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Ice Cream Enriched With Protein and Positive Emotions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04764526
Enrollment
8
Registered
2021-02-21
Start date
2021-04-14
Completion date
2021-07-30
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Intake

Keywords

Protein-enrichment, Older hospitalized patients

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.

Interventions

OTHERProtein-enriched ice cream

Offering two protein-enriched ice creams

Sponsors

Inge Tetens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Protein intake (g, %)four consecutive days while hospitalizedThe change in protein intake with and without protein-enriched ice cream.

Secondary

MeasureTime frameDescription
Energy intake (kJ, %)four consecutive days while hospitalizedThe change in energy intake with and without protein-enriched ice cream.
Evoked emotionsone day while hospitalized (first time the patients is offered a protein-enriched ice cream)Check-all-that-apply (CATA) emotions word questionnaire

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026