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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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - older admitted hospital patients age 65 or older, capable & Danish speaking (able to read and understand the oral and written information and give written consent), able to eat, eat ice cream and expected to stay at the hospital least four days. Exclusion Criteria: - terminally ill, tube feed, need of special diets, any medical indication suggesting that they should not participate or are on a weight reduction scheme

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Protein-enriched ice cream
Offering two protein-enriched ice creams

Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Inge Tetens

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protein intake (g, %) The change in protein intake with and without protein-enriched ice cream. four consecutive days while hospitalized
Secondary Energy intake (kJ, %) The change in energy intake with and without protein-enriched ice cream. four consecutive days while hospitalized
Secondary Evoked emotions Check-all-that-apply (CATA) emotions word questionnaire one day while hospitalized (first time the patients is offered a protein-enriched ice cream)
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