MalnutritionDHHNCT01415635
Fortified Hospital Food as Nutritional Support
A study testing Nutritional intervention using in people with Malnutrition, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Background: The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional intervention using
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Feb 2012
- 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
- patients at nutritional risk, according to the NRS-2002 system
- patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
- well-functioning gastrointestinal tract
- anticipated length of hospitalization of more than 3 days
Who cannot join
- terminal patients
- dysphagia
- food allergy or intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
Background:
The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.
Read more
The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.
Methods:
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.
- Conditions
- Malnutrition
- Being tested
- Nutritional intervention using
- Keywords
- Nutritional risk, Hospital food, Nutritional Intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional intervention usingDietary supplement
The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital")(intervention group). Receives: Dietary Supplement: Nutritional intervention using |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement.
Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days
Measured: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
Secondary outcomes (5)
handgrip strength
Handgrip strength (HGS)will be measured with a Jamar Digital Hand Dynanometer. HGS will only be measured in the right hand because the right hand i significantly stronger in right-handed subjects and there is no significant difference between the two sides in left-handed subjects. Subjects will be encouraged to perform maximal contractions three times with a 15-s interval and the average value will be recorded.
Measured: at day 3, 5 and 7
average daily energy and protein intake
Measured: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
Use of tube feeding
Use of tube feeding will be registrated (yes or no and amount (ml.)
Measured: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
use of parenteral nutrition
Registration of use of parenteral nutrition (yes or no). If yes how much (ml.).
Measured: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
length of stay
Measured: an expected average of 9 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tina Munk, MSc., Study director, Herlev University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415635
- Sponsor's protocol ID
- H-1-2011-048
- Acronym
- DHH
- Status last verified
- Dec 2012
- First submitted
- 19 Jul 2011
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen MF, Nielsen MA, Biltz C, Seidelin W, Almdal T. Catering in a large hospital--does serving from a buffet system meet the patients' needs? Clin Nutr. 2008 Aug;27(4):666-9. doi: 10.1016/j.clnu.2008.05.004. Epub 2008 Jul 14.
PubMed 18621450
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01415635
- Acronym / sponsor ID
- DHH / H-1-2011-048
- Conditions
- Malnutrition
- Keywords
- Nutritional risk, Hospital food, Nutritional Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 12 Aug 2011 (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.
Background:
The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.
The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.
Methods:
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Dietary Supplement: Nutritional intervention usingThe study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital")(intervention group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients at nutritional risk, according to the NRS-2002 system
- patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
- well-functioning gastrointestinal tract
- anticipated length of hospitalization of more than 3 days
Key exclusion criteria (3 listed)
- terminal patients
- dysphagia
- food allergy or intolerance
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 |
|---|---|---|
| Nutritional intervention usingThe study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). | Dietary supplement | Nutritional intervention |
Primary outcome
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
Time frame: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement. Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days
5 secondary outcomes
handgrip strength
Time frame: at day 3, 5 and 7
average daily energy and protein intake
Time frame: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
Use of tube feeding
Time frame: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
use of parenteral nutrition
Time frame: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
length of stay
Time frame: an expected average of 9 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Background: PubMed 18621450Hansen MF, Nielsen MA, Biltz C, Seidelin W, Almdal T. Catering in a large hospital--does serving from a buffet system meet the patients' needs? Clin Nutr. 2008 Aug;27(4):666-9. doi: 10.1016/j.clnu.2008.05.004. Epub 2008 Jul 14.
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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.
Tina Munk, MSc. study director
Herlev University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention using in people with Malnutrition, run by Copenhagen University Hospital at Herlev 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 3 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: finished, as of the sponsor's last update on 13 Dec 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements. (time frame: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.). 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 NCT01415635, which also lists 1 linked publication.
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 13 Dec 2012.