Gastrointestinal Tolerance of D-allulose in Children

• Sponsor: Tate & Lyle (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06063096
• Collaborator: (none)
• Enrollment: 30
• Arms: 3
• Actual Duration (Months): 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: D-allulose; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Acute, randomised, double-blind, placebo-controlled, cross-overAcute, randomised, double-blind, placebo-controlled, cross-over
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study
• Actual Study Start Date: Dec 15, 2015
• Actual Primary Completion Date: Mar 3, 2016
• Actual Study Completion Date: Mar 3, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [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

Secondary Outcome Measures

1. 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]

   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

2. 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]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tate & Lyle

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tate & Lyle
• ClinicalTrials.gov Identifier: NCT06063096
• Other Study ID Numbers: TateLyle
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 2, 2023