None listed
Conditions
Interventions
Others(health functional food) : The test food(MCT101C) or the control food(Placebo) is to be taken orally twice a day, 3 capsules per dose.
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with type 2 diabetes aged 19 years or older and younger than 65 years. 2) Individuals with an HbA1c level of 7.0% or higher and less than 9.0% measured at Visit 1. 3) Individuals who have been taking the same medication and dosage of diabetes medication along with diet and exercise therapy for more than 3 months (90 days) as of Visit 1 and can maintain the medication and dosage without change during the study period. 4) Individuals who agreed to participate in this human application study and completed a written informed consent form before the start of the human application study.
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver/biliary, renal and urinary, nervous, psychiatric, infectious, or malignant tumors (except for malignant tumors, which must have been cured for at least 5 years). 2) Individuals with congenital glycolytic enzyme deficiency. 3) Individuals with gastrointestinal disorders that interfere with the intake of food products for human clinical trials. 4) Individuals with type 1 diabetes and those with severe complications of diabetes (e.g., diabetic ketoacidosis, hyperglycemic osmolality, renal failure). 5) Individuals with a history of bariatric surgery (e.g., sleeve gastrectomy, adjustable gastric banding, Roux-en-Y gastric bypass). 6) Individuals who have undergone gastrointestinal procedures/surgeries (gastroenterectomy, endoscopic variceal ligation, etc.) within 1 year of Visit 1 (However, those who have undergone procedures such as appendectomy, hernia surgery, endoscopic colon polypectomy, etc. and the investigator determines that such procedures will not affect participation in the study may participate) 7) Alpha-glucosidase Inhibitors, individuals using insulin 8) Individuals who have used the following medications and foods within 3 months (90 days) prior to Visit 1 ? Medications that may affect blood sugar {adrenal cortex hormones (steroids), oral contraceptives (ethinyl estradiol, istriol, etc.), diuretics (hydrochlorthiazide, furosemide, etc.), thyroid hormones, etc.} ? Anti-obesity medications (appetite suppressants, fat absorption inhibitors, GLP-1 analogs, etc.), lipid-lowering agents (statins, ezetimibe, cholestyramine, nicotinic acid, fibrates, omega-3 acids, etc.) {However, participation and concurrent use of statins, ezetimibe, and omega-3 acids are permitted only if the medication and dosage have been administered without change for 3 months (90 days) prior to Visit 1 and the medication and dosage remain unchanged throughout the study period.} 9) Individuals who have taken systemic antibiotics, intestinal drugs, probiotics, prebiotics, or continuous (more than 4 days a week) probiotic products in the two weeks prior to visit 1. 10) Individuals who have taken health functional foods containing histidine, tryptophan, or banaba leaf extract within 1 month (30 days) of Visit 1. 11) Individuals with a BMI of less than 18.5 kg/m2 and greater than 35 kg/m2. 12) Current smokers as of Visit 1. 13) Individuals with a history of alcohol or drug abuse/dependence/addiction, or chronic alcohol consumption* * Consumption equivalent to an average of 40 g or more of alcohol per day (280 g/week) for men and 20 g or more of alcohol per day (140 g/week) for women 14) Individuals with a fasting blood glucose level of 240 mg/dL or higher 15) Individuals with AST (GOT) or ALT (GPT) levels three times or more the upper limit of normal for the testing institution 16) Individuals with a TSH level of 0.1 µIU/mL or lower or 10 µIU/mL or higher 17) Individuals with an eGFR of less than 60 mL/min/1.73 m2 18) Patients with uncontrolled hypertension (systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg, measured after 10 minutes of rest) 19) Pregnant or lactating women or individuals planning to become pregnant during this human application study 20) Individuals who have participated in another interventional clinical trial (including human application trials) within 3 months (90 days) of Visit 1 or who pl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c(Hemoglobin A1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting Blood Sugar;Insulin;Homeostasis Model Assessment of Insulin Resistance;Glycated albumin;Blood lipids(Triglyceride, Total Cholesterol, HDL-cholesterol, LDL-cholesterol);high-sensitivity C-reactive protein | — |
Countries
Korea, Republic of
Contacts
Public ContactDohoon Kim
Korea University Ansan Hospital
Outcome results
None listed