Gastrointestinal Tolerance of D-allulose in Children

Tate & Lyle

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: D-allulose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06063096

TateLyle

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Allulose Dose 1

Active Comparator group

Description:

Fruit-flavoured drink with allulose at Dose 1 (2.5 g per 120 ml)

Treatment:

Dietary Supplement: D-allulose

Allulose Dose 2

Active Comparator group

Description:

Fruit-flavoured drink with allulose at Dose 2 (4.3 g per 120 ml)

Treatment:

Dietary Supplement: D-allulose

Placebo Comparator: Control (CON)

Placebo Comparator group

Description:

Control drink containing high fructose corn syrup.

Treatment:

Dietary Supplement: Placebo