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MalnutitrionNuTraNCT07582575

Nutrition and Trauma - The Influence of Malnutrition in Geriatric Trauma Patients

A study testing Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day in people with Malnutitrion, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Due to demographic changes, the geriatric patient population is growing, leading to a higher incidence of osteoporotic fractures associated with multimorbidity and frailty. Up to 60% of elderly patients are at risk of malnutrition, which is associated with a high rate of post-operative complications, prolonged… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Malnutitrion
What is being tested?
Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteGermany
Study dates
1 May 2024to 1 Jun 2025
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients aged ≥70 years
  • Acute fractures of the proximal humerus, vertebral body, pelvis, acetabulum, proximal femur, or periprosthetic fractures of the lower extremity
  • Admission for acute fracture management
  • Ability to provide written informed consent

Who cannot join

  • Age <70 years
  • Dementia or relevant cognitive impairment precluding informed consent
  • Progressive malignancy
  • Palliative treatment goals
  • Refusal or inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Department of Trauma and Reconstructive Surgery, University of Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: Nutrition and Trauma (NuTra) - The Influence of Malnutrition in Geriatric Trauma Patients

Due to demographic changes, the geriatric patient population is growing, leading to a higher incidence of osteoporotic fractures associated with multimorbidity and frailty. Up to 60% of elderly patients are at risk of malnutrition, which is associated with a high rate of post-operative complications, prolonged hospitalisation, poorer return to independence and increased mortality.

The NuTra study investigates the prevalence of malnutrition, evaluates screening tools and analyses the impact of protein-rich diets on postoperative outcomes in geriatric trauma. The aim is to develop evidence-based approaches to the prevention and treatment of malnutrition in order to improve the medical outcome and quality of life of geriatric trauma patients and reduce healthcare costs.

Read the detailed description

Rising life expectancy in Germany-with an average of 78.3 years for men and 83.2 years for women in 2022-is leading to a growing geriatric patient population and posing new challenges for the healthcare system. In clinical practice, individuals aged 65 years and older are generally considered geriatric patients. The incidence of osteoporotic fractures increases with age. These fractures, often resulting from low-energy falls, are frequently the consequence of multimorbidity and increased frailty.

Proximal femur fractures are among the most common fractures requiring inpatient treatment in Germany and are associated with a one-year mortality rate of up to 28%. In addition to osteoporosis, affected patients often present with multiple chronic conditions, contributing to reduced quality of life and substantially increased healthcare costs.

The risk of malnutrition, as assessed by the Nutritional Risk Screening (NRS), is high in geriatric patients in orthopaedics and trauma surgery and increases with age (approximately 31% in patients aged 65-80 years and up to 60% in those over 80 years). Malnutrition is associated with higher rates of postoperative complications (37.2% vs. 21.1%), prolonged hospital stay (18.2 ± 11.7 vs. 13.7 ± 11.1 days), delayed mobilisation, and impaired recovery of autonomy. It is also linked to increased six-month mortality following proximal femur fractures.

Geriatric trauma patients are typically in a catabolic state, particularly in the preoperative phase, which is further exacerbated by the combined effects of trauma, surgery, and perioperative fasting. This often results in metabolic imbalances that may persist for several weeks and increase the risk of complications such as delirium. Despite improvements in care structures, osteoporotic fractures remain a major life event, with only a minority of patients regaining their pre-fracture functional status and independence.

The management of geriatric trauma patients therefore requires an interdisciplinary and comprehensive approach aimed at restoring function, maintaining independence, and preserving quality of life. A key component of this approach-yet still insufficiently addressed-is the early identification and targeted treatment of malnutrition.

Conditions
Malnutitrion
Being tested
Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day
Keywords
randomised controlled interventional study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per dayDietary supplement

    The intervention group A received a structured protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day, in accordance with current recommendations for older adults with acute illness. This regimen combined three protein-rich main meals per day with oral nutritional supplements providing 20 g protein per serving.

