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Completed

NCT Number: NCT04764526

Ice Cream Enriched With Protein and Positive Emotions

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

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Key information

Conditions

Protein Intake

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein-enriched ice cream

Other

Offering two protein-enriched ice creams

Primary outcomes

  1. Protein intake (g, %)

    Time frame: four consecutive days while hospitalized

    The change in protein intake with and without protein-enriched ice cream.

Secondary outcomes

  1. Energy intake (kJ, %)

    Time frame: four consecutive days while hospitalized

    The change in energy intake with and without protein-enriched ice cream.

  2. Evoked emotions

    Time frame: one day while hospitalized (first time the patients is offered a protein-enriched ice cream)

    Check-all-that-apply (CATA) emotions word questionnaire

Sponsors and collaborators

Lead sponsor

Inge Tetens

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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