MalnutritionPhase 4EFFORTNCT02517476
Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial
A Phase 4 study testing Nutritional therapy in people with Malnutrition, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutritional therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,088 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to 16 May 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- NRS ≥3 points
- expected hospital LOS ≥5 days (as estimated by the treating physician team)
- willingness to provide informed consent (see informed consent statement)
Who cannot join
- initially admitted to critical care units (except intermediate care)
- scheduled for surgery or in an immediate post-operative state
- unable to ingest oral nutrition and thus need for enteral or parenteral nutrition
- admitted with, or scheduled for, total parenteral nutrition or tube feeding
- currently under nutritional therapy (defined by at least one visit with a dietician in the last month)
- who are hospitalized because of anorexia nervosa
Show all 14Show fewer
- in terminal condition (end of life situation)
- hospitalized due to acute pancreatitis
- hospitalized due to acute liver failure
- earlier inclusion into this trial
- cystic fibrosis
- patients after gastric bypass operations
- stem cell transplantation
- any contraindication against nutritional therapy (i.e., enteral and/or parenteral)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Clinic, Kantonsspital Aarau
Aarau, Canton of Aargau, 5000
About this study
Official title: Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial: The EFFORT Trial
The aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works.
Read the detailed description
The aims of the randomized-controlled, multicenter EFFORT trial are to test the hypothesis that in medical inpatients at risk for undernutrition defined by the nutritional risk score (NRS 2002), early tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a cost-effective strategy to prevent mortality, morbidity and functional decline.
The primary composite endpoint is combined adverse outcome within 30 days defined as (a) all-cause mortality, (b) admission to the intensive care unit from the medical ward, (c) major complications, (d) unplanned hospital readmissions and (d) decline in functional outcome from admission to day 30 assessed by Barthel's index (-10%). Secondary endpoints include (a) each single component of the primary endpoint (b) short-term nutritional and functional outcomes from inclusion to day 10 or hospital discharge; (c) hospital outcomes; (d) 30-day and 180-day outcomes (e) Other safety endpoints including adverse gastrointestinal effects associated with nutritional therapy assessed daily until hospital discharge.
The investigators will include unselected adult medical inpatients at risk of undernutrition [NRS≥3 points] and an expected hospital stay of ≥5 days who are willing to provide informed consent. The investigators will exclude patients in critical care or post-operative state, unable to swallow, at long-term need for parenteral/enteral nutrition, in terminal condition, pregnant, with acute pancreatitis or acute liver failure, with anorexia nervosa, that were earlier included into the trial Patients in the intervention group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, micronutrients, other) based on a predefined nutritional strategy. In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated every 24-48 hours (food fortification, oral supplements, enteral, parenteral nutrition) if targets are not met (at least 75% of targets).
The targeted sample size is 2000 - 3000 patients. The inclusion of 2000 - 3000 patients will provide between 76% and 91% power to detect a reduction in the primary endpoint of 15% (from 40% to 34%) assuming a lost to follow up rate of 10%.