Study groups in NCT07582575
Study groupRoleWhat they receive
Group A InterventionExperimentalMalnourished patients in Group A received a structured protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day
Receives: Dietary Supplement: Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day
Group B ControlNo interventionPatients in the malnourished control group (B) received standard hospital whole food diet without targeted protein enrichment or routine provision of oral nutritional supplements
Group C ControlNo interventionPatients in the well-nourished control group (C) received standard hospital whole food diet without targeted protein enrichment or routine provision of oral nutritional supplements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with medical complications during index hospitalization

    Number of participants with one or more medical complications during the index hospitalization, including acute kidney injury, urinary tract infection, pneumonia, or deep vein thrombosis.

    Measured: Day 1 (Baseline, Hospital admission) up to 3 weeks.

  2. Number of participants with surgical site infection during index hospitalization

    Number of operatively treated participants with surgical site infection during the index hospitalization, defined according to standard clinical and microbiological criteria.

    Measured: Postoperative day 1 up to 3 weeks postoperative.

  3. Functional mobility at discharge

    Functional mobility at discharge, categorized as: independent mobilization, mobilization with assistive devices (e.g. walking frame, crutches), assisted standing or bedbound.

    Measured: Day 1 (Baseline, Hospital admission) up to 3 weeks.

Secondary outcomes (3)
  1. Length of index hospital stay

    Length of index hospital stay, measured in days

    Measured: Day 1 (Baseline, Hospital admission) up to 3 weeks.

  2. Discharge destination at hospital discharge

    Discharge destination, categorized as: independent at home, community-based support or institutional care (e.g. nursing home, rehabilitation facility)

    Measured: At discharge from the index hospital stay, up to 3 weeks

  3. In-hospital mortality during the index hospital stay

    Number of participants who die during the index hospitalization.

    Measured: Day 1 (Baseline, Hospital admission) up to 3 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start1 May 2024
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

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
Prospective randomized controlled parallel-group interventional study comparing structured nutritional management with standard care in geriatric trauma patients.
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07582575
Sponsor's protocol ID
NuTra
Acronym
NuTra
Status last verified
May 2026
First submitted
23 Mar 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Krupp S, Freiberger E, Renner C, Hofmann W. [Assessment of mobility/motor skills in old age : Based on the S1 guideline "Geriatric assessment level 2, living guideline"]. Z Gerontol Geriatr. 2022 May;55(3):239-248. doi: 10.1007/s00391-022-02060-4. Epub 2022 Apr 20. German.

    PubMed 35441870
  • Rapp K, Rothenbacher D, Magaziner J, Becker C, Benzinger P, Konig HH, Jaensch A, Buchele G. Risk of Nursing Home Admission After Femoral Fracture Compared With Stroke, Myocardial Infarction, and Pneumonia. J Am Med Dir Assoc. 2015 Aug 1;16(8):715.e7-715.e12. doi: 10.1016/j.jamda.2015.05.013. Epub 2015 Jul 2.

    PubMed 26142060
  • Schoeneberg C, Knobe M, Babst R, Friess T, Volland R, Hartwig E, Schmidt W, Lendemans S, Buecking B; AltersTraumaRegister DGU. [120-day follow-up after proximal femoral fractures-first results from the Geriatric Trauma Registry DGU(R)]. Unfallchirurg. 2020 May;123(5):375-385. doi: 10.1007/s00113-019-00730-4. German.

    PubMed 31598740
  • Arkley J, Dixon J, Wilson F, Charlton K, Ollivere BJ, Eardley W. Assessment of Nutrition and Supplementation in Patients With Hip Fractures. Geriatr Orthop Surg Rehabil. 2019 Oct 17;10:2151459319879804. doi: 10.1177/2151459319879804. eCollection 2019.

    PubMed 31667002
  • Irisawa H, Mizushima T. Relationship between Nutritional Status, Body Composition, Muscle Strength, and Functional Recovery in Patients with Proximal Femur Fracture. Nutrients. 2022 May 30;14(11):2298. doi: 10.3390/nu14112298.

    PubMed 35684096
  • Bucking B, Neuerburg C, Knobe M, Liener U. [Treatment of patients with fragility fractures]. Unfallchirurg. 2019 Oct;122(10):755-761. doi: 10.1007/s00113-019-00707-3. German.

    PubMed 31428807
  • Kammerlander C, Blauth M, Gosch M, Bocker W. [Co-management in geriatric traumatology]. Orthopade. 2015 Sep;44(9):681-685. doi: 10.1007/s00132-015-3144-6. German.

    PubMed 26205359
  • Berk T, Thalmann M, Jensen KO, Schwarzenberg P, Jukema GN, Pape HC, Halvachizadeh S. Implementation of a novel nursing assessment tool in geriatric trauma patients with proximal femur fractures. PLoS One. 2023 Jun 9;18(6):e0284320. doi: 10.1371/journal.pone.0284320. eCollection 2023.

    PubMed 37294793
  • Becker N, Hafner T, Pishnamaz M, Hildebrand F, Kobbe P. Patient-specific risk factors for adverse outcomes following geriatric proximal femur fractures. Eur J Trauma Emerg Surg. 2022 Apr;48(2):753-761. doi: 10.1007/s00068-022-01953-8. Epub 2022 Mar 24.

    PubMed 35325262
  • Walter N, Rupp M, Lang S, Alt V. The epidemiology of fracture-related infections in Germany. Sci Rep. 2021 May 17;11(1):10443. doi: 10.1038/s41598-021-90008-w.

    PubMed 34001973
  • Malafarina V, Reginster JY, Cabrerizo S, Bruyere O, Kanis JA, Martinez JA, Zulet MA. Nutritional Status and Nutritional Treatment Are Related to Outcomes and Mortality in Older Adults with Hip Fracture. Nutrients. 2018 Apr 30;10(5):555. doi: 10.3390/nu10050555.

    PubMed 29710860
  • Gumieiro DN, Rafacho BP, Goncalves AF, Tanni SE, Azevedo PS, Sakane DT, Carneiro CA, Gaspardo D, Zornoff LA, Pereira GJ, Paiva SA, Minicucci MF. Mini Nutritional Assessment predicts gait status and mortality 6 months after hip fracture. Br J Nutr. 2013 May;109(9):1657-61. doi: 10.1017/S0007114512003686. Epub 2012 Sep 28.

    PubMed 23017491
  • Rupp M, Walter N, Pfeifer C, Lang S, Kerschbaum M, Krutsch W, Baumann F, Alt V. The Incidence of Fractures Among the Adult Population of Germany-an Analysis From 2009 through 2019. Dtsch Arztebl Int. 2021 Oct 8;118(40):665-669. doi: 10.3238/arztebl.m2021.0238.

    PubMed 34140088
  • Vogel C, Heyl M, Vollmer L, Schuhmacher J, Demissie J, Haas D, Braun BJ, Herath SC, Histing T, Rollmann MF. Impact of malnutrition and protein-enriched oral nutrition on early recovery after fragility fractures in older adults: the NuTra trial. BMC Geriatr. 2026 Oct 17;26(1):1350. doi: 10.1186/s12877-026-08247-3.

    PubMed 42934566

Questions about this trial

What is this clinical trial studying?

A study testing Protein-enriched nutritional regimen with a targeted total protein intake of 1.5-2.0 g/kg body weight per day in people with Malnutitrion, run by Department of Trauma and Reconstructive Surgery at Eberhard Karls University Tuebingen, BG Klinik Tu at 1 site in Germany.

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 5 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 May 2026. 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 Germany. 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?

Number of participants with medical complications during index hospitalization (time frame: Day 1 (Baseline, Hospital admission) up to 3 weeks.). The study lists 3 primary outcomes in all. 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 NCT07582575, which also lists 14 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 13 May 2026.

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