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| Name | Class |
|---|---|
| Nofima | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum 500 | Active Comparator | 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. |
|
| control 500 | Placebo Comparator | 500 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) |
|
| verum 250 | Active Comparator | 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. |
|
| control 250 | Placebo Comparator | 250 ml conventional apple juice produced by a general apple juice production process (free glucose 17g/l) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 ml glucose-depleted apple juice | Other |
| ||
| 500 ml conventional apple juice |
| Measure | Description | Time Frame |
|---|---|---|
| iAUC glucose 500 | Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 500 ml juice | 120 min after ingestion |
| iAUC insulin 500 | iAUC insulin 500 | 120 min after ingestion |
| iAUC glucose 250 | Incremental AUC (iAUC120) of blood glucose levels (according to FAO/WHO) after 250 ml juice | 120 min after ingestion |
| iAUC insulin 250 | iAUC insulin 250 | 120 min after ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | before and 60 and 120 minutes after ingestion with respect to the last 2 hours |
| gastro-intestinal symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Laue, Dr. (MD) | CRC Clinical Research Center Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRC Clinical Research Center Kiel | Kiel | Schleswig-Holstein | 24118 | Germany |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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a double-blind randomised controlled cross-over trial
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The test products (verum and control) are similar in flavour, color, texture, appearance and identical in packaging to ensure the double-blind, controlled design of the study.
| Other |
|
| 250 ml glucose-depleted apple juice | Other |
|
| 250 ml conventional apple juice | Other |
|
Assessed by completing questionnaires on gastrointestinal symptoms (GSRS; Svedlund 1988; Dimenäs 1995; Revicki 1998) |
| before and 60 and 120 minutes after ingestion with respect to the last 2 hours |
| D004700 | Endocrine System Diseases |