MalnutritionNCT01240031
Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
A study testing Individualised nutritional therapy and Usual nutrition care in people with Malnutrition, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Individualised nutritional therapy and Usual nutrition care
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Janice M Sorensen, MSc, (+45) 35 33 32 92, janice@life.ku.dk
About this study
Official title: Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life
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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Individualised nutritional therapy, Usual nutrition care
- Keywords
- Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength, Reaction time, Quality of Life
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised nutritional therapyOther
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.
Usual nutrition careOther
Nutritional therapy according to current practice and general nutrition advice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intake
Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)
Measured: Study period during admission in hopsital
Secondary outcomes (3)
Handgrip strength
Grip track dynamometer (3 trials)
Measured: Study period during admission in hopsital
Reaction time
Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo
Measured: Study period during admission in hopsital
Quality of life
Short Form 36v2 Health Survey (SF36)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, The Danish Dairy Research Foundation, Denmark
- Investigators
- Janice M Sorensen, MSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240031
- Sponsor's protocol ID
- JMS-2010-29293/19069
- Status last verified
- Nov 2010
- First submitted
- 12 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
Publications
Sorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.
Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life
- ClinicalTrials.gov ID
- NCT01240031
- Acronym / sponsor ID
- JMS-2010-29293/19069
- Conditions
- Malnutrition
- Keywords
- Malnutrition, Nutritional Risk, Intake, Food sensory, Nutritional therapy, Energy, Protein, Handgrip strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods, The Danish Dairy Research Foundation, Denmark
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised nutritional therapyNutritional 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. | Other | – |
| Usual nutrition careNutritional therapy according to current practice and general nutrition advice. | Other | – |
Primary outcome
Intake
Time frame: Study period during admission in hopsital
Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)
3 secondary outcomes
Handgrip strength
Time frame: Study period during admission in hopsital
Reaction time
Time frame: Study period during admission in hopsital
Quality of life
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- BackgroundSorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.
- BackgroundSorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice M Sorensen, MSc principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised nutritional therapy and Usual nutrition care in people with Malnutrition, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janice M Sorensen, MSc ((+45) 35 33 32 92, janice@life.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake (time frame: Study period during admission in hopsital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010.