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CompletedNCT07231666GoldilocksUpdated Nov 17, 2025

Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements

An interventional study of water and semi skimmed milk or powerade in Ileostomy - Stoma and Intestinal Failure, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by University of Aarhus · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2021, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Ileostomy - Stoma
  • Intestinal Failure

Keywords

  • Ileostomy
  • osmolality
  • natriuresis
  • dehydration
  • electrolyte
03

In context

Intestinal Failure

64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's enrollment of 14 is below the median of 38 across 42 interventional studies indexed under Intestinal Failure.

Browse Intestinal Failure studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age 18 years or higher
  2. ileostomy formed at least 8 weeks before enrolment
  3. consent to participate

Exclusion criteria

Exclusion Criteria:

  1. pregnancy
  2. known chronic kidney disease
  3. known diabetes mellitus
  4. too long driving distance
  5. parenteral nutrition/fluid more than 6 litres per month
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
14 participants (actual)

Study arms

  • Active comparator
    hypoosmolar

    One with a hypo-osmolar fluid

    Dietary Supplement: water

  • Active comparator
    isoosmolar

    one with an iso-osmolar fluid

    Dietary Supplement: semi skimmed milk or powerade

  • Active comparator
    hyperosmolar

    one with a hyper-osmolar

    Dietary Supplement: juice

Interventions

  • Dietary supplementwater

    oral commercially available supplements

  • Dietary supplementsemi skimmed milk or powerade

    oral commercially available supplements

  • Dietary supplementjuice

    oral commercially available supplements

06

What researchers measure

Primary outcomes

  1. ileostomy output

    ileostomy output (wet weight feces grams)

    Time frame: 6 hours

Secondary outcomes

  1. natriuresis

    urine volume (mL)

    Time frame: 6 hours

  2. urine sodium

    urine sodium mmol

    Time frame: 6 hours

  3. urine osmolality

    urine osmolality (mmol/kg)

    Time frame: 6 hours

07

Study locations

2 sites
  • Department of medicine V (Hepatology and Gastroenterology)
    Aarhus C, 8000, Denmark
  • Aarhus University Hospital
    Aarhus N, 8200, Denmark
08

References and documents

Publications

  • 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. PubMed 38777478 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07231666
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 11, 2021
Primary completion
Jul 30, 2022
Completion
Oct 31, 2022
Last update
Nov 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Water

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