An interventional study of 500 ml glucose-depleted apple juice and 500 ml conventional apple juice in Prediabetes, sponsored by Clinical Research Center Kiel GmbH. Completed at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Clinical Research Center Kiel GmbH · Not applicable, Interventional, and Other
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 32 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Clinical Research Center Kiel GmbH is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
500 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.
Other: 500 ml glucose-depleted apple juice
500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
Other: 500 ml conventional apple juice
250 ml low sugar apple juice manufactured from conventional apple juice via a series of enzymatic reactions that end up in a final content of free glucose less than 0,5 g/l.
Other: 250 ml glucose-depleted apple juice
250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l)
Other: 250 ml conventional apple juice
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Clinical Research Center Kiel GmbH