Geriatric PatientsHohMal2NCT03493100
Hohenheim Malnutrition Study in Geriatric Fracture Patients
A study testing oral nutritional supplementation in people with Geriatric Patients, run by University of Hohenheim at 1 site in Germany.
Trial summary
The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2016to 25 Oct 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 75 years, or
- age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
- written informed consent
Who cannot join
- progressive cancer disease
- relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
- insufficient German speech intelligibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.
- Conditions
- Geriatric Patients
- Being tested
- oral nutritional supplementation, Usual care
- Keywords
- oral nutritional supplementation, geriatrics, bone fracture
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementationDietary supplement
The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.
Usual careOther
The control group will receive treatment according to usual care.
| Study group | Role | What they receive |
|---|---|---|
| oral nutritional supplementation | Experimental | This group receives optimized nutritional support, by ONS for a period of four weeks. Receives: Dietary Supplement: oral nutritional supplementation |
| Control | Other | The control group will receive treatment according to usual care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand grip strength
The primary endpoint is the change in muscle functionality of the study groups after 4 weeks by the measurement of hand grip strength using Jamar®-Dynamometer.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Secondary outcomes (18)
Nutritional status
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Mobility
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Arm/leg circumference
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Skinfold thickness
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Quality of life
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Activity of daily living (ADL) questionnaire and EQ-5-DL questionnaire.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Comorbidity rate
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Medical condition
Difference between intervention and control group at discharge and after 4 weeks.
Measured: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Sarcopenia prevalence
Difference between intervention and control group at discharge and after 4 weeks.
Measured: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Phase angle
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Routine laboratory tests (serum plasma)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin D in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin B12 in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Folic acid in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
CRP (C-reactive protein) in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BCM (body cell mass)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Body weight
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BMI (body mass index)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Measured: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 Sep 2016
- Primary completion30 Apr 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan C. Bischoff, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493100
- Sponsor's protocol ID
- HohMal2
- Acronym
- HohMal2
- Status last verified
- Apr 2018
- First submitted
- 21 Jun 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
- ClinicalTrials.gov ID
- NCT03493100
- Acronym / sponsor ID
- HohMal2 / HohMal2
- Conditions
- Geriatric Patients
- Keywords
- oral nutritional supplementation, geriatrics, bone fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 10 Apr 2018 (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.
The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral nutritional supplementation | Experimental | Dietary Supplement: oral nutritional supplementationThis group receives optimized nutritional support, by ONS for a period of four weeks. |
| Control | Other | Other: Usual careThe control group will receive treatment according to usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age ≥ 75 years, or
- age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
- written informed consent
Key exclusion criteria (3 listed)
- progressive cancer disease
- relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
- insufficient German speech intelligibility
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 |
|---|---|---|
| oral nutritional supplementationThe intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day. | Dietary supplement | oral nutritional supplementation |
| Usual careThe control group will receive treatment according to usual care. | Other | Control |
Primary outcome
hand grip strength
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
The primary endpoint is the change in muscle functionality of the study groups after 4 weeks by the measurement of hand grip strength using Jamar®-Dynamometer.
18 secondary outcomes
Nutritional status
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Mobility
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Arm/leg circumference
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Skinfold thickness
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Quality of life
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Comorbidity rate
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Medical condition
Time frame: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Sarcopenia prevalence
Time frame: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Phase angle
Time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.
Routine laboratory tests (serum plasma)
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin D in serum
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Vitamin B12 in serum
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Folic acid in serum
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
CRP (C-reactive protein) in serum
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BCM (body cell mass)
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Body weight
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
BMI (body mass index)
Time frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
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 26 Oct 2018.
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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.
Stephan C. Bischoff principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplementation in people with Geriatric Patients, run by University of Hohenheim 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 3 inclusion and 3 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 26 Oct 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 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?
hand grip strength (time frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months.). 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 26 Oct 2018; AzTrials last refreshed its copy on 6 Nov 2026.