Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in each study part. The objective of the study is to investigate blood glucose levels after oral intake of defined amounts of lactulose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
CRO BioTeSys GmbH
Esslingen am Neckar, Germany
Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
Time frame: 0-180 min
Maximum blood glucose concentration (Cmax)
Time frame: 0-180 min
Maximum increase of blood glucose concentration (Max_increase)
Cmax minus baseline value
Time frame: 0-180 min
Relative maximum increase of blood glucose concentration(Max_increase rel)
Cmax / baseline value
Time frame: 0-180 min
Time to reach maximum blood glucose concentration (Tmax)
Time frame: 0-180 min
First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)
Time frame: 0-180 min
Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))
Time frame: 0-180 min
Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))
Area under curve from 0 to 180 min minus baseline\*180min
Time frame: 0-180 min
Adverse events (AEs)
Time frame: After screening till study day 22 (+24 hours)
Gastrointestinal tolerability (assessed by subject's questionnaire)
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Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
Time frame: 180 min
Gastrointestinal tolerability (assessed by subject's questionnaire)
Time frame: 24 hours post-dose