Clinical trial NCT04764526: Ice Cream Enriched With Protein and Positive Emotions
Official title: Can Protein-enriched Ice Cream Increase Protein- and Energy Intake and at the Same Time Evoke Positive Emotions - a Feasibility Study Among Hospitalized Older Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Intake
Keywords: Protein-enrichment
Older hospitalized patients
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 8
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participant will be their own control and will be randomised to start with control followed by intervention or the opposite order.
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Protein intake (g, %)
timeFrame: four consecutive days while hospitalized
Secondary outcomes:
measure: Energy intake (kJ, %)
timeFrame: four consecutive days while hospitalized
measure: Evoked emotions
timeFrame: one day while hospitalized (first time the patients is offered a protein-enriched ice cream)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: University of Copenhagen
name: Inge Tetens, PhD
role: PRINCIPAL_INVESTIGATOR
References: