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NCT Number: NCT07231666

Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements

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

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Key information

Conditions

Ileostomy - Stoma Dehydration Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Intestinal Failure Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of medicine V (Hepatology and Gastroenterology), Aarhus C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Water

Dietary Supplement

oral commercially available supplements

semi skimmed milk or powerade

Dietary Supplement

oral commercially available supplements

Juice

Dietary Supplement

oral commercially available supplements

Primary outcomes

  1. ileostomy output

    Time frame: 6 hours

    ileostomy output (wet weight feces grams)

Secondary outcomes

  1. natriuresis

    Time frame: 6 hours

    urine volume (mL)

  2. urine sodium

    Time frame: 6 hours

    urine sodium mmol

  3. urine osmolality

    Time frame: 6 hours

    urine osmolality (mmol/kg)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: Goldilocks

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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