MalnutritionSGGNCT01322087
Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?
A study testing Nutritional intervention in people with Malnutrition, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Rationale: The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to May 2009
- 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 criteria.
- patient must be able to understand the information and be able to give a written inform consent
- well-functioning gastrointestinal tract
- Anticipated length of hospitalization > 5 days
- Should understand and speak danish
Who cannot join
- Terminal patients
- patients with dysphagia
- patient with food allergy or intolerance
- patients who only receives enteral or parenteral nutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Access to Small Delicious Dishes, 24 Hours a Day, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?
Rationale:
The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements.
Methods:
An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.
- Conditions
- Malnutrition
- Being tested
- Nutritional intervention
- Keywords
- Nutrition, new energy dense food concept
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionDietary supplement
The study was a 12 weeks intervention trial with inclusion of 40 patients at nutritional risk, according to the NRS-2002 system.
All included patients received nutritional counseling and information about the new food concept by a clinical dietician.
Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Experimental | Not described Receives: Dietary Supplement: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in energy and protein intake compared to the historical control group
The patient's energy requirement was estimated both from the factorial method and by Harris and Benedicts formula and the protein requirements was taken to be 18 E % of the energy requirement.
Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient. The nutritional registration forms contained information of the energy and protein content of the food
Measured: 3 to 7 days recording of dietary intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Investigators
- Tina Munk, MSc., Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322087
- Sponsor's protocol ID
- H-D-2008-125
- Acronym
- SGG
- Status last verified
- Mar 2011
- First submitted
- 17 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Access to Small Delicious Dishes, 24 Hours a Day, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?
- ClinicalTrials.gov ID
- NCT01322087
- Acronym / sponsor ID
- SGG / H-D-2008-125
- Conditions
- Malnutrition
- Keywords
- Nutrition, new energy dense food concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Mar 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.
Rationale:
The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements.
Methods:
An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Experimental | Dietary Supplement: Nutritional intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients at nutritional risk, according to the NRS-2002 criteria.
- patient must be able to understand the information and be able to give a written inform consent
- well-functioning gastrointestinal tract
- Anticipated length of hospitalization > 5 days
- Should understand and speak danish
Key exclusion criteria (4 listed)
- Terminal patients
- patients with dysphagia
- patient with food allergy or intolerance
- patients who only receives enteral or parenteral nutrition
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 interventionThe study was a 12 weeks intervention trial with inclusion of 40 patients at nutritional risk, according to the NRS-2002 system. All included patients received nutritional counseling and information about the new food concept by a clinical dietician. Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient. | Dietary supplement | Nutritional intervention |
Primary outcome
Change in energy and protein intake compared to the historical control group
Time frame: 3 to 7 days recording of dietary intake
The patient's energy requirement was estimated both from the factorial method and by Harris and Benedicts formula and the protein requirements was taken to be 18 E % of the energy requirement. Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient. The nutritional registration forms contained information of the energy and protein content of the food
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 24 Mar 2011.
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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. principal investigator
Copenhagen University Hospital at Herlev
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 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 5 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: finished, as of the sponsor's last update on 24 Mar 2011. 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?
Change in energy and protein intake compared to the historical control group (time frame: 3 to 7 days recording of dietary intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2011.