NL-OMON36746RecruitingNot Applicable
Clinical outcome and cost effectiveness analysis of nutritional rehabilitation on physical functioning and cardiometabolic risk profile in COPD patients with muscle atrophy - NUTRAIN study
Medisch Universitair Ziekenhuis