Ice Cream Enriched With Protein and Positive Emotions

NCT04764526 | Completed

• 1 other identifier: M238
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Protein Intake

Keywords

Protein-enrichment; Older hospitalized patients

Outcome Measures

Primary Outcomes (1)

• Protein intake (g, %)

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

  four consecutive days while hospitalized

Secondary Outcomes (2)

• Energy intake (kJ, %)

  four consecutive days while hospitalized

• Evoked emotions

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

Study Arms (2)

Protein-enriched ice cream

EXPERIMENTAL

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

Other: Protein-enriched ice cream

Control

NO INTERVENTION

Standard menu in two days

Interventions

Protein-enriched ice cream OTHER

Offering two protein-enriched ice creams

Protein-enriched ice cream

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• terminally ill, tube feed, need of special diets, any medical indication suggesting that they should not participate or are on a weight reduction scheme

Sponsors & Collaborators

• Inge Tetens: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Officials

• Inge Tetens, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The participant will be their own control and will be randomised to start with control followed by intervention or the opposite order.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 14, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)