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Improvement of Sarcopenia in Patients Following Two Different Diets

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ClinicalTrials.gov Identifier: NCT03405727
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Tatiana Besse-Hammer, Brugmann University Hospital

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.


Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Oral dietary supplements Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Sarcopenia in Sarcopenia Patients Following Two Different Diets
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard treatment
Experimental: Oral dietary supplements Dietary Supplement: Oral dietary supplements
Protein enriched diet




Primary Outcome Measures :
  1. Prehension force [ Time Frame: 3 months after first consultation ]
    Prehension force, as measured by a dynamometer on the dominant hand

  2. Prehension force [ Time Frame: 6 months after first consultation ]
    Prehension force, as measured by a dynamometer on the dominant hand

  3. Fat mass evaluation [ Time Frame: 3 months after first consultation ]
    Measured by a Harpaden compass on the tricipital skin fold

  4. Fat mass evaluation [ Time Frame: 6 months after first consultation ]
    Measured by a Harpaden compass on the tricipital skin fold

  5. Muscle mass evaluation [ Time Frame: 3 months after first consultation ]
    Brachial muscular circumference (measured by tape)

  6. Muscle mass evaluation [ Time Frame: 6 months after first consultation ]
    Brachial muscular circumference (measured by tape)

  7. Walking speed [ Time Frame: 3 months after first consultation ]
    Walking speed on a 4 meters distance

  8. Walking speed [ Time Frame: 6 months after first consultation ]
    Walking speed on a 4 meters distance

  9. "Time Up and Go" test [ Time Frame: 3 months after first consultation ]
    Mobility assessment of the patient

  10. "Time Up and Go" test [ Time Frame: 6 months after first consultation ]
    Mobility assessment of the patient

  11. Sedentary lifestyle questionnaire [ Time Frame: 3 months after first consultation ]
    Evaluation of the physical activity by means of a questionnaire

  12. Sedentary lifestyle questionnaire [ Time Frame: 6 months after first consultation ]
    Evaluation of the physical activity by means of a questionnaire



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405727


Contacts
Contact: Turkan Dalgic 32 2 4772833 dalgic.turkan@hotmail.fr

Locations
Belgium
CHU Brugmann Not yet recruiting
Brussels, Belgium, 1020
Contact: Turkan Dalgic       dalgic.turkan@hotmail.com   
Sponsors and Collaborators
Brugmann University Hospital
Investigators
Principal Investigator: Turkan Dalgic Haute Ecole Lucia De Brouckère

Responsible Party: Tatiana Besse-Hammer, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03405727     History of Changes
Other Study ID Numbers: CHUB-diet
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms