Ice Cream Enriched With Protein and Positive Emotions

NCT ID: NCT04764526

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2021-07-30

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.

Conditions

Protein Intake

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Protein-enriched ice cream

Two protein-enriched ice cream daily (afternoon and evening) in two days in addition to the normal menu

Group Type: EXPERIMENTAL

Protein-enriched ice cream

Intervention Type: OTHER

Offering two protein-enriched ice creams

Control

Standard menu in two days

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protein-enriched ice cream

Offering two protein-enriched ice creams

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inge Tetens

OTHER

Sponsor Role: lead

Responsible Party

Inge Tetens

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Inge Tetens, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

M238

Identifier Type: -

Identifier Source: org_study_id