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

Not Applicable

Completed

• Conditions: Delayed Gastric Emptying; Malignant Disease; Hematological Disease
• Interventions: Other: dietary counselling

• Registration Number: NCT02447237
• Lead Sponsor: Jens Rikardt Andersen

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
solid food	dietary counselling	dietary counselling in fulfilling need of protein and energy through solid food
liquid food	dietary counselling	dietary counselling in fulfilling need of protein and energy through liquid food

Primary Outcome Measures

Name	Time	Method
Intake of energy and protein	14 days	assessed by dietary records from both groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hematological clinic; 🇩🇰 Copenhagen, Denmark