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Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose tolerance with either one of the 5 study products
Primary endpoints:
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Objectives Primary objectives
Subjects and methods Study product A. Sucrose 50 g B. Sucrose 50 g + D-allulose (psicose) 2.5 g C. Sucrose 50 g + D-allulose (psicose) 5 g D. Sucrose 50 g + D-allulose (psicose) 7.5 g E. Sucrose 50 g + D-allulose (psicose) 10 g
Study plan Screening (visit 0)
Visit 1: (day 7 or 6-11 days)
Visit 2: (day 7 or 6-11 days from visit 1)
Visit 3 (day 7 or 6-11 days from visit 2)
Visit 4 (day 7 or 6-11 days from visit 3)
Visit 5 (day 7 or 6-11 days from visit 4)
Adverse Event Assessment At each visit, participants will be asked an open question as if he/she has experienced any abnormal symptoms. Any symptom reported by the participants will be recorded as an adverse events with details of the event, its severity, start and stop dates, and relationship to study products. Gastrointestinal symptoms (heartburn, distension, nausea, vomiting, abdominal pain, flatulence, constipation and diarrhea) within 24 hours after OSTT will be asked and recorded as well.
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30 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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