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临床试验/NCT04764526
NCT04764526已完成不适用

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 Tetens1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Protein intake (g, %)

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Control

No Intervention

Standard menu in two days

Protein-enriched ice cream

Experimental

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

干预措施: Protein-enriched ice cream (Other)

结局指标

主要结局

Protein intake (g, %)

时间窗: four consecutive days while hospitalized

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

次要结局

  • 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)

研究者

发起方
Inge Tetens
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Inge Tetens

Professor

University of Copenhagen

研究点 (1)

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