Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice as could be shown in a previous study
Single center, double-blind, randomized controlled cross-over trial with four treatments and four time points. The study has three primary objectives. The first primary objective is to confirm the in a previous study shown reduction of postprandial glycemic and insulinemic response after consumption of 500 ml glucose-free apple juice compared to 500 ml untreated apple juice. The second primary objective is to show the reduction of postprandial glycemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. The third primary objective is to show the reduction of insulinemic response after consumption of 250 ml glucose-free apple juice compared to 250 ml untreated apple juice. Secondary objectives include safety aspects, specifically the occurrence of diarrhoea in all four treatment groups, differences between treatment groups on the Bristol Stool Forms Scale, gastro-intestinal symptoms and laboratory parameters. In addition, gluconate excretion and excreted portion of ingested gluconate are of interest as well as faecal pH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
32
CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, Germany
iAUC glucose 500
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice
Time frame: 120 min after ingestion
iAUC insulin 500
iAUC insulin 500
Time frame: 120 min after ingestion
iAUC glucose 250
Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice
Time frame: 120 min after ingestion
iAUC insulin 250
iAUC insulin 250
Time frame: 120 min after ingestion
diarrhea
Occurrence of diarrhoea as assessed by stool frequency and Bristol Stool Forms Scale (Lewis, 1997) (3 or more loose or liquid stools per day, definition according to the WHO)
Time frame: before and 60 and 120 minutes after ingestion with respect to the last 2 hours
gastro-intestinal symptoms
Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998)
Time frame: before and 60 and 120 minutes after ingestion with respect to the last 2 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.