PP113 - DOSE-DEPENDENT GASTROINTESTINAL TOLERABILITY OF D-ALLULOSE IN HEALTHY EUROPEAN ADULTS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
PP113
DOSE-DEPENDENT GASTROINTESTINAL TOLERABILITY OF D-ALLULOSE IN HEALTHY EUROPEAN ADULTS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
V. Biering1,*, B. Kaufmann2, J. Specht3, M. Anschütz4, R. S. Wedemeyer4, J. Walstab5, R. Böhm5, A. Warnke4,5
1Nutrition Science and Communication, 2Regulatory Affairs, Application Development & Nutrition Science and Communication, 3Regulatory Affairs, Savanna Ingredients GmbH & Co KG, Elsdorf, 4SocratTec R&D GmbH, Oberursel , 5SocratTec R&D GmbH, Erfurt, Germany
Rationale: Intake of dietary sugars contributes to obesity and T2D. D-allulose is a naturally occurring rare sugar with negligible energy. Although classified as GRAS by the FDA, data on gastrointestinal tolerability remain limited.
Methods: In this randomized, double-blind, placebo-controlled study, healthy European adults (N=48) received D-allulose at 0.3, 0.4, or 0.5 g/kg body weight (BW), administered twice daily for 7 days, or placebo (D-glucose, 0.5 g/kg BW twice daily). The primary endpoint was overall GI tolerance assessed by the Gastrointestinal Symptom Rating Scale (GSRS). Secondary endpoints included GSRS domains, stool frequency and consistency (Bristol Stool Form Scale, BSFS), global tolerability ratings, and adverse events (AEs).
Results: D-allulose was generally well tolerated. Higher doses were associated with increased GI symptoms, mainly indigestion, diarrhoea and abdominal discomfort, while reflux and constipation were largely unaffected. Total GSRS scores did not differ from placebo at 0.3 and 0.4 g/kg BW twice daily, but were significantly increased at 0.5 g/kg BW twice daily. Stool frequency increased slightly with dose, and fast-transit stools (BSFS 6–7) occurred in ~50% of participants at the highest dose. Global tolerability ratings were consistent with these findings, and no intervention-related AEs were reported.
Conclusion: D-allulose was well tolerated at daily intakes up to 0.8 g/kg BW, with GI responses comparable to placebo. At 1.0 g/kg BW/day, the frequency of mild, non-serious GI symptoms and softer stools increased, without safety concerns. These results provide the first systematic tolerability data in a European population and support the use of D-allulose at moderate intake levels while indicating upper thresholds linked to reduced GI comfort.
Disclosure of Interest: None declared