Ileostomy - StomaGoldilocksNCT07231666
Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements
A study testing water, semi skimmed milk or powerade and juice in people with Ileostomy - Stoma and Intestinal Failure, run by University of Aarhus at 2 sites in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy - Stoma, Intestinal Failure
- What is being tested?
- water, semi skimmed milk or powerade and juice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Nov 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or higher
- ileostomy formed at least 8 weeks before enrolment
- consent to participate
Who cannot join
- pregnancy
- known chronic kidney disease
- known diabetes mellitus
- too long driving distance
- parenteral nutrition/fluid more than 6 litres per month
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of medicine V (Hepatology and Gastroenterology)
Aarhus C, 8000
Aarhus University Hospital
Aarhus N, 8200
About this study
Official title: 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
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.
- Conditions
- Ileostomy - Stoma, Intestinal Failure
- Being tested
- water, semi skimmed milk or powerade, juice
- Keywords
- Ileostomy, osmolality, natriuresis, dehydration, electrolyte
- Medical subject headings
- Intestinal Failure, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
waterDietary supplement
oral commercially available supplements
semi skimmed milk or poweradeDietary supplement
oral commercially available supplements
juiceDietary supplement
oral commercially available supplements
| Study group | Role | What they receive |
|---|---|---|
| hypoosmolar | Active comparator | One with a hypo-osmolar fluid Receives: Dietary Supplement: water |
| isoosmolar | Active comparator | one with an iso-osmolar fluid Receives: Dietary Supplement: semi skimmed milk or powerade |
| hyperosmolar | Active comparator | one with a hyper-osmolar Receives: Dietary Supplement: juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
ileostomy output
ileostomy output (wet weight feces grams)
Measured: 6 hours
Secondary outcomes (3)
natriuresis
urine volume (mL)
Measured: 6 hours
urine sodium
urine sodium mmol
Measured: 6 hours
urine osmolality
urine osmolality (mmol/kg)
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start11 Nov 2021
- Primary completion30 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231666
- Sponsor's protocol ID
- 1-10-72-289-21
- Acronym
- Goldilocks
- Status last verified
- Nov 2025
- First submitted
- 1 Aug 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goldilocks' Zone: Optimised Osmolality in Supplements for the Patient With an Ileostomy
- ClinicalTrials.gov ID
- NCT07231666
- Acronym / sponsor ID
- Goldilocks / 1-10-72-289-21
- Conditions
- Ileostomy - Stoma, Intestinal Failure
- Keywords
- Ileostomy, osmolality, natriuresis, dehydration, electrolyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| hypoosmolar | Active comparator | Dietary Supplement: waterOne with a hypo-osmolar fluid |
| isoosmolar | Active comparator | Dietary Supplement: semi skimmed milk or poweradeone with an iso-osmolar fluid |
| hyperosmolar | Active comparator | Dietary Supplement: juiceone with a hyper-osmolar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or higher
- ileostomy formed at least 8 weeks before enrolment
- consent to participate
Key exclusion criteria (5 listed)
- pregnancy
- known chronic kidney disease
- known diabetes mellitus
- too long driving distance
- parenteral nutrition/fluid more than 6 litres per month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wateroral commercially available supplements | Dietary supplement | hypoosmolar |
| semi skimmed milk or poweradeoral commercially available supplements | Dietary supplement | isoosmolar |
| juiceoral commercially available supplements | Dietary supplement | hyperosmolar |
Primary outcome
ileostomy output
Time frame: 6 hours
ileostomy output (wet weight feces grams)
3 secondary outcomes
natriuresis
Time frame: 6 hours
urine sodium
Time frame: 6 hours
urine osmolality
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 38777478Quist 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing water, semi skimmed milk or powerade and juice in people with Ileostomy - Stoma and Intestinal Failure, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ileostomy output (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07231666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.