Gastrointestinal Tolerance of D-allulose in Children

Inclusion criteria

• 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 criteria

• 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.