- Conditions
- Malnutrition
- Being tested
- Nutritional therapy
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional therapyDietary supplement
Any nutritional product and route (i.e. food fortification, oral, enteral, parenteral) is possible to reach goals
| Study group | Role | What they receive |
|---|---|---|
| Nutritional support | Experimental | For the purpose of this study, we have developed nutritional guidelines by consensus and adapted to current guidelines (e.g., ESPEN, ASPEN). These guidelines specify a reinforced nutritional therapy strategy to cover nutritional requirements, focusing on nutritional targets based on the specific nutritional diagnoses defined by the IDNT. The nutritional guidelines may vary according to important medical diagnoses (i.e. renal failure). They specify not only nutritional targets, but also escalation of the route (i.e. food fortification, oral, enteral, parenteral) if targets cannot be achieved (≤75%) every 5 hours. Nutritional goals are being assessed daily in patients in the intervention group. Receives: Dietary Supplement: Nutritional therapy |
| Usual care ("appetite-guided") controls | No intervention | In control patients, we will use conventional nutrition according to the ability and desire of the patient to eat, using standard care food provided by the hospital kitchen ("appetite-guided"). |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary composite endpoint
Number of participants with adverse events including
- All-cause mortality
- Admission to the intensive care unit
- Unplanned hospital readmission after hospital discharge
- Major complications including nosocomial infection or abscess requiring antibiotic treatment, respiratory failure with need for invasive or non-invasive ventilation, major cardiovascular event or pulmonary embolism, acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis), gastro-intestinal hemorrhage or intestinal perforation assessed by medical chart review and telephone interview
- decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index assessed by patient interview on admission and after 30 days
Measured: measured at day 30 by telephone interview
Secondary outcomes (6)
Weight change
change in weight and BMI from inclusion to day 30 by patient interview and medical chart review
Measured: measured at day 30 by telephone interview
lenght of hospital stay
days in the hospital within index hospitalisation and within the 30 days of follow up measured by patient interview and medical chart review
Measured: participants will be followed for the duration of hospital stay with an expected average of 10 days
Improvement in quality of life
Improvement in quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire on admission and during follow up measured by patient interview
Measured: measured at days 30 and 180 by telephone interview
Combined safety endpoints in regard to side effects from nutritional therapy
Number of participants with side effects from nutritional therapy including
(a) adverse gastrointestinal effects (diarrhea, nausea, vomiting, abdominal pain) assessed by patient interview (yes/no) b) Complications due to tube feeding or center catheter for parenteral nutrition assessed by medical chart review (c) Refeeding syndrome assessed by chart review (d) Acute pancreatitis defined as 2 out of 3 criteria: abdominal pain, 3-fold increase in lipase or amylase, characteristic imaging findings assessed by chart review (e) Liver or gall bladder dysfunction assessed by chart review (f) Hyperglycemia (defined as glucose levels >12mmol/l or persistent levels >10mmol/l in patients without diabetes or well controlled diabetes) assessed by medical chart review
Measured: measured at day 30
new decubital ulcer
Clinical diagnosis of decubital ulcer with onset after study inclusion measured by patient interview and medical chart review
Measured: assessed on the day of hospital discharge after an expected average of 10 days
Discharge location
proportion discharge home or to a rehab facility measured by patient interview and medical chart review
Measured: assessed on the day of hospital discharge after an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2014
- Primary completion15 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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 Hospital, Basel, SwitzerlandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,088 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern, Luzerner Kantonsspital, Kantonsspital Münsterlingen, Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Principal investigator, Philipp Schuetz, University Hospital, Basel, Switzerland
- Investigators
- Philipp Schuetz, Prof. Dr., Principal investigator, University Clinic, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517476
- Sponsor's protocol ID
- EKNZ 2014-001
- Acronym
- EFFORT
- Status last verified
- May 2018
- First submitted
- 30 Jul 2015
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Schuetz P. "Eat your lunch!" - controversies in the nutrition of the acutely, non-critically ill medical inpatient. Swiss Med Wkly. 2015 Apr 23;145:w14132. doi: 10.4414/smw.2015.14132. eCollection 2015.
PubMed 25906253Schutz P, Bally M, Stanga Z, Keller U. Loss of appetite in acutely ill medical inpatients: physiological response or therapeutic target? Swiss Med Wkly. 2014 Apr 29;144:w13957. doi: 10.4414/smw.2014.13957. eCollection 2014.
PubMed 24782139Stern A, Wunderle C, Tribolet P, Neyer PJ, Bernasconi L, Stanga Z, Mueller B, Schuetz P. Trimethylamine N-oxide (TMAO) as a prognostic marker among patients at nutritional risk. A secondary analysis of the randomized clinical trial EFFORT. Eur J Clin Nutr. 2026 Jul;80(7):700-707. doi: 10.1038/s41430-026-01750-1. Epub 2026 Apr 18.
PubMed 42000912Wunderle C, Martin E, Wittig A, Tribolet P, Lutz TA, Koster-Hegmann C, Stanga Z, Mueller B, Schuetz P. Comparison of the inflammatory biomarkers IL- 6, TNF-alpha, and CRP to predict the effect of nutritional therapy on mortality in medical patients at risk of malnutrition : A secondary analysis of the randomized clinical trial EFFORT. J Inflamm (Lond). 2025 Apr 24;22(1):16. doi: 10.1186/s12950-025-00442-0.
