Improvement of Sarcopenia in Patients Following Two Different Diets

Sarcopenia Clinical Trial

Official title:

Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03405727
• Other study ID #: CHUB-diet
• Status: Withdrawn
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: September 11, 2018

Study information

• Verified date: August 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Oral dietary supplements
Protein enriched diet

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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