None listed
Conditions
Interventions
Dietary Supplement : This study is a randomized, open-label, parallel-group clinical trial, with healthy adults assigned to a control group, Test Group 1, Test Group 2, Test Group 3, and Test Group 4.
Sponsors
HEM Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 years or older. 2) Individuals who are judged to be in overall good health based on their medical history. 3) Individuals who agree not to consume any gut health-related supplements other than the investigational product during the study period. 4) Individuals who agree not to consume any health functional foods or dairy products containing prebiotics or probiotics, other than the investigational product, during the study period. 5) Individuals who agree not to participate in any other interventional studies during the study period. 6) Individuals who voluntarily sign the informed consent form approved by the Public Institutional Bioethics Committee and are willing and able to comply with all procedures required by the study protocol.
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with Irritable Bowel Syndrome (IBS). 2) Individuals with a past or current history of chronic diseases, cancer, infections, or surgeries that could affect the study's evaluation variables. 3) Individuals who have had a medical or surgical event requiring hospitalization, outpatient care, or emergency room visits within the last year, or are deemed unsuitable for participation in the study by the judgment of the Principal Investigator/Sub-investigator. 4) Individuals with unstable or acute symptoms, or life-threatening diseases. 5) Individuals unable to provide a stool sample. 6) Individuals who regularly consume supplements for probiotics, prebiotics, energy, or mood improvement and are unwilling to stop consumption 1 week before screening and during the study period (such supplements include standalone probiotic products, vitamins containing probiotics, and probiotic-fortified foods). 7) Individuals on a galactose/lactose-restricted diet. 8) Individuals with a history of taking oral antibiotics within the last 3 months. 9) Individuals who have experienced significant changes in their dietary habits within the last month. 10) Individuals with an intolerance or allergy to sugar alcohols such as mannitol, sorbitol, xylitol, lactulose, or lactose. 11) Women who are breastfeeding, pregnant, or planning to become pregnant during the study period (next 2 months). 12) Individuals who are currently participating in another clinical study or have a history of participating in another clinical study within 6 months of screening. 13) Individuals who, in the judgment of the Principal Investigator, have a condition that makes participation, safe conduct of the study, or interpretation of the study results impossible or could cause confusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut health questionnair(Bowel movement frequency, bowel satisfaction, Bristol, abdominal discomfort) | — |
Secondary
| Measure | Time frame |
|---|---|
| fecal short-chain fatty acids (acetate, propionate, and butyrate) level;Quality of life score | — |
Countries
Korea, Republic of
Contacts
Public ContactSunyoung Lee
HEM Pharma
Outcome results
None listed