None listed
Conditions
Interventions
Dietary Supplement : This study is a randomized, double-blind, parallel-group clinical trial in which healthy adults are assigned to a control group, test group 1, or test group 2. All participants wi
Sponsors
HEM Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 19 years or older 2) Individuals with a body mass index (BMI) of = 29.9 kg/m² 3) Individuals who are generally healthy based on medical history 4) Individuals who agree not to consume any gut health-related functional foods other than the investigational product during the study period 5) Individuals who agree not to consume any functional foods or dairy products containing prebiotics or probiotics other than the investigational product during the study period 6) Individuals who agree not to participate in any other interventional study during the study period 7) Individuals who voluntarily sign the informed consent form approved by the Public Institutional Bioethics Committee and are willing and able to comply with all study procedures
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with irritable bowel syndrome (IBS) 2) Individuals with a history or current presence of chronic diseases, cancer, infection, or surgery that may affect study outcomes 3) Individuals who have experienced medical or surgical events requiring hospitalization, outpatient care, or emergency room visits within the past year, or who are considered unsuitable for participation at the discretion of the investigator 4) Individuals with unstable, acute, or life-threatening conditions 5) Individuals unable to provide stool samples 6) Individuals who regularly consume probiotics, prebiotics, or supplements for energy or mood improvement and are unwilling to discontinue their use during the study period and for at least one week prior to screening (including probiotic-only products, probiotic-containing vitamins, and probiotic-fortified foods) 7) Individuals on a galactose- or lactose-restricted diet 8) Individuals with a history of oral antibiotic use within the past 3 months 9) Individuals who have experienced significant changes in dietary habits within the past 1 month 10) Individuals with intolerance or allergy to sugar alcohols such as mannitol, sorbitol, xylitol, lactulose, or lactose 11) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period (within the next 2 months) 12) Individuals currently participating in another clinical study or who have participated in another clinical study within 6 months prior to screening 13) Individuals who, in the opinion of the investigator, are unable to safely participate in the study or may interfere with the interpretation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut health questionnaire score (Not intended as a primary efficacy endpoint in this exploratory clinical trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| Qulity of life score;fecal zonulin levels;fecal short-chain fatty acid (SCFA) levels;Fecal tryptophan metabolite levels;Gut microbiome | — |
Countries
Korea, Republic of
Contacts
Public ContactAhyoung Hwang
HEM Pharma
Outcome results
None listed