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

Delayed Gastric Emptying Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447237
• Other study ID #: H-4-2014-113
• Status: Completed
• Phase: N/A
• First received: March 25, 2015
• Last updated: August 25, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Gastroparesis
• Hematologic Diseases
• Hematological Disease
• Malignant Disease

Intervention

Other:
• dietary counselling
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).

Locations

Country	Name	City	State
Denmark	Hematological clinic	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of energy and protein	assessed by dietary records from both groups	14 days	No
Secondary	Weightloss change in percent from baseline	calculated by comparing baseline weight with the weight after 14 days	14 days	No
Secondary	Amount of infections	infection, e.g. fever, diarrhoea will be assessed from the medical record	14 days	No
Secondary	Need for tube feeding and parenteral nutrition	will be assessed from the medical record	14 days	No
Secondary	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	No
Secondary	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	No
Secondary	Dose of cytostatics	will be assessed from the medical records	14 days	No
Secondary	unplanned hospital stay	will be assessed from the medical record	14 days	No