MalnutritionMaSuNCT03327935
Post-discharge Nutrition and Resistance Training in Surgical Patients
A study testing Nutrition in people with Malnutrition and Surgery, run by University of Copenhagen at 1 site in Faroe Islands.
Trial summary
Randomized intervention by nutritional supplements and training in postoperative patients after discharge Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Surgery
- What is being tested?
- Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFaroe Islands
- Study dates
- 1 May 2018to 1 Apr 2020
- 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
- Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands
- Aged 18 years or above
- One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery
- At nutritional risk according to screening
Who cannot join
- Minimally invasive surgery/Laparoscopic surgery
- Severely reduced kidney function (p-creatinin>250 mikromol/l) or dialysis
- Terminal illness
- Inability to cooperate in tests or exercises due to cognitive function or dementia
- Admitted to intensive care unit
- Inability to speak or understand Faroese, Danish or English
- Consent according to national regulations not obtainable
Trial locations and contacts
1 site in 1 country.
Faroe Islands1 site
National Hospital of Faroe Islands
Tórshavn, 100
About this study
Official title: Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training
Randomized intervention by nutritional supplements and training in postoperative patients after discharge
Read the detailed description
Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.
- Conditions
- Malnutrition, Surgery
- Being tested
- Nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionDietary supplement
150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass
| Study group | Role | What they receive |
|---|---|---|
| Nutrition | Experimental | Oral nutritional supplements and dietetic advice Receives: Dietary Supplement: Nutrition |
| Nutrition and exercise | Experimental | Oral nutritional supplements, dietetic advice and exercise training Receives: Dietary Supplement: Nutrition |
| Control | No intervention | Standard Hospital Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of lean body mass
Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 May 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of 50 patients each by randomization
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Health Insurance Fund of Research Council Faroe Islands, National Hospital of the Faroe Islands, Société des Produits Nestlé (SPN)
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens Rikardt R Andersen, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327935
- Sponsor's protocol ID
- H-17000004
- Acronym
- MaSu
- Status last verified
- Jul 2020
- First submitted
- 27 Oct 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training
- ClinicalTrials.gov ID
- NCT03327935
- Acronym / sponsor ID
- MaSu / H-17000004
- Conditions
- Malnutrition, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Health Insurance Fund of Research Council Faroe Islands, National Hospital of the Faroe Islands, Société des Produits Nestlé (SPN)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 1 Nov 2017 (actual)
- 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.
Randomized intervention by nutritional supplements and training in postoperative patients after discharge
Detailed description
Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups of 50 patients each by randomization
| Arm | Type | Receives |
|---|---|---|
| Nutrition | Experimental | Dietary Supplement: NutritionOral nutritional supplements and dietetic advice |
| Nutrition and exercise | Experimental | Dietary Supplement: NutritionOral nutritional supplements, dietetic advice and exercise training |
| Control | No intervention | –Standard Hospital Procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands
- Aged 18 years or above
- One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery
- At nutritional risk according to screening
Key exclusion criteria (7 listed)
- Minimally invasive surgery/Laparoscopic surgery
- Severely reduced kidney function (p-creatinin>250 mikromol/l) or dialysis
- Terminal illness
- Inability to cooperate in tests or exercises due to cognitive function or dementia
- Admitted to intensive care unit
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 |
|---|---|---|
| Nutrition150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass | Dietary supplement | Nutrition, Nutrition and exercise |
Primary outcome
Loss of lean body mass
Time frame: 8 weeks
Non-bone lean mass measured by dual energy x-ray absorptiometry (DXA) whole-body scans
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Jens Rikardt R Andersen study chair
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 Nutrition in people with Malnutrition and Surgery, run by University of Copenhagen at 1 site in Faroe Islands.
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 7 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 23 Jul 2020. 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 Faroe Islands. 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?
Loss of lean body mass (time frame: 8 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 23 Jul 2020.