Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.
Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrolysed whey | Experimental | Hydrolysed whey |
|
| Intact whey | Active Comparator | Intact whey |
|
| Caseinate | Placebo Comparator | Caseinate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolysed whey | Dietary Supplement | 500 mL solution of 25 gram hydrolysed whey per day during 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour fecal wet weight | Difference in mean ileostomy output (wet weight) during 24 hours at the end of each intervention period | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diuresis | 24 hour urine volume | 4 weeks |
| Natriuresis | 24 hour urine sodium excretion | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian L Hvas, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38850996 | Derived | Rud CL, Hvistendahl MK, Langdahl B, Kraglund F, Baunwall SMD, Lal S, Jeppesen PB, Hvas CL. Protein-based oral rehydration solutions for patients with an ileostomy: A randomised, double-blinded crossover study. Clin Nutr. 2024 Jul;43(7):1747-1758. doi: 10.1016/j.clnu.2024.05.038. Epub 2024 May 28. |
Not provided
Not provided
Anonymised data or selections herof will be shared upon specific agreements and with researchers who have legitimate causes, following contact to the PI
upon request, after publication
contact to PI
Not provided
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Production in separate facility, randomisation key kept by third party
| Intact whey | Dietary Supplement | 500 mL solution of 25 gram intact whey per day during 4 weeks |
|
| Caseinate | Dietary Supplement | 500 mL solution of 25 gram casein ate per day during 4 weeks |
|
| Amino acid absorption | Plasma amino acids | 6 hours |
| Gastric and small bowel emptying | 3D transit evaluation | 6 hours |
| GLP1 and GLP2 | Intestinal hormones during absorption | 6 hours |
| Portosystemic hepatic encephalopathy (PSE) test score, median value | Pen and paper test, score with range | 4 weeks |
| Portosystemic hepatic encephalopathy (PSHE) test score abnormal (<4) | Pen and paper test, score with range | 4 weeks |
| Continuous reaction time (CRT) index median | Reaction to 150 sound stimuli, read-out as index compared to normal values | 4 weeks |
| Physical activity | Telemetric sensor | 4 weeks |
| Body weight (kg) | Bio-impedance analysis (SECA) | 4 weeks |
| Total body water (L) | Bio-impedance analysis (SECA) | 4 weeks |
| Extracellular water (L) | Bio-impedance analysis (SECA) | 4 weeks |
| Skeletal muscle mass (kg) | Bio-impedance analysis (SECA) | 4 weeks |
| Fat-free mass (kg) | Bio-impedance analysis (SECA) | 4 weeks |
| Fat mass (kg) | Bio-impedance analysis (SECA) | 4 weeks |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |