None listed
Conditions
Interventions
Dietary Supplement : Test food (ICP25): The main ingredient is ice plant extract, taken orally with sufficient water at a dosage of 5 capsules per day for 12 weeks, content of 428.4mg/capsule, dark br
Sponsors
H Plus Yangji Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 19 years or older and under 65 years 2) Individuals with a fasting blood sugar of 100-125 mg/dL or those whose blood sugar is between 140-199 mg/dL after a 2-hour oral glucose tolerance test 3) Individuals who agree to participate in this clinical trial and have signed a written informed consent form before the start of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Individuals currently undergoing treatment for severe diseases of the cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary, renal and urinary, nervous, endocrine, psychiatric, infectious systems, or malignancies. 2. Individuals with cardiovascular diseases such as heart failure, myocardial infarction, stroke, lipid metabolism disorders, or acute/chronic inflammation (However, participation is allowed if the investigator determines that it does not affect the study results). 3. Individuals with a history of type 1 or type 2 diabetes. 4. Individuals who have taken the following drugs or dietary supplements within 3 months prior to Visit 1: ? Drugs that may affect blood glucose levels (e.g., corticosteroids, oral contraceptives such as ethinyl estradiol and estriol, diuretics such as hydrochlorothiazide and furosemide, thyroid hormone medications, etc.) ? Functional foods that may help improve blood glucose (e.g., indigestible maltodextrin, banana leaf extract, *Lacticaseibacillus plantarum* HAC01 probiotics, guar gum/guar gum hydrolysate, immature bitter melon ethanol extract powder, red ginseng, concentrated enzymatic hydrolyzed ginseng extract, etc.) ? Antidiabetic agents (e.g., glucose-lowering agents such as GLP-1 agonists, DPP-4 inhibitors, SGLT-2 inhibitors, insulin, etc.) ? Anti-obesity drugs (e.g., appetite suppressants, fat absorption inhibitors, GLP-1 analogs), and lipid-lowering agents (e.g., statins, ezetimibe, cholestyramine, nicotinic acid, fibrates, etc.) 5. Individuals who have experienced a weight change of more than 5% within 1 month (30 days) prior to Visit 1, or are currently undergoing a weight control program. 6. Individuals who smoke excessively (20 or more cigarettes per day). 7. Individuals who chronically consume alcohol.\* \* Defined as average alcohol consumption exceeding 40 g/day (280 g/week) for men or 20 g/day (140 g/week) for women. 8. Individuals with AST (GOT) or ALT (GPT) levels =3 times the upper limit of normal for the institution. 9. Individuals with TSH levels =0.1 µIU/mL or =10 µIU/mL. 10. Individuals with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m². 11. Individuals with uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg, measured after 10 minutes of rest). 12. Pregnant or breastfeeding women, or individuals planning to become pregnant during the study period. 13. Individuals who have participated in another interventional clinical trial (including human studies) within 3 months prior to Visit 1, or who plan to participate in another interventional clinical trial during the study period. 14. Individuals who are sensitive or allergic to the components of the test food (test product or control product). 15. Individuals deemed unsuitable by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose (Fasting, Postprandial) | — |
Secondary
| Measure | Time frame |
|---|---|
| OGTT, HbA1c, Insulin, HOMA-IR, Adiponectin | — |
Countries
Korea, Republic of
Contacts
Public ContactSEUNG-HYUN KANG
H Plus Yangji Hospital
Outcome results
None listed