Healthy individuals Healthy Volunteers Sweetening Agents Glucose Insulin
Conditions
Interventions
a natural sweetener ,a natural sweetener ,a natural sweetener,artificial sweetener,caloric sweetener
Experimental Other,Experimental Other,Experimental Other,Experimental Other,Active Comparator Other
formulation 1 ,formulaion 2 ,formulation 3,Sucralose,Sucrose
Sponsors
Program Management Unit Competitiveness (PMUC)
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Has age between 20 to 45 years at the time of screening 2. Has body mass index (BMI) within the range of 18.5 to 22.9 kg/m2 at the time of screening 3. Has general good health based on medical history, physical examination, and basic laboratory tests (including complete blood count, serum electrolytes, liver function test, and renal function test) 4. Has the Dutch Eating Behaviour Questionnaire (DEBQ) score < 3 5. Is not a regular user of non-nutritive sweeteners and not a habitual consumer of sweetener products 6. Is able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1)Has a presence of any severe co-morbidity(ies), uncontrolled medical condition(s), or medical illness(es) which, in the judgment of the principal investigator, could have a substantial impact on the trial's results (particularly diseases known to affect diet consumption, glucose response, or insulin response); 2. Is vegetarian, vegan, or following a halal diet, or being unable to adhere to a regular diet; 3. Is on a weight-loss diet, has experienced weight cycles within the last 3 months, or has a weight change of more than 5 kg in the past 12 months; 4. Engages in more than 10 hours of intense physical activity per week or works continuous night or late shifts; 5. Has a history of hypersensitivity to any ingredients in the investigational products; 6. Has any other condition(s) in which any ingredients in the investigational product are contraindicated; 7. Has any other condition(s) that affects swallowing or consumption of the investigational products; 8. Has a problem(s) with alcoholism, substance abuse, or heavy smoking; 9. Takes medication for, or has a history of, medical conditions affecting body weight, appetite, and 10. gastrointestinal function (e.g., diabetes mellitus, inflammatory bowel diseases, surgical treatment of obesity, history of cancer, cardiovascular disease, cirrhosis, unstable thyroid disease, psychiatric illness, low-dose antidepressants, or cholesterol-lowering medications); 11. Participates in another clinical trial concurrently or within 30 days prior to the screening visit; Has a plan to have a baby, or is known or suspected to be pregnant, or is breastfeeding (for female patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose response 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes (Visit 1, 2, 3, 4, 5) Plasma glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin response 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes (Visit 1, 2, 3, 4, 5) Serum insulin,Appetite response 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes (Visit 1, 2, 3, 4, 5) Appetite score (VAS),Liking and wanting Visit 1, 2, 3, 4, and 5 VAS score,Energy intake Visit 1, 2, 3, 4, and 5 24 dietary recall,Adverse events Visit 1, 2, 3, 4, and 5 Adverse events | — |
Countries
Thailand
Contacts
Public ContactMingkwan Na Takuathung
Faculty of Medicine, Chiang Mai University
Outcome results
None listed