Gastrointestinal Tolerance of D-allulose in Children

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06063096
• Other study ID #: TateLyle
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: March 3, 2016

Study information

• Verified date: September 2023
• Source: Tate & Lyle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 3, 2016
• Est. primary completion date: March 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• D-allulose
Fruit-flavoured drink with d-allulose at 2 dosages
• Placebo
Fruit-flavoured drink with high fructose corn syrup

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tate & Lyle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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