Gastrointestinal Tolerance of D-allulose in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: D-allulose; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tate & Lyle

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): March 3, 2016
• Study Completion (Actual): March 3, 2016

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TateLyle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No