None listed
Conditions
Interventions
Dietary Supplement : This is a 12-week, randomized, double-blind, placebo-controlled, two-arm parallel-group clinical trial in adults with prediabetes. Following screening and eligibility confirmation
Sponsors
ARIHNUS CO.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: Adult men or women aged =19 and <65 years Prediabetes, meeting at least one of the following: Fasting plasma glucose 100–125 mg/dL, or 2-hour plasma glucose 140–199 mg/dL during an OGTT No use of glucose-lowering medications within the past 3 months Able to understand the study procedures and provides written informed consent Able to comply with study product intake and scheduled visits throughout the study
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: 1. Diagnosed with diabetes mellitus or meeting diagnostic criteria for diabetes (e.g., fasting plasma glucose =126 mg/dL or 2-hour OGTT glucose =200 mg/dL) 2. Use of any glucose-lowering medication (including insulin) within the past 3 months 3. Use of medications that may significantly affect glycemic control (e.g., systemic corticosteroids) within the past 3 months or expected need during the study period, as judged by the investigator 4. Serious cardiovascular/cerebrovascular disease, uncontrolled hypertension, severe infectious disease, or any condition deemed inappropriate for participation by the investigator 5. Significant hepatic or renal impairment, or clinically meaningful abnormal laboratory findings, as judged by the investigator 6. History of major gastrointestinal surgery (e.g., gastrectomy, bowel resection) or malabsorption that may affect intake/absorption/metabolism of the study product, as judged by the investigator 7. Known hypersensitivity or allergy to broccoli, cruciferous vegetables, or any ingredient of the investigational or placebo product 8. Pregnant or breastfeeding, or planning pregnancy during the study period (including unwillingness to use effective contraception if of childbearing potential) 9. Participation in another clinical trial/human intervention study within the past 4 weeks or planned participation during the study period 10. Inability or unwillingness to discontinue supplements/functional foods that may affect blood glucose or body weight during the study period, as judged by the investigator 11. Alcohol or substance abuse, or significant psychiatric illness that may compromise compliance, as judged by the investigator 12. Any other condition that the investigator deems unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in fasting plasma glucose (FPG);Change from baseline to Week 12 in 2-hour plasma glucose during OGTT (2-hour post-load glucose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in OGTT glucose at 30, 60, and 90 minutes;Change from baseline to Week 12 in glycated hemoglobin (HbA1c);Change from baseline to Week 12 in insulin resistance index (HOMA-IR);Change from baseline to Week 12 in C-peptide (insulin secretory function marker);Change from baseline to Week 12 in hormone-related biomarkers (total GLP-1, insulin, adiponectin);Clinical laboratory tests (blood/urine) and vital signs (changes/abnormal findings);Incidence and number of adverse events (AEs) and serious adverse events (SAEs) during the study | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon MI Shin
Semyung University Oriental Medicine Hospital
Outcome results
None listed