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Hohenheim Malnutrition Study in Geriatric Fracture Patients (HohMal2)

Primary Purpose

Geriatric Patients

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
oral nutritional supplementation
Usual care
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geriatric Patients focused on measuring oral nutritional supplementation, geriatrics, bone fracture

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥ 75 years, or
  • age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
  • written informed consent

Exclusion Criteria:

  • progressive cancer disease
  • relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
  • insufficient German speech intelligibility

Sites / Locations

  • University of Hohenheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

oral nutritional supplementation

Control

Arm Description

This group receives optimized nutritional support, by ONS for a period of four weeks.

The control group will receive treatment according to usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Nutritional status
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).
Mobility
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).
Arm/leg circumference
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Skinfold thickness
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Comorbidity rate
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Medical condition
Difference between intervention and control group at discharge and after 4 weeks.
Sarcopenia prevalence
Difference between intervention and control group at discharge and after 4 weeks.
Phase angle
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Routine laboratory tests (serum plasma)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Vitamin D in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Vitamin B12 in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
Folic acid in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
CRP (C-reactive protein) in serum
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
BCM (body cell mass)
Difference between intervention and control group at discharge and after 4 weeks follow-up.
Body weight
Difference between intervention and control group at discharge and after 4 weeks follow-up.
BMI (body mass index)
Difference between intervention and control group at discharge and after 4 weeks follow-up.

Full Information

First Posted
June 21, 2017
Last Updated
October 25, 2018
Sponsor
University of Hohenheim
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1. Study Identification

Unique Protocol Identification Number
NCT03493100
Brief Title
Hohenheim Malnutrition Study in Geriatric Fracture Patients
Acronym
HohMal2
Official Title
Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 15, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hohenheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geriatric Patients
Keywords
oral nutritional supplementation, geriatrics, bone fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral nutritional supplementation
Arm Type
Experimental
Arm Description
This group receives optimized nutritional support, by ONS for a period of four weeks.
Arm Title
Control
Arm Type
Other
Arm Description
The control group will receive treatment according to usual care.
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutritional supplementation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The control group will receive treatment according to usual care.
Primary Outcome Measure Information:
Title
hand grip strength
Description
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.
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.
Secondary Outcome Measure Information:
Title
Nutritional status
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).
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.
Title
Mobility
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).
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.
Title
Arm/leg circumference
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Extracellular to body cell mass ratio (ECM/BCM - Ratio)
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Skinfold thickness
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Quality of life
Description
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.
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.
Title
Comorbidity rate
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Medical condition
Description
Difference between intervention and control group at discharge and after 4 weeks.
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.
Title
Sarcopenia prevalence
Description
Difference between intervention and control group at discharge and after 4 weeks.
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.
Title
Phase angle
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Routine laboratory tests (serum plasma)
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Vitamin D in serum
Description
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Vitamin B12 in serum
Description
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Folic acid in serum
Description
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
CRP (C-reactive protein) in serum
Description
Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
BCM (body cell mass)
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
Body weight
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.
Title
BMI (body mass index)
Description
Difference between intervention and control group at discharge and after 4 weeks follow-up.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age ≥ 75 years, or age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and written informed consent Exclusion Criteria: progressive cancer disease relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters) insufficient German speech intelligibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C. Bischoff
Organizational Affiliation
University of Hohenheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hohenheim
City
Stuttgart
ZIP/Postal Code
70599
Country
Germany

12. IPD Sharing Statement

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Hohenheim Malnutrition Study in Geriatric Fracture Patients

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