Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTD-allulose
Fruit-flavoured drink with d-allulose at 2 dosages
DIETARY_SUPPLEMENTPlacebo
Fruit-flavoured drink with high fructose corn syrup
Sponsors
Tate & Lyle
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Acute, randomised, double-blind, placebo-controlled, cross-over
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | within 24 hours after study product intake | Difference in the number of subjects experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | in a 24-hour period post-consumption of intervention | Stool frequency, measured as the 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 |
| 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 | in the 24-hour period post-consumption | Report common gastrointestinal symptoms including abdominal pain, bloating, cramping, abdominal rumbling, excess flatus, and and nausea associated with d-allulose consumption. These were reported as the frequency of the event and frequency of participants reporting 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. The severity of the event was categorized in three levels (mild, moderate, severe). |
Outcome results
None listed