Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements

NCT07231666 | Completed

• 1 other identifier: 1-10-72-289-21
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy

Conditions

Ileostomy - Stoma; Intestinal Failure

Keywords

Ileostomy; osmolality; natriuresis; dehydration; electrolyte

Outcome Measures

Primary Outcomes (1)

• ileostomy output

  ileostomy output (wet weight feces grams)

  6 hours

Secondary Outcomes (3)

• natriuresis

  6 hours

• urine sodium

  6 hours

• urine osmolality

  6 hours

Study Arms (3)

hypoosmolar

ACTIVE COMPARATOR

One with a hypo-osmolar fluid

Dietary Supplement: water

isoosmolar

ACTIVE COMPARATOR

one with an iso-osmolar fluid

Dietary Supplement: semi skimmed milk or powerade

hyperosmolar

ACTIVE COMPARATOR

one with a hyper-osmolar

Dietary Supplement: juice

Interventions

water DIETARY_SUPPLEMENT

oral commercially available supplements

hypoosmolar

semi skimmed milk or powerade DIETARY_SUPPLEMENT

oral commercially available supplements

isoosmolar

juice DIETARY_SUPPLEMENT

oral commercially available supplements

hyperosmolar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or higher
• ileostomy formed at least 8 weeks before enrolment
• consent to participate

You may not qualify if:

• pregnancy
• known chronic kidney disease
• known diabetes mellitus
• too long driving distance
• parenteral nutrition/fluid more than 6 litres per month

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of medicine V (Hepatology and Gastroenterology)

Aarhus C, 8000, Denmark

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38777478 RESULT

MeSH Terms

Conditions

Intestinal Failure; Dehydration

Interventions

Water; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: November 17, 2025
• Study Start: November 11, 2021
• Primary Completion: July 30, 2022
• Study Completion: October 31, 2022
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

DK (2)