Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
Primary Purpose
Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Individualised nutritional therapy
Usual nutrition care
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition focused on measuring Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength, Reaction time, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Nutritional risk as per Nutrition Risk Screening 2002 (NRS-2002)
- Hospital admited at Rigshospitalets (various medical departments)
- Expect length of stay >= 5 days
- Informed consent to participate
Exclusion Criteria:
- Dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials.
- Inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition.
- Enteral or parenteral nutrition as primary nutritional therapy.
- Previous participation in the study.
Sites / Locations
- RigshospitaletRecruiting
Outcomes
Primary Outcome Measures
Intake
Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)
Secondary Outcome Measures
Handgrip strength
Grip track dynamometer (3 trials)
Reaction time
Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo
Quality of life
Short Form 36v2 Health Survey (SF36)
Full Information
NCT ID
NCT01240031
First Posted
November 12, 2010
Last Updated
November 12, 2010
Sponsor
University of Copenhagen
Collaborators
Arla Foods, The Danish Dairy Research Foundation, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT01240031
Brief Title
Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
Official Title
Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Arla Foods, The Danish Dairy Research Foundation, Denmark
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether individualised nutritional therapy comprised of appetising, energy- and protein-rich foods can have a positive effect on physiological function and quality of life of undernourished patients as compared to usual nutrition care.
Detailed Description
Undernutrition and insufficent dietary intake in hospitalised patients is a widespread problem. It is associated with increased morbidity and mortality, worsened physiological function and quality of life and increased expenses for the health care system. Food quality has been shown to be positively associated with dietary intake in patients. However, there has lacked knowledge on how food quality can be optimised to promote intake. A project was therefore initiated, which aimed at establishing a framework for developing appetising, energy- and protein-rich foods for patients at nutritional risk. This project included qualitative and quantitative investigation of nutritional risk patients' meal experiences and preferences (se citations below). These results have served as a basis for optimsing energy- and protein-rich foods as part of an indivudalised nutritional therapy aimed at improving dietary intake in nutritional risk patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength, Reaction time, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Individualised nutritional therapy
Intervention Description
Nutritional therapy as based on previous results of the project on patient meal experiences and preferences (note citations below) and comprising of:
Thorough sensory and nutrition assessment (questionnaire).
Nutrition plan adjusted daily according to the assessment.
Serving appetising, energy- and protein-dense meals, snacks and drinks.
Intervention Type
Other
Intervention Name(s)
Usual nutrition care
Intervention Description
Nutritional therapy according to current practice and general nutrition advice.
Primary Outcome Measure Information:
Title
Intake
Description
Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)
Time Frame
Study period during admission in hopsital
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Grip track dynamometer (3 trials)
Time Frame
Study period during admission in hopsital
Title
Reaction time
Description
Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo
Time Frame
Study period during admission in hopsital
Title
Quality of life
Description
Short Form 36v2 Health Survey (SF36)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nutritional risk as per Nutrition Risk Screening 2002 (NRS-2002)
Hospital admited at Rigshospitalets (various medical departments)
Expect length of stay >= 5 days
Informed consent to participate
Exclusion Criteria:
Dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials.
Inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition.
Enteral or parenteral nutrition as primary nutritional therapy.
Previous participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janice M Sorensen, MSc
Phone
(+45) 35 33 32 92
Email
janice@life.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice M Sorensen, MSc
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice M Sorensen, MSc
Phone
(+45) 35 33 32 92
Email
janice@life.ku.dk
12. IPD Sharing Statement
Citations:
Citation
Sorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.
Results Reference
background
Citation
Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.
Results Reference
background
Learn more about this trial
Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
We'll reach out to this number within 24 hrs