Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients

Study Overview
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Brief Summary
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The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.

Detailed Description
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The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.

Official Title
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Randomized Controlled Trial About the Effect of Liquid Compared to Solid Food on the Intake of Energy and Protein in Patients With Leukemia, Lymphoma or Other Malignant Hematologic Disease

Conditions
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Hematological Disease, Delayed Gastric Emptying, Malignant Disease

Intervention / Treatment
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* Other: dietary counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with leukemia, lymphoma or other malignant hematological disease adults be able to talk and understand danish be able to eat both solid and liquid food Exclusion Criteria: not able to cooperate need for total tube or parenteral nutrition need for dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liquid food<br>dietary counselling in fulfilling need of protein and energy through liquid food | Other: dietary counselling<br>* the participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food).<br>|
| Other: solid food<br>dietary counselling in fulfilling need of protein and energy through solid food | Other: dietary counselling<br>* the participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intake of energy and protein | assessed by dietary records from both groups | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weightloss change in percent from baseline | calculated by comparing baseline weight with the weight after 14 days | 14 days | 
| Amount of infections | infection, e.g. fever, diarrhoea will be assessed from the medical record | 14 days | 
| Need for tube feeding and parenteral nutrition | will be assessed from the medical record | 14 days | 
| patient satisfaction as well as perception of own nutritional status | will be assessed from a questionnaire filled out by the patient after completing the intervention | 14 days | 
| patients compliance of following the nutritional guidelines in the liquid group | calculating the amount of energy from liquid food compared to the total energy intake using the dietary records | 14 days | 
| Dose of cytostatics | will be assessed from the medical records | 14 days | 
| unplanned hospital stay | will be assessed from the medical record | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liquid diet, solid diet