An interventional study of D-allulose and Placebo in Healthy, sponsored by Tate & Lyle. Completed. Open to participants aged 6 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Tate & Lyle · Not applicable, Interventional, and Prevention
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.
Tate & Lyle is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fruit-flavoured drink with allulose at Dose 1 (2.5 g per 120 ml)
Dietary Supplement: D-allulose
Fruit-flavoured drink with allulose at Dose 2 (4.3 g per 120 ml)
Dietary Supplement: D-allulose
Control drink containing high fructose corn syrup.
Dietary Supplement: Placebo
Fruit-flavoured drink with d-allulose at 2 dosages
Fruit-flavoured drink with high fructose corn syrup
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
Time frame: within 24 hours after study product intake
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
Time frame: 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).
Time frame: in the 24-hour period post-consumption
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tate & Lyle