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Improvement of Sarcopenia in Patients Following Two Different Diets

Primary Purpose

Sarcopenia

Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Oral dietary supplements
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients hospitalized within the CHU Brugmann, Brussels
  • Patients diagnosed with sarcopenia (by means of a dynamometer)
  • Patients having stayed in an intensive care unit for longer than 5 weeks

Exclusion Criteria:

  • Oncology patients
  • Anorexic patients
  • Patients having a life expectancy of less than 6 months
  • Demented patients
  • BPCO patients
  • Patients with neuropathies

Sites / Locations

  • CHU Brugmann

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment

Oral dietary supplements

Arm Description

Outcomes

Primary Outcome Measures

Prehension force
Prehension force, as measured by a dynamometer on the dominant hand
Prehension force
Prehension force, as measured by a dynamometer on the dominant hand
Fat mass evaluation
Measured by a Harpaden compass on the tricipital skin fold
Fat mass evaluation
Measured by a Harpaden compass on the tricipital skin fold
Muscle mass evaluation
Brachial muscular circumference (measured by tape)
Muscle mass evaluation
Brachial muscular circumference (measured by tape)
Walking speed
Walking speed on a 4 meters distance
Walking speed
Walking speed on a 4 meters distance
"Time Up and Go" test
Mobility assessment of the patient
"Time Up and Go" test
Mobility assessment of the patient
Sedentary lifestyle questionnaire
Evaluation of the physical activity by means of a questionnaire
Sedentary lifestyle questionnaire
Evaluation of the physical activity by means of a questionnaire

Secondary Outcome Measures

Full Information

First Posted
January 15, 2018
Last Updated
August 5, 2020
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03405727
Brief Title
Improvement of Sarcopenia in Patients Following Two Different Diets
Official Title
Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of human ressources
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

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
Sarcopenia is defined as a decrease in muscular strength and muscle mass, accompanied by a decrease in physical performance. Seniors might develop sarcopenia because of a decreased physical activity and a decreased protein intake. Many patients also develop sarcopenia after a long stay in an intensive care unit. Protein intake is very important when treating sarcopenia. However, meeting the protein requirements at home proves difficult. Oral dietary supplements, given in addition to the other known recommendations, might provide a solution. This study will assess the efficacy of the oral dietary supplements for the treatment of sarcopenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
No Intervention
Arm Title
Oral dietary supplements
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral dietary supplements
Intervention Description
Protein enriched diet
Primary Outcome Measure Information:
Title
Prehension force
Description
Prehension force, as measured by a dynamometer on the dominant hand
Time Frame
3 months after first consultation
Title
Prehension force
Description
Prehension force, as measured by a dynamometer on the dominant hand
Time Frame
6 months after first consultation
Title
Fat mass evaluation
Description
Measured by a Harpaden compass on the tricipital skin fold
Time Frame
3 months after first consultation
Title
Fat mass evaluation
Description
Measured by a Harpaden compass on the tricipital skin fold
Time Frame
6 months after first consultation
Title
Muscle mass evaluation
Description
Brachial muscular circumference (measured by tape)
Time Frame
3 months after first consultation
Title
Muscle mass evaluation
Description
Brachial muscular circumference (measured by tape)
Time Frame
6 months after first consultation
Title
Walking speed
Description
Walking speed on a 4 meters distance
Time Frame
3 months after first consultation
Title
Walking speed
Description
Walking speed on a 4 meters distance
Time Frame
6 months after first consultation
Title
"Time Up and Go" test
Description
Mobility assessment of the patient
Time Frame
3 months after first consultation
Title
"Time Up and Go" test
Description
Mobility assessment of the patient
Time Frame
6 months after first consultation
Title
Sedentary lifestyle questionnaire
Description
Evaluation of the physical activity by means of a questionnaire
Time Frame
3 months after first consultation
Title
Sedentary lifestyle questionnaire
Description
Evaluation of the physical activity by means of a questionnaire
Time Frame
6 months after first consultation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients hospitalized within the CHU Brugmann, Brussels Patients diagnosed with sarcopenia (by means of a dynamometer) Patients having stayed in an intensive care unit for longer than 5 weeks Exclusion Criteria: Oncology patients Anorexic patients Patients having a life expectancy of less than 6 months Demented patients BPCO patients Patients with neuropathies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turkan Dalgic
Organizational Affiliation
Haute Ecole Lucia De Brouckère
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improvement of Sarcopenia in Patients Following Two Different Diets

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