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Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy
14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypoosmolar | Active Comparator | One with a hypo-osmolar fluid |
|
| isoosmolar | Active Comparator | one with an iso-osmolar fluid |
|
| hyperosmolar | Active Comparator | one with a hyper-osmolar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| water | Dietary Supplement | oral commercially available supplements |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ileostomy output | ileostomy output (wet weight feces grams) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| natriuresis | urine volume (mL) | 6 hours |
| urine sodium | urine sodium mmol | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of medicine V (Hepatology and Gastroenterology) | Aarhus C | 8000 | Denmark | |||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38777478 | Result | Quist JR, Rud CL, Frumer K, Julsgaard M, Dahl Baunwall SM, Hvas CL. Osmolality in oral supplements drives ileostomy output: Defining the Goldilocks zone. Clin Nutr ESPEN. 2024 Jun;61:88-93. doi: 10.1016/j.clnesp.2024.03.003. Epub 2024 Mar 15. |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| D003681 | Dehydration |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| D014867 | Water |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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This was a single-centre, quasi-randomised cross-over intervention study. The effects of osmolality in oral supplements were investigated using a 3x3 cross-over design.
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The patients were randomised to receive either the hypo-osmolar or hyper-osmolar in their first intervention. Microsoft Excel feature "RAND" (Microsoft version 16) was used to randomize oral supplements. Each supplement was assigned a number. Every time a patient agreed to one or two more intervention periods, two supplements were randomized. One of the primary investigators (JQ) enrolled and randomized supplements to the patients
| semi skimmed milk or powerade |
| Dietary Supplement |
oral commercially available supplements |
|
| juice | Dietary Supplement | oral commercially available supplements |
|
| urine osmolality | urine osmolality (mmol/kg) | 6 hours |
| Aarhus N |
| 8200 |
| Denmark |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |