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

University of Aarhus

Status: Completed

Conditions: Intestinal Failure; Ileostomy - Stoma

Treatments: Dietary Supplement: semi skimmed milk or powerade; Dietary Supplement: juice; Dietary Supplement: water

Study type: Interventional

Funder types: Other

Identifiers

NCT07231666

1-10-72-289-21

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 3 patient groups

hypoosmolar

Active Comparator group

Description:

One with a hypo-osmolar fluid

Treatment:

Dietary Supplement: water

isoosmolar

Active Comparator group

Description:

one with an iso-osmolar fluid

Treatment:

Dietary Supplement: semi skimmed milk or powerade

hyperosmolar

Active Comparator group

Description:

one with a hyper-osmolar

Treatment:

Dietary Supplement: juice