Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04764526 |
Other study ID # |
M238 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 14, 2021 |
Est. completion date |
July 30, 2021 |
Study information
Verified date |
April 2021 |
Source |
University of Copenhagen |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The primary aim is to investigate if protein-enriched ice cream has the feasibility to
increase intake of protein without substituting other foods in hospitalized older patients
and secondary, if the protein-enriched ice cream has the feasibility to increases the energy
intake and evokes positive emotions in older hospitalized patients
Description:
Methods/Design:
This study is conducted as a four days non-blinded randomised cross-over feasibility study
with 24 hospitalized older patients. The intervention is conducted at the hospital. The
intervention is two days with two protein-enriched ice cream daily with the aim of increasing
the intake of protein and energy. The patients are asked to answer a questionnaire concerning
the emotions the protein enriched ice cream evoke.The patients will be randomised to receive
the standard menu the first two days followed by two days with standard menu plus
protein-enriched ice cream or in the opposite order. The randomisation will be done by using
sealed envelopes.
Recruitment:
Only admitted patients will be a part of the trial. The ward staff will identify the patients
there are eligible to the trial as close as possible to the day of admission. The ward staff
will ask those patients who meet the inclusion criteria if they will participate in the
trail. The patients receive oral and written information on the trial and those who agree to
participate are asked to sign a statement of consent before participating. The patients can
at any time withdraw their consent and leave the trial.
Sample size:
The sample size is estimated to 24 patients, who will be their own control.
Statistical analysis:
Non-parametric statistical tests, median and range will be performed due to the small sample
size and skew distribution. The Wilcoxon signed rank test for paired data, and Fisher's exact
test for categorical data. Evoked emotion are measured as the percentages of patients who
choose a particular emotion term.