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

Primary Purpose

Hematological Disease, Delayed Gastric Emptying, Malignant Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
dietary counselling
Sponsored by
Jens Rikardt Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Disease focused on measuring liquid diet, solid diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hematological clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

liquid food

solid food

Arm Description

dietary counselling in fulfilling need of protein and energy through liquid food

dietary counselling in fulfilling need of protein and energy through solid food

Outcomes

Primary Outcome Measures

Intake of energy and protein
assessed by dietary records from both groups

Secondary Outcome Measures

Weightloss change in percent from baseline
calculated by comparing baseline weight with the weight after 14 days
Amount of infections
infection, e.g. fever, diarrhoea will be assessed from the medical record
Need for tube feeding and parenteral nutrition
will be assessed from the medical record
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
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
Dose of cytostatics
will be assessed from the medical records
unplanned hospital stay
will be assessed from the medical record

Full Information

First Posted
March 25, 2015
Last Updated
August 25, 2016
Sponsor
Jens Rikardt Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT02447237
Brief Title
Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Disease, Delayed Gastric Emptying, Malignant Disease
Keywords
liquid diet, solid diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
liquid food
Arm Type
Experimental
Arm Description
dietary counselling in fulfilling need of protein and energy through liquid food
Arm Title
solid food
Arm Type
Other
Arm Description
dietary counselling in fulfilling need of protein and energy through solid food
Intervention Type
Other
Intervention Name(s)
dietary counselling
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intake of energy and protein
Description
assessed by dietary records from both groups
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Weightloss change in percent from baseline
Description
calculated by comparing baseline weight with the weight after 14 days
Time Frame
14 days
Title
Amount of infections
Description
infection, e.g. fever, diarrhoea will be assessed from the medical record
Time Frame
14 days
Title
Need for tube feeding and parenteral nutrition
Description
will be assessed from the medical record
Time Frame
14 days
Title
patient satisfaction as well as perception of own nutritional status
Description
will be assessed from a questionnaire filled out by the patient after completing the intervention
Time Frame
14 days
Title
patients compliance of following the nutritional guidelines in the liquid group
Description
calculating the amount of energy from liquid food compared to the total energy intake using the dietary records
Time Frame
14 days
Title
Dose of cytostatics
Description
will be assessed from the medical records
Time Frame
14 days
Title
unplanned hospital stay
Description
will be assessed from the medical record
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, Lektor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Hematological clinic
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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