MalnutritionPhase 4NCT00417508
Nutritional Intervention in Malnourished Elderly Patients
A Phase 4 study testing Sip feeding and Dietary Advice in people with Malnutrition, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Sip feeding and Dietary Advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2006to May 2012
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Body Mass Index < 20 kg/m2
- Medical In/Outpatient or District Nurse-patient
- Able to take nutritional supplement (sip feeding)
- Able to walk
- Written patient informed consent
Who cannot join
- Actual malignancy
- Dementia with a Mini Mental Status score < 24
- Severe depression
- Need for Total Parenteral Nutrition or Tube Feeding
- Prescribed nutritional supplements during more than the last week
- Life expectancy of less than 6 months
Trial locations and contacts
1 site in 1 country.
Norway1 site
University Hospital of Northern Norway, Dep of Medical Gastroenterology
Tromsø, Tromsoe, 9038
About this study
Official title: Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
Read the detailed description
Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index < 20 kg/m2 are asked to participate.
Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.
Primary and secondary outcome parameters are measured at inclusion and week 12
- Conditions
- Malnutrition
- Being tested
- Sip feeding, Dietary Advice
- Keywords
- function, elderly, ADL, nutritional supplementation, Quality of life, handgrip strength, Body Composition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sip feedingDietary supplement
Also called Fresubin Protein Energy Drink
Daily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal)
Dietary AdviceDietary supplement
The patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional supplement | Experimental | 2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein Receives: Dietary Supplement: Sip feeding |
| Dietary advice | Active comparator | ordinary dietary advice with a recommendation of four meals per day or similar dietary advice Receives: Dietary Supplement: Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Health (Short form 36)
Measured: Start and 12 weeks
Secondary outcomes (6)
Nutritional Measures (at inclusion and week 12)
Measured: Start and 12 weeks
Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
Measured: at 6 and 12 weeks
Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
Measured: Start and 12 weeks
Observed ADL
Barthels index
Measured: Start and at 12 weeks
Timed Up and Go test
Measured: Start and12 weeks
Hand grip strength
Measured: Start and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: It was not possible to recruite sufficient number of participants
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Research in the Elderly, Tromsoe, Norway
- Responsible party
- Sponsor
- Investigators
- Jon R Florholmen, MD, PhD, Study chair, University Hospital of Northern Norway, Dep of Medical Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417508
- Sponsor's protocol ID
- P REK NORD 64/2003
- Status last verified
- Jun 2012
- First submitted
- 29 Dec 2006
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nutritional Intervention in Malnourished Elderly Patients
- ClinicalTrials.gov ID
- NCT00417508
- Acronym / sponsor ID
- P REK NORD 64/2003
- Conditions
- Malnutrition
- Keywords
- function, elderly, ADL, nutritional supplementation, Quality of life, handgrip strength, Body Composition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was not possible to recruite sufficient number of participants
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Centre for Research in the Elderly, Tromsoe, Norway
- Study start
- Dec 2006
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Jan 2007 (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 investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.
Detailed description
Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index < 20 kg/m2 are asked to participate.
Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.
Primary and secondary outcome parameters are measured at inclusion and week 12
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional supplement | Experimental | Dietary Supplement: Sip feeding2 packages/day with nutritional supplement containing a total of 600 kcal and 40 g protein |
| Dietary advice | Active comparator | Dietary Supplement: Dietary Adviceordinary dietary advice with a recommendation of four meals per day or similar dietary advice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Body Mass Index < 20 kg/m2
- Medical In/Outpatient or District Nurse-patient
- Able to take nutritional supplement (sip feeding)
- Able to walk
- Written patient informed consent
Key exclusion criteria (6 listed)
- Actual malignancy
- Dementia with a Mini Mental Status score < 24
- Severe depression
- Need for Total Parenteral Nutrition or Tube Feeding
- Prescribed nutritional supplements during more than the last week
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 |
|---|---|---|
| Sip feedingAlso: Fresubin Protein Energy DrinkDaily supplement with sip feeding, 2 packages(each package containing 200 ml,20 g protein and 300 kcal) | Dietary supplement | Nutritional supplement |
| Dietary AdviceThe patients will receive ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and no daily sip feeding supplements. | Dietary supplement | Dietary advice |
Primary outcome
Functional Health (Short form 36)
Time frame: Start and 12 weeks
6 secondary outcomes
Nutritional Measures (at inclusion and week 12)
Time frame: Start and 12 weeks
Change in Body weight and Lean Body Mass(evaluated with dual energy X-ray absorptiometry)
Time frame: at 6 and 12 weeks
Psychological Measures (at inclusion and week 12) Hospital Anxiety and Depression scale
Time frame: Start and 12 weeks
Observed ADL
Time frame: Start and at 12 weeks
Timed Up and Go test
Time frame: Start and12 weeks
Hand grip strength
Time frame: Start and 12 weeks
Results and safety
The study was stopped early (reason given: It was not possible to recruite sufficient number of participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
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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.
Jon R Florholmen, MD, PhD study chair
University Hospital of Northern Norway, Dep of Medical Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sip feeding and Dietary Advice in people with Malnutrition, run by University Hospital of North Norway at 1 site in Norway.
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 6 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: stopped early, as of the sponsor's last update on 18 Apr 2019. 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 Norway. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was not possible to recruite sufficient number of participants). Results are not available in the source record.
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?
Functional Health (Short form 36) (time frame: Start and 12 weeks). 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 18 Apr 2019.