Hohenheim Malnutrition Study in Geriatric Fracture Patients

Geriatric Patients Clinical Trial

— HohMal2  

Official title:

Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493100
• Other study ID #: HohMal2
• Status: Completed
• Phase: N/A
• Start date: September 15, 2016
• Est. completion date: October 25, 2018

Study information

• Verified date: April 2018
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 25, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatric Patients

Intervention

Dietary Supplement:
• oral nutritional supplementation
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.

Other:
• Usual care
The control group will receive treatment according to usual care.

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Nutritional status	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).	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	Mobility	Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).	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	Arm/leg circumference	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Extracellular to body cell mass ratio (ECM/BCM - Ratio)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Skinfold thickness	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	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.	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	Comorbidity rate	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Medical condition	Difference between intervention and control group at discharge and after 4 weeks.	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	Sarcopenia prevalence	Difference between intervention and control group at discharge and after 4 weeks.	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	Phase angle	Difference between intervention and control group at discharge and after 4 weeks follow-up.	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	Routine laboratory tests (serum plasma)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	Vitamin D in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	Vitamin B12 in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	Folic acid in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	CRP (C-reactive protein) in serum	Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	BCM (body cell mass)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	Body weight	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.
Secondary	BMI (body mass index)	Difference between intervention and control group at discharge and after 4 weeks follow-up.	Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months.