SarcopeniaNCT05096013
Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation
A study testing individual nutritional therapy in people with Sarcopenia and Malnutrition, run by Thimo Marcin at 1 site in Switzerland.
Trial summary
Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcopenia, Malnutrition
- What is being tested?
- individual nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2021to 14 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia
- light to moderate risk of malnutrition (Nutritional Risk Score-2002: 3-4 Points)
- risk of sarcopenia (sarc-f >=4)
- signed informed consent
Who cannot join
- medically described nutritional support
- reasons (cognitive, language) that prevent a informed consent
- enteral or parenteral nutrition
- after bariatric surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Berner Reha Zentrum
Heiligenschwendi, Canton of Bern, 3625
About this study
Official title: Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial
Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses.
This study investigates the efficacy of individualized nutrition therapy (iNT) in pulmonary rehabilitation. Patients at significant risk for malnutrition already receive iNT within clinical routine during rehabilitation. The investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from iNT.
Read the detailed description
The participating patients are randomly assigned to two groups after giving written consent.
The intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. The iNT determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. Measures may include, for example, adjustments to the meal plan or nutritional supplementation. The measures are continuously adapted to the patients' needs.
The control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. However, patients from the control group do not receive additional counseling or adjustment by the iNT.
Patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. Average duration of rehabilitation is expected to be three weeks. As primary outcome, change in energy intake will be compared between groups. Additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.
- Conditions
- Sarcopenia, Malnutrition
- Being tested
- individual nutritional therapy
- Keywords
- individual nutrition therapy
- Medical subject headings
- Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual nutritional therapyOther
Intervention arm: Usual care + individualized nutritional therapy. Patients at risk for malnutrition and sarcopenia will receive a counselling by the nutritional therapist twice a week. The therapists will assess the patient's energy and protein demand in order to develope appropriate individual measures (e.g additional meals or supplements) to increase patients' energy and protein intake. Individual nutritional therapy is already usual care in patients with high risk for malnutrition, but not for patients with only light to moderate risk of malnutrition and risk of sarcopenia.
| Study group | Role | What they receive |
|---|---|---|
| individual nutrition therapy | Experimental | Individualized nutrition therapy: Specialists in nutritional counseling determine the patient's individual energy and protein needs and create targeted individual measures to achieve them. Measures can include, for example, adjustments to the menu, food enrichment or supplementation. The measures are discussed with the patients on an ongoing basis and adjusted as necessary. Receives: Other: individual nutritional therapy |
| usual care | No intervention | Usual care: Participants in the control group receive a standardized food fortification of the soups with fat and protein, as well as an energy- and protein-rich dessert. No additional advice or adjustments are made by the iNT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Change in energy intake [kcal] from start to end of rehabilitation.
Measured: From admission to discharge (2-3 weeks)
Secondary outcomes (4)
protein intake
Change in protein intake [g] from start to end of rehabilitation.
Measured: From admission to discharge (2-3 weeks)
grip strength
Change in grip strength (muscle strength) from start to end of rehabilitation.
Measured: From admission to discharge (2-3 weeks)
lean body mass
Change in lean body mass (muscle mass) from start to end of rehabilitation.
Measured: From admission to discharge (2-3 weeks)
time up and go
Change in time up an go time (muscle function) from start to end of rehabilitation
Measured: From admission to discharge (2-3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start16 Nov 2021
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
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 SarcopeniaStudies 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
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thimo Marcin
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor-investigator, Thimo Marcin, Berner Reha Zentrum AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096013
- Sponsor's protocol ID
- 2021-01824
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2021
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Coiro M, Zurfluh A, Lehmann U, Brun P, Scheel-Sailer A, Tschanz H, van Hoof A, Wilhelm M, Marcin T. Effect of individual nutritional therapy during inpatient pulmonary rehabilitation in patients at risk for malnutrition and sarcopenia - a randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251350692. doi: 10.1177/14799731251350692. Epub 2025 Jun 15.
PubMed 40518743
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individual Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05096013
- Acronym / sponsor ID
- 2021-01824
- Conditions
- Sarcopenia, Malnutrition
- Keywords
- individual nutrition therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thimo MarcinUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 27 Oct 2021 (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.
Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses.
This study investigates the efficacy of individualized nutrition therapy (iNT) in pulmonary rehabilitation. Patients at significant risk for malnutrition already receive iNT within clinical routine during rehabilitation. The investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from iNT.
Detailed description
The participating patients are randomly assigned to two groups after giving written consent.
The intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. The iNT determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. Measures may include, for example, adjustments to the meal plan or nutritional supplementation. The measures are continuously adapted to the patients' needs.
The control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. However, patients from the control group do not receive additional counseling or adjustment by the iNT.
Patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. Average duration of rehabilitation is expected to be three weeks. As primary outcome, change in energy intake will be compared between groups. Additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| individual nutrition therapy | Experimental | Other: individual nutritional therapyIndividualized nutrition therapy: Specialists in nutritional counseling determine the patient's individual energy and protein needs and create targeted individual measures to achieve them. Measures can include, for example, adjustments to the menu, food enrichment or supplementation. The measures are discussed with the patients on an ongoing basis and adjusted as necessary. |
| usual care | No intervention | –Usual care: Participants in the control group receive a standardized food fortification of the soups with fat and protein, as well as an energy- and protein-rich dessert. No additional advice or adjustments are made by the iNT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia
- light to moderate risk of malnutrition (Nutritional Risk Score-2002: 3-4 Points)
- risk of sarcopenia (sarc-f >=4)
- signed informed consent
Key exclusion criteria (4 listed)
- medically described nutritional support
- reasons (cognitive, language) that prevent a informed consent
- enteral or parenteral nutrition
- after bariatric surgery
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 |
|---|---|---|
| individual nutritional therapyIntervention arm: Usual care + individualized nutritional therapy. Patients at risk for malnutrition and sarcopenia will receive a counselling by the nutritional therapist twice a week. The therapists will assess the patient's energy and protein demand in order to develope appropriate individual measures (e.g additional meals or supplements) to increase patients' energy and protein intake. Individual nutritional therapy is already usual care in patients with high risk for malnutrition, but not for patients with only light to moderate risk of malnutrition and risk of sarcopenia. | Other | individual nutrition therapy |
Primary outcome
Energy intake
Time frame: From admission to discharge (2-3 weeks)
Change in energy intake [kcal] from start to end of rehabilitation.
4 secondary outcomes
protein intake
Time frame: From admission to discharge (2-3 weeks)
grip strength
Time frame: From admission to discharge (2-3 weeks)
lean body mass
Time frame: From admission to discharge (2-3 weeks)
time up and go
Time frame: From admission to discharge (2-3 weeks)
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 Mar 2024.
- Derived from this study: PubMed 40518743Coiro M, Zurfluh A, Lehmann U, Brun P, Scheel-Sailer A, Tschanz H, van Hoof A, Wilhelm M, Marcin T. Effect of individual nutritional therapy during inpatient pulmonary rehabilitation in patients at risk for malnutrition and sarcopenia - a randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251350692. doi: 10.1177/14799731251350692. Epub 2025 Jun 15.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing individual nutritional therapy in people with Sarcopenia and Malnutrition, run by Thimo Marcin 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 4 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 13 Mar 2024. 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.
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?
Energy intake (time frame: From admission to discharge (2-3 weeks)). 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 NCT05096013, 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 Mar 2024.