None listed
Conditions
Interventions
Intervention1: Kestose: Material name-Kestose
Synonyms- Beta D Fruf 2 1 Beta D Fruf 2 1 Alpha D Glup
Assay D S percent not less than 98 percent
Nature- Sucrose
EU No- 207 429 4
Chemical formula- 1 kes
1 sachet (2 g) 3 times daily after meals during Weeks 3 to 4
1 sachet (3 g) 3 times daily after meals during Weeks 5 to 8
1 sachet (4 g) 3 times daily after meals during Weeks 9 to 12.
Intervention3: 1-Kestose (Crystalline): 1.Weeks 1 to 2- Crystalline Kestose- 1 sachet (1 g) 3 times daily after meals.
2.Weeks 3 to 4-Cr
1 sachet (4 g) 3 times daily after meals during Weeks 9 to 12.
Control Interv
Sponsors
Samyang Corporation
Eligibility
Inclusion criteria
Inclusion criteria: -Healthy toddlers of both genders aged between 1 and 4 years. -The participantâ??s legal guardian is willing to provide voluntary written informed consent and agrees to complete all study related activities and attend regular follow up visits with the participant. -The participantâ??s legal guardian is willing to abide by and comply with the study protocol requirements. -Normal physical health as confirmed by physical examination, clinical assessment, and routine laboratory tests including complete blood count, HbA1c, insulin, fasting blood sugar, liver function tests, renal function tests, lipid profile, measurement of oral temperature, and vital signs.
Exclusion criteria
Exclusion criteria: -Participation in any other clinical trial. -Participants with a history of psychiatric illness. -Participants who are currently enrolled in an investigational study or who have participated in an investigational study within 30 days prior to enrolment. -Participants with any gastrointestinal disorder or symptoms such as lactose intolerance heartburn indigestion or severe constipation. -Participants who have regularly consumed foods or health supplements that may affect gut health within one month prior to the first study visit including probiotics prebiotics dietary fiber or fructo oligosaccharides. -Participants with a high habitual dietary fiber intake as assessed by dietary evaluation. -Participants who have regularly consumed functional sweeteners within two weeks prior to the first study visit including xylose tagatose stevia or oligosaccharides. -Participants who in the opinion of the Investigator or Expert Physician are not eligible for enrolment in the study. -Participants with any illness that may interfere with the Investigatorâ??s interpretation of the study results. -Participants who are currently taking any medication that may interfere with the study outcomes. -Participants with any neoplastic metabolic or cardiovascular disorder or other concurrent medical illness including type 1 or type 2 diabetes renal disease malabsorptive disorders or acute or chronic inflammatory conditions as confirmed by medical history physical examination and routine laboratory tests including oral temperature and white blood cell count. -Participants with a known history of hypersensitivity to the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Safety endpoint Proportion of participants experiencing at least one treatment emergent adverse event from Day 1 to Week 12 Day 84 plus or minus 2 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 2 days comparing crystalline kestose versus placebo.Timepoint: Day 1 Day 28±2 Days Day 56 ±2 Days Day 84 ±2 Days (EOT/S) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in gastrointestinal symptom scores eg mGSRS at Day 15 and Weeks 4 8 and 12 -Change in Pittsburgh Sleep Quality Index PSQI total score 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 GI related TEAE eg abdominal pain bloating diarrhea constipation from Day 1 to Week 12 -Proportion of participants with at least one serious adverse event SAE 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 CBC LFT RFT HbA1c insulin fasting blood sugar lipid profile at follow up compared with baseline -Changes in dietary intake parameters energy intake macronutrient intake and dietary fiber intake over the study period assessed using the Dietary Assessment ChartTimepoint: Day 1 Day 28±2 Days Day 56 ±2 Days Day 84 ±2 Days (EOT/S) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed