None listed
Conditions
Interventions
Dietary Supplement : Participants in Group A were instructed to follow a lifestyle modification plan. In contrast, participants in Group B were instructed to take the intervention drug (non-digestible
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults aged between 19 and 75 years at the time of consent. (2) Individuals with normal fasting blood glucose levels (below 100 mg/dL) or prediabetes (fasting blood glucose 100–125 mg/dL) based on a health check-up conducted within the last two years. (3) Individuals who can actively cooperate with the procedures of the decentralized clinical trial. (4) Individuals who have listened to a detailed explanation of this clinical trial, fully understood it, and voluntarily decided to participate by providing consent before the screening test.
Exclusion criteria
Exclusion criteria: (1) Individuals with clinically significant liver, kidney, neurological, respiratory, endocrine, hematologic, oncologic, cardiovascular, urologic, or psychiatric diseases, or those with a history of such conditions. (2) Individuals who have taken hypoglycemic agents within the last three months. (3) Pregnant or breastfeeding women, or those planning to become pregnant. (4) Individuals with a clinically significant allergy or hypersensitivity to the health supplement to be administered, or those who have experienced such reactions in the past. (5) Individuals with fasting blood glucose levels of 126 mg/dL or higher during the screening test. (6) Excessive alcohol consumers (men = 40 g/day, women = 20 g/day). (7) Heavy smokers (= 20 cigarettes/day). (8) Individuals who have taken health supplements related to the function being studied within three months prior to the start of the trial. (9) Individuals whom the investigator deems unsuitable for participation in the clinical trial for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant experience, Exploratory efficacy assessment, Exploratory fecal microbiome test | — |
Countries
Korea, Republic of
Contacts
Public ContactYoonjin Kim
Seoul National University Hospital
Outcome results
None listed