PubMed 40275239Tribolet P, Wunderle C, Kaegi-Braun N, Buchmueller L, Laager R, Stanga Z, Mueller B, Wagner KH, Schuetz P. Evaluating repeated handgrip strength measurements as predictors of mortality in malnourished hospitalized patients. Secondary analysis of a randomized controlled trial. Eur J Clin Nutr. 2025 Sep;79(9):897-903. doi: 10.1038/s41430-025-01618-w. Epub 2025 Apr 16.
PubMed 40240521Diethelm J, Wunderle C, van Zanten ARH, Tribolet P, Stanga Z, Mueller B, Schuetz P. Urea-to-creatinine ratio as a biomarker for clinical outcome and response to nutritional support in non-critically ill patients: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2025 Jun;67:242-249. doi: 10.1016/j.clnesp.2025.03.042. Epub 2025 Mar 21.
PubMed 40122337Randegger S, Wunderle C, Johansen OE, Tribolet P, Pavlicek V, Braendle M, Henzen C, Thomann R, Neyer P, Stanga Z, Mueller B, Schuetz P. Low plasma pancreatic lipase as a novel predictor of nutritional target achievement and response to nutritional interventions in malnourished inpatients: Secondary analysis of a randomized clinical trial. Clin Nutr. 2025 Apr;47:196-203. doi: 10.1016/j.clnu.2025.02.029. Epub 2025 Feb 25.
PubMed 40037114Buchmueller LC, Wunderle C, Laager R, Bernasconi L, Neyer PJ, Tribolet P, Stanga Z, Mueller B, Schuetz P. Association of phenylalanine and tyrosine metabolism with mortality and response to nutritional support among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Front Nutr. 2024 Nov 12;11:1451081. doi: 10.3389/fnut.2024.1451081. eCollection 2024.
PubMed 39600719Wunderle C, Suter SS, Endner N, Haenggi E, Kaegi-Braun N, Tribolet P, Stanga Z, Mueller B, Schuetz P. Sex differences in clinical presentation, treatment response, and side effects of nutritional therapy among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Am J Clin Nutr. 2024 Nov;120(5):1225-1232. doi: 10.1016/j.ajcnut.2024.09.020. Epub 2024 Sep 21.
PubMed 39307186Wunderle C, Ciobanu C, Ritz J, Tribolet P, Neyer P, Bernasconi L, Stanga Z, Mueller B, Schuetz P. Association of leucine and other branched chain amino acids with clinical outcomes in malnourished inpatients: a secondary analysis of the randomized clinical trial EFFORT. Eur J Clin Nutr. 2025 Jan;79(1):42-49. doi: 10.1038/s41430-024-01507-8. Epub 2024 Sep 8.
PubMed 39245679Olpe T, Wunderle C, Bargetzi L, Tribolet P, Laviano A, Stanga Z, Prado CM, Mueller B, Schuetz P. Muscle matters: Prognostic implications of malnutrition and muscle health parameters in patients with cancer. A secondary analysis of a randomised trial. Clin Nutr. 2024 Sep;43(9):2255-2262. doi: 10.1016/j.clnu.2024.07.020. Epub 2024 Aug 2.
PubMed 39181036Keller B, Wunderle C, Tribolet P, Stanga Z, Kaegi-Braun N, Mueller B, Schuetz P. Nutritional support in hospitalised patients with diabetes and risk for malnutrition: a secondary analysis of an investigator-initiated, Swiss, randomised controlled multicentre trial. BMJ Open. 2024 Aug 17;14(8):e084754. doi: 10.1136/bmjopen-2024-084754.
PubMed 39153787Stumpf F, Wunderle C, Ritz J, Bernasconi L, Neyer P, Tribolet P, Stanga Z, Mueller B, Bischoff SC, Schuetz P. Prognostic implications of the arginine metabolism in patients at nutritional risk: A secondary analysis of the randomized EFFORT trial. Clin Nutr. 2024 Mar;43(3):660-673. doi: 10.1016/j.clnu.2024.01.012. Epub 2024 Jan 22.
PubMed 38309228Wunderle C, Siegenthaler J, Seres D, Owen-Michaane M, Tribolet P, Stanga Z, Mueller B, Schuetz P. Adaptation of nutritional risk screening tools may better predict response to nutritional treatment: a secondary analysis of the randomized controlled trial Effect of early nutritional therapy on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT). Am J Clin Nutr. 2024 Mar;119(3):800-808. doi: 10.1016/j.ajcnut.2024.01.013. Epub 2024 Jan 28.
PubMed 38290574Haenggi E, Kaegi-Braun N, Wunderle C, Tribolet P, Mueller B, Stanga Z, Schuetz P. Red blood cell distribution width (RDW) - A new nutritional biomarker to assess nutritional risk and response to nutritional therapy? Clin Nutr. 2024 Feb;43(2):575-585. doi: 10.1016/j.clnu.2024.01.001. Epub 2024 Jan 5.
PubMed 38242035
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Nutritional Therapy on Frailty, Functional Outcomes and Recovery of Undernourished Medical Inpatients Trial: The EFFORT Trial
- ClinicalTrials.gov ID
- NCT02517476
- Acronym / sponsor ID
- EFFORT / EKNZ 2014-001
- Conditions
- Malnutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,088 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Insel Gruppe AG, University Hospital Bern, Luzerner Kantonsspital, Kantonsspital Münsterlingen, Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- Apr 2014 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 7 Aug 2015 (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 aims of the randomized-controlled, multicenter EFFORT trial are to assess the effects of early nutritional therapy in regard to effectiveness, safety and costs when applied to the heterogenous, polymorbid medical inpatient population. EFFORT will not only answer the question about overall benefit or harm, but using a physio-pathological mechanistic approach, it also will explore and provide conclusive answers about whether, why, how, and in which patient populations nutritional therapy does and does not works.
Detailed description
The aims of the randomized-controlled, multicenter EFFORT trial are to test the hypothesis that in medical inpatients at risk for undernutrition defined by the nutritional risk score (NRS 2002), early tailored nutritional therapy to reach nutritional targets based on individualized nutritional counseling is a cost-effective strategy to prevent mortality, morbidity and functional decline.
The primary composite endpoint is combined adverse outcome within 30 days defined as (a) all-cause mortality, (b) admission to the intensive care unit from the medical ward, (c) major complications, (d) unplanned hospital readmissions and (d) decline in functional outcome from admission to day 30 assessed by Barthel's index (-10%). Secondary endpoints include (a) each single component of the primary endpoint (b) short-term nutritional and functional outcomes from inclusion to day 10 or hospital discharge; (c) hospital outcomes; (d) 30-day and 180-day outcomes (e) Other safety endpoints including adverse gastrointestinal effects associated with nutritional therapy assessed daily until hospital discharge.
The investigators will include unselected adult medical inpatients at risk of undernutrition [NRS≥3 points] and an expected hospital stay of ≥5 days who are willing to provide informed consent. The investigators will exclude patients in critical care or post-operative state, unable to swallow, at long-term need for parenteral/enteral nutrition, in terminal condition, pregnant, with acute pancreatitis or acute liver failure, with anorexia nervosa, that were earlier included into the trial Patients in the intervention group will receive individualized nutritional therapy to reach nutritional targets (caloric, protein, micronutrients, other) based on a predefined nutritional strategy. In control patients, according to patients' appetite, standard hospital nutrition will be served. Nutritional therapy may be started in control patients, if any sort of swallowing disorders develops or if patients need to be prepared for operation. All patients will be re-assessed daily during the hospital stay for nutritional intake and nutritional therapy may be escalated every 24-48 hours (food fortification, oral supplements, enteral, parenteral nutrition) if targets are not met (at least 75% of targets).
