Improvement of Sarcopenia in Patients Following Two Different Diets

Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets

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.

Study Overview

• Status: Withdrawn
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Oral dietary supplements

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard treatment
Experimental: Oral dietary supplements	Dietary supplement: Oral dietary supplements; Protein enriched diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prehension force	Prehension force, as measured by a dynamometer on the dominant hand	3 months after first consultation
Prehension force	Prehension force, as measured by a dynamometer on the dominant hand	6 months after first consultation
Fat mass evaluation	Measured by a Harpaden compass on the tricipital skin fold	3 months after first consultation
Fat mass evaluation	Measured by a Harpaden compass on the tricipital skin fold	6 months after first consultation
Muscle mass evaluation	Brachial muscular circumference (measured by tape)	3 months after first consultation
Muscle mass evaluation	Brachial muscular circumference (measured by tape)	6 months after first consultation
Walking speed	Walking speed on a 4 meters distance	3 months after first consultation
Walking speed	Walking speed on a 4 meters distance	6 months after first consultation
"Time Up and Go" test	Mobility assessment of the patient	3 months after first consultation
"Time Up and Go" test	Mobility assessment of the patient	6 months after first consultation
Sedentary lifestyle questionnaire	Evaluation of the physical activity by means of a questionnaire	3 months after first consultation
Sedentary lifestyle questionnaire	Evaluation of the physical activity by means of a questionnaire	6 months after first consultation

Collaborators and Investigators

• Sponsor: Brugmann University Hospital
• Investigators: Principal Investigator: Turkan Dalgic, Haute Ecole Lucia De Brouckère

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: CHUB-diet

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No