Status:
COMPLETED
Gastrointestinal Tolerance of D-allulose in Children
Lead Sponsor:
Tate & Lyle
Conditions:
Healthy
Eligibility:
All Genders
6-8 years
Phase:
NA
Brief Summary
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Gener...
Eligibility Criteria
Inclusion
- Healthy children of 6 to 8 years of age
- Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
- Accustomed to having lunch between 12.00 pm and 2.30 pm
- Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
- Were able to drink 120 ml within 30 minutes
- With parents willing to continue their child's normal food and beverage intake and physical activity throughout the duration of the study
- With parents willing and able to attend for all 7 visits
Exclusion
- Any major trauma or surgical event within the 3 months prior to screening
- History or presence of clinically significant endocrine or GI disorder
- Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
- More than 1 loose stool in the 48 hours preceding dosing, that met a Type 6 or Type 7 description on the Bristol Stool Chart
- Use of any prescription medication, including antibiotics, laxatives and steroids
- Regular GI complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
- Known intolerance or sensitivity to any of the study products, abdominal or anorectal surgery
- Psychiatric disorders, anxiety, and depression
- Lactose intolerance
- Use of supplements that may have affected GI system including laxatives, fibre, and iron supplements
- Exposure to any non-registered drug product within 30 days prior to screening visit.
Key Trial Info
Start Date :
December 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06063096
Start Date
December 15 2015
End Date
March 3 2016
Last Update
October 2 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.