Clinical trial NCT06063096: Gastrointestinal Tolerance of D-allulose in Children
Official title: Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Tate & Lyle
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute, randomised, double-blind, placebo-controlled, cross-over
Primary purpose: PREVENTION

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 Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis.


Eligibility criteria: Inclusion Criteria:

1. Healthy children of 6 to 8 years of age
2. Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
3. Accustomed to having lunch between 12.00 pm and 2.30 pm
4. Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
5. Were able to drink 120 ml within 30 minutes
6. With parents willing to continue their child's normal food and beverage intake and physical activity throughout the duration of the study
7. With parents willing and able to attend for all 7 visits

Exclusion Criteria:

1. Any major trauma or surgical event within the 3 months prior to screening
2. History or presence of clinically significant endocrine or GI disorder
3. Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
4. 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
5. Use of any prescription medication, including antibiotics, laxatives and steroids
6. Regular GI complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
7. Known intolerance or sensitivity to any of the study products, abdominal or anorectal surgery
8. Psychiatric disorders, anxiety, and depression
9. Lactose intolerance
10. Use of supplements that may have affected GI system including laxatives, fibre, and iron supplements
11. Exposure to any non-registered drug product within 30 days prior to screening visit.

Primary outcomes:
measure: Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake
timeFrame: within 24 hours after study product intake
Secondary outcomes:
measure: Number of subjects who experienced at least one loose or watery stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
timeFrame: in a 24-hour period post-consumption of intervention
measure: Frequency of the GI symptom event and frequency of participants reporting GI symptoms events by the severity and causality (i.e., related, not related) for each treatment group recorded at Visits 3, 5 and 7, for pre- and post-dose administration
timeFrame: in the 24-hour period post-consumption
Other outcomes:
Locations:
Study officials:
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