None listed
Conditions
Interventions
None listed
Sponsors
Samyang Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult participants of both genders aged between 19 to 75 yrs. 2. Participants willing to give a voluntary written informed consent and come for regular follow-up with a subject. 3. Participants willing to abide by and comply with the study Protocol. 4. Normal physical activity confirmed with physical, clinical examination, and routine laboratory tests, including CBC, HbA1c, Insulin and Fasting Blood Sugar, LFT, RFT, lipid profile measurement of oral temperature and recording vital signs.
Exclusion criteria
Exclusion criteria: 1. Participation in other clinical trials 2. Participants with a history of psychiatric illness 3. Participants who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment 4. Participants with any gastrointestinal disorders or symptoms such as lactose intolerance heartburn indigestion or severe constipation 5. Participants who have regularly consumed foods or health supplements that may affect gut health within one month prior to the first visit such as probiotics prebiotics dietary fiber or FOS 6. Participants with a high habitual dietary fiber intake such as Recommended Food Score more than thirty six 7. Participants who have regularly consumed functional sweeteners within two weeks prior to the first visit such as xylose tagatose stevia or oligosaccharides 8. Participants who in the opinion of the Investigator or the Expert physician are not eligible for enrolment in the study 9. Participants with illnesses which may conflict with the investigators interpretation if they participated in the study 10. Participants who are currently taking any medication that may interfere with the study outcome 11. Pregnant or lactating women 12. Participants with any neoplastic metabolic and cardiovascular disorder or other concurrent medical illness such as type one or type two diabetes renal disease mal absorptive disorders acute or chronic inflammation confirmed based on medical history physical examination and routine laboratory tests including oral temperature white blood cell count and stool analysis 13. Participants with known history of hypersensitivity to the investigational product 14. Alcohol consumers and smokers
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| -Change in gastrointestinal symptom scores such as mGSRS at day 15 and Weeks 4 8 and 12 -Change in Pittsburgh Sleep Quality Index total score from baseline to Weeks 4 8 and 12 -Change in Global Physical Activity Questionnaire scores from baseline to Weeks 4 8 and 12 -Change in stool consistency based on the Bristol Stool Chart at Weeks 4 8 and 12 -Proportion of participants with at least one gastrointestinal related treatment emergent adverse event such as abdominal pain bloating diarrhea or constipation from Day 1 to Week 12 -Proportion of participants with at least one serious adverse event from Day 1 to Week 12 -Proportion of participants who discontinue study intervention due to adverse events -Proportion of participants with clinically significant abnormal laboratory values including complete blood count liver function tests renal function tests HbA1c insulin fasting blood sugar and lipid profile at follow up compared with baseline Timepoint: Week 0 (Day 1) Week 4 (Day 28 2 Days) Week 8 (Day 56 2 Days) Week 12 (Day 84 2 Days)(EOT/S) | — |
Primary
| Measure | Time frame |
|---|---|
| -Safety endpoint Proportion of participants experiencing at least one treatment emergent adverse event from Week 0 Day 1 to Week 12 Day 84 plus or minus two days in each intervention arm -Gastrointestinal tolerance endpoint Change in Modified Gastrointestinal Symptom Rating Scale total score from baseline Week 0 to Week 12 Day 84 plus or minus two days comparing crystalline Kestose versus placeboTimepoint: Week 0 (Day 1) Week 4 (Day 28 2 Days) Week 8 (Day 56 2 Days) Week 12 (Day 84 2 Days)(EOT/S) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed