Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements (Goldilocks)

November 14, 2025 updated by: University of Aarhus

Goldilocks' Zone: Optimised Osmolality in Supplements for the Patient With an Ileostomy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hypoosmolar
One with a hypo-osmolar fluid
Dietary supplement: water
oral commercially available supplements
Active Comparator: isoosmolar
one with an iso-osmolar fluid
Dietary supplement: semi skimmed milk or powerade
oral commercially available supplements
Active Comparator: hyperosmolar
one with a hyper-osmolar
Dietary supplement: juice
oral commercially available supplements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ileostomy output
Time Frame: 6 hours
ileostomy output (wet weight feces grams)
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
natriuresis
Time Frame: 6 hours
urine volume (mL)
6 hours
urine sodium
Time Frame: 6 hours
urine sodium mmol
6 hours
urine osmolality
Time Frame: 6 hours
urine osmolality (mmol/kg)
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-289-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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