NCT03405727

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2018

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

January 15, 2018

Last Update Submit

August 5, 2020

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

Standard treatment

NO INTERVENTION

Oral dietary supplements

EXPERIMENTAL
Dietary Supplement: Oral dietary supplements

Interventions

Oral dietary supplementsDIETARY_SUPPLEMENT

Protein enriched diet

Oral dietary supplements

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Turkan Dalgic

    Haute Ecole Lucia De Brouckère

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

March 20, 2018

Primary Completion

September 11, 2018

Study Completion

September 11, 2018

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)