Gastrointestinal Tolerance of D-allulose in Children

NCT06063096 | Completed

• 1 other identifier: TateLyle
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  in the 24-hour period post-consumption

Study Arms (3)

Allulose Dose 1

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

Allulose Dose 2

ACTIVE COMPARATOR

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

Dietary Supplement: D-allulose

Placebo Comparator: Control (CON)

PLACEBO COMPARATOR

Control drink containing high fructose corn syrup.

Dietary Supplement: Placebo

Interventions

D-allulose DIETARY_SUPPLEMENT

Fruit-flavoured drink with d-allulose at 2 dosages

Allulose Dose 1; Allulose Dose 2

Placebo DIETARY_SUPPLEMENT

Fruit-flavoured drink with high fructose corn syrup

Placebo Comparator: Control (CON)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tate & Lyle: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Acute, randomised, double-blind, placebo-controlled, cross-over

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: October 2, 2023
• Study Start: December 15, 2015
• Primary Completion: March 3, 2016
• Study Completion: March 3, 2016
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share