None listed
Conditions
Interventions
Dietary Supplement : Test group: Subjects will take two capsules of VIXL03 orally one daily for 12 weeks.
Control group: Subjects will take two capsules of placebo orally one daily for 12 weeks.
Sponsors
Bumin Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adults aged = 19 years and < 65 years at the time of screening 2) Individuals with fasting plasma glucose (FPG) levels = 100 mg/dL and < 126 mg/dL, or those with FPG levels = 126 mg/dL and < 140 mg/dL who do not require pharmacological treatment or prescription medication 3) Individuals with glycated hemoglobin (HbA1c) levels = 5.7% and = 6.4% 4) Individuals who have voluntarily provided written informed consent to participate in this human clinical trial
Exclusion criteria
Exclusion criteria: 1) Individuals with a history of hypersensitivity or allergic reactions to mulberry leaf extract or other natural products 2) Individuals who have consumed foods containing mulberry leaf extract within 2 weeks prior to screening 3) Individuals who have taken or are currently taking systemic glucocorticoids within 3 months prior to screening 4) Individuals with a history of intake or administration of GLP-1–related products, or who are currently consuming or receiving GLP-1–related products, within 3 months prior to screening 5) Individuals with congenital deficiencies of carbohydrate-digesting enzymes 6) Individuals who have experienced a weight loss of = 10% within 3 months prior to screening 7) Individuals with hyperthyroidism or hypothyroidism (thyroid-stimulating hormone [TSH] 1.5 mg/dL, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × the upper limit of normal (ULN) 10) Individuals with gastrointestinal disorders (e.g., gastric ulcer, chronic dyspepsia, Crohn’s disease, ulcerative colitis) requiring continuous treatment or medication for more than 10 days 11) Individuals with chronic alcohol consumption (average daily intake > 30 g for men [> 210 g/week] or > 20 g for women [> 140 g/week]), or a history of alcohol or substance abuse 12) Individuals who have taken or are currently taking health functional foods or medications related to blood glucose control, or medications/foods for the treatment or improvement of obesity, diabetes, or dyslipidemia within 3 months prior to screening 13) Individuals who have received any investigational medicinal product or consumed any investigational food in another clinical trial within 3 months prior to screening 14) Pregnant or breastfeeding women, and women of childbearing potential who are unwilling to use appropriate contraception (oral contraceptives are not permitted) 15) Individuals currently taking antipsychotic medications or with a history of psychiatric disorders (e.g., psychosis, depression) 16) Individuals with a history of malignancy, including leukemia or lymphoma, within the past 5 years 17) Individuals who, in the opinion of the investigator, are unable to comply with the study requirements or are otherwise deemed unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OGTT(AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| OGTT(0min, 30min, 60min, 90min, 120min);Insulin;C-peptide;HOMA-IR;fasting blood glucose;Adiponectin, Leptin;GLP-1 ;Changes in serum lipid levels(TC, TG, LDL-C, HDL-C);OSTT AUC and 0min, 30min, 60min, 90min, 120min | — |
Countries
Korea, Republic of
Contacts
Public ContactJunhong Park
Bumin Hospital
Outcome results
None listed