Gastrointestinal Tolerance of D-allulose in Children

Study Overview
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Brief Summary
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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.

Official Title
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Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: D-allulose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Acute, randomised, double-blind, placebo-controlled, cross-over
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allulose Dose 1<br>Fruit-flavoured drink with allulose at Dose 1 (2.5 g per 120 ml) | Dietary Supplement: D-allulose<br>* Fruit-flavoured drink with d-allulose at 2 dosages<br>|
| Active Comparator: Allulose Dose 2<br>Fruit-flavoured drink with allulose at Dose 2 (4.3 g per 120 ml) | Dietary Supplement: D-allulose<br>* Fruit-flavoured drink with d-allulose at 2 dosages<br>|
| Placebo Comparator: Placebo Comparator: Control (CON)<br>Control drink containing high fructose corn syrup. | Dietary Supplement: Placebo<br>* Fruit-flavoured drink with high fructose corn syrup<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | within 24 hours after study product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | in a 24-hour period post-consumption of intervention | 
| 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 | 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). | in the 24-hour period post-consumption |