactating women with no possibility of pregnancy, except for the illiterate.
2. Subjects with a fasting blood sugar of 100 mg/dL or more and less than 140 mg/dL and HbA1c 7.0% or less, not taking diabetes medication
3. Subjects with a fasting blood sugar of less than 110 mg/dL or HbA1c 6.5% 7.0%
4. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this human application test
1. Subjects with adverse reactions such as allergies when taking medicines or health functional foods
2. Subjects with hypersensitivity to or a history of mushrooms
3. Gastrointestinal disorders that may affect the absorption of test products for human application
(Example: Crohn's disease) or gastrointestinal surgery (however, simple appendectomy or
Those with a history of hernia surgery)
4. Those who show the following results in a diagnostic medical test - AST, ALT > 2 times the upper limit of the normal range - Other significant diagnostic test findings
5. Those with the following clinically significant diseases
Diabetics taking blood sugar lowering drugs or insulin, uncontrolled
Hypertensive patients (140/90 or higher), blood LDL-cholesterol 160 or higher
factor, thyroid dysfunction patients, depression, schizophrenia, alcoholism
Patients with mental disorders such as heart disease, drug addiction, heart failure, angina pectoris, myocardial infarction, etc.
Cardiovascular disease, acute and chronic liver disease (chronic type B, chronic type C)
Hepatitis, various liver cirrhosis, liver cancer, etc.)
6. Obesity drugs, antidepressants, contraceptives, oral steroids within the last 1 month
Lloyd, female hormones, thyroid hormones, etc. have been taken or tested
Drugs that affect the absorption, metabolism, or excretion of food or to reduce blood sugar
Subjects with experience taking drugs that may affect
7. Pregnant and lactating women
8. Those who participated in other human application tests within 1 month before the first intake date
9. In the opinion of the person in charge of testing for human application, it is necessary to follow the
Subjects judged to be unsuitable or otherwise judged to be unsuitable by the physician.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in fasting blood sugar
- Secondary Outcome Measures
Name Time Method changes in blood sugar after eating, changes in glycated hemoglobin (HbA1c) levels, changes in insulin levels, changes in C-peptide levels, changes in blood fat composition