The targeted sample size is 2000 - 3000 patients. The inclusion of 2000 - 3000 patients will provide between 76% and 91% power to detect a reduction in the primary endpoint of 15% (from 40% to 34%) assuming a lost to follow up rate of 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional support | Experimental | Dietary Supplement: Nutritional therapyFor the purpose of this study, we have developed nutritional guidelines by consensus and adapted to current guidelines (e.g., ESPEN, ASPEN). These guidelines specify a reinforced nutritional therapy strategy to cover nutritional requirements, focusing on nutritional targets based on the specific nutritional diagnoses defined by the IDNT. The nutritional guidelines may vary according to important medical diagnoses (i.e. renal failure). They specify not only nutritional targets, but also escalation of the route (i.e. food fortification, oral, enteral, parenteral) if targets cannot be achieved (≤75%) every 5 hours. Nutritional goals are being assessed daily in patients in the intervention group. |
| Usual care ("appetite-guided") controls | No intervention | –In control patients, we will use conventional nutrition according to the ability and desire of the patient to eat, using standard care food provided by the hospital kitchen ("appetite-guided"). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- NRS ≥3 points
- expected hospital LOS ≥5 days (as estimated by the treating physician team)
- willingness to provide informed consent (see informed consent statement)
Key exclusion criteria (14 listed)
- initially admitted to critical care units (except intermediate care)
- scheduled for surgery or in an immediate post-operative state
- unable to ingest oral nutrition and thus need for enteral or parenteral nutrition
- admitted with, or scheduled for, total parenteral nutrition or tube feeding
- currently under nutritional therapy (defined by at least one visit with a dietician in the last month)
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 therapyAny nutritional product and route (i.e. food fortification, oral, enteral, parenteral) is possible to reach goals | Dietary supplement | Nutritional support |
Primary outcome
primary composite endpoint
Time frame: measured at day 30 by telephone interview
Number of participants with adverse events including 1. All-cause mortality 2. Admission to the intensive care unit 3. Unplanned hospital readmission after hospital discharge 4. Major complications including nosocomial infection or abscess requiring antibiotic treatment, respiratory failure with need for invasive or non-invasive ventilation, major cardiovascular event or pulmonary embolism, acute renal failure (defined by 2x increase of baseline creatinine or new requirement of dialysis), gastro-intestinal hemorrhage or intestinal perforation assessed by medical chart review and telephone interview 5. decline in functional status of 10% or more from admission to day 30 measured by the Barthel's index assessed by patient interview on admission and after 30 days
6 secondary outcomes
Weight change
Time frame: measured at day 30 by telephone interview
lenght of hospital stay
Time frame: participants will be followed for the duration of hospital stay with an expected average of 10 days
Improvement in quality of life
Time frame: measured at days 30 and 180 by telephone interview
Combined safety endpoints in regard to side effects from nutritional therapy
Time frame: measured at day 30
new decubital ulcer
Time frame: assessed on the day of hospital discharge after an expected average of 10 days
Discharge location
Time frame: assessed on the day of hospital discharge after an expected average of 10 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 18 May 2018.
- Background: PubMed 25906253Schuetz P. "Eat your lunch!" - controversies in the nutrition of the acutely, non-critically ill medical inpatient. Swiss Med Wkly. 2015 Apr 23;145:w14132. doi: 10.4414/smw.2015.14132. eCollection 2015.
- Background: PubMed 24782139Schutz P, Bally M, Stanga Z, Keller U. Loss of appetite in acutely ill medical inpatients: physiological response or therapeutic target? Swiss Med Wkly. 2014 Apr 29;144:w13957. doi: 10.4414/smw.2014.13957. eCollection 2014.
- Derived from this study: PubMed 42000912Stern A, Wunderle C, Tribolet P, Neyer PJ, Bernasconi L, Stanga Z, Mueller B, Schuetz P. Trimethylamine N-oxide (TMAO) as a prognostic marker among patients at nutritional risk. A secondary analysis of the randomized clinical trial EFFORT. Eur J Clin Nutr. 2026 Jul;80(7):700-707. doi: 10.1038/s41430-026-01750-1. Epub 2026 Apr 18.
- Derived from this study: PubMed 40275239Wunderle C, Martin E, Wittig A, Tribolet P, Lutz TA, Koster-Hegmann C, Stanga Z, Mueller B, Schuetz P. Comparison of the inflammatory biomarkers IL- 6, TNF-alpha, and CRP to predict the effect of nutritional therapy on mortality in medical patients at risk of malnutrition : A secondary analysis of the randomized clinical trial EFFORT. J Inflamm (Lond). 2025 Apr 24;22(1):16. doi: 10.1186/s12950-025-00442-0.
- Derived from this study: PubMed 40240521Tribolet P, Wunderle C, Kaegi-Braun N, Buchmueller L, Laager R, Stanga Z, Mueller B, Wagner KH, Schuetz P. Evaluating repeated handgrip strength measurements as predictors of mortality in malnourished hospitalized patients. Secondary analysis of a randomized controlled trial. Eur J Clin Nutr. 2025 Sep;79(9):897-903. doi: 10.1038/s41430-025-01618-w. Epub 2025 Apr 16.
- Derived from this study: PubMed 40122337Diethelm J, Wunderle C, van Zanten ARH, Tribolet P, Stanga Z, Mueller B, Schuetz P. Urea-to-creatinine ratio as a biomarker for clinical outcome and response to nutritional support in non-critically ill patients: A secondary analysis of a randomized controlled trial. Clin Nutr ESPEN. 2025 Jun;67:242-249. doi: 10.1016/j.clnesp.2025.03.042. Epub 2025 Mar 21.
- Derived from this study: PubMed 40037114Randegger S, Wunderle C, Johansen OE, Tribolet P, Pavlicek V, Braendle M, Henzen C, Thomann R, Neyer P, Stanga Z, Mueller B, Schuetz P. Low plasma pancreatic lipase as a novel predictor of nutritional target achievement and response to nutritional interventions in malnourished inpatients: Secondary analysis of a randomized clinical trial. Clin Nutr. 2025 Apr;47:196-203. doi: 10.1016/j.clnu.2025.02.029. Epub 2025 Feb 25.
- Derived from this study: PubMed 39600719Buchmueller LC, Wunderle C, Laager R, Bernasconi L, Neyer PJ, Tribolet P, Stanga Z, Mueller B, Schuetz P. Association of phenylalanine and tyrosine metabolism with mortality and response to nutritional support among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Front Nutr. 2024 Nov 12;11:1451081. doi: 10.3389/fnut.2024.1451081. eCollection 2024.
- Derived from this study: PubMed 39307186Wunderle C, Suter SS, Endner N, Haenggi E, Kaegi-Braun N, Tribolet P, Stanga Z, Mueller B, Schuetz P. Sex differences in clinical presentation, treatment response, and side effects of nutritional therapy among patients at nutritional risk: a secondary analysis of the randomized clinical trial EFFORT. Am J Clin Nutr. 2024 Nov;120(5):1225-1232. doi: 10.1016/j.ajcnut.2024.09.020. Epub 2024 Sep 21.
- Derived from this study: PubMed 39245679Wunderle C, Ciobanu C, Ritz J, Tribolet P, Neyer P, Bernasconi L, Stanga Z, Mueller B, Schuetz P. Association of leucine and other branched chain amino acids with clinical outcomes in malnourished inpatients: a secondary analysis of the randomized clinical trial EFFORT. Eur J Clin Nutr. 2025 Jan;79(1):42-49. doi: 10.1038/s41430-024-01507-8. Epub 2024 Sep 8.
- Derived from this study: PubMed 39181036Olpe T, Wunderle C, Bargetzi L, Tribolet P, Laviano A, Stanga Z, Prado CM, Mueller B, Schuetz P. Muscle matters: Prognostic implications of malnutrition and muscle health parameters in patients with cancer. A secondary analysis of a randomised trial. Clin Nutr. 2024 Sep;43(9):2255-2262. doi: 10.1016/j.clnu.2024.07.020. Epub 2024 Aug 2.
- Derived from this study: PubMed 39153787Keller B, Wunderle C, Tribolet P, Stanga Z, Kaegi-Braun N, Mueller B, Schuetz P. Nutritional support in hospitalised patients with diabetes and risk for malnutrition: a secondary analysis of an investigator-initiated, Swiss, randomised controlled multicentre trial. BMJ Open. 2024 Aug 17;14(8):e084754. doi: 10.1136/bmjopen-2024-084754.
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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.
Philipp Schuetz, Prof. Dr. principal investigator
University Clinic, Kantonsspital Aarau
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 Nutritional therapy in people with Malnutrition, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 14 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 18 May 2018. 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 Switzerland. 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 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?
primary composite endpoint (time frame: measured at day 30 by telephone interview). 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 NCT02517476, which also lists 31 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 18 May 2018.