Skip to main content
Clinical Trials/NCT04764526
NCT04764526CompletedNot Applicable

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

Inge Tetens2 sites in 1 country8 target enrollmentStarted: April 14, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8
Locations
2
Primary Endpoint
Protein intake (g, %)

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Protein intake (g, %)

Time Frame: four consecutive days while hospitalized

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

Secondary Outcomes

  • Evoked emotions(one day while hospitalized (first time the patients is offered a protein-enriched ice cream))
  • Energy intake (kJ, %)(four consecutive days while hospitalized)

Investigators

Sponsor
Inge Tetens
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Inge Tetens

Professor

University of Copenhagen

Study Sites (2)

Loading locations...

Similar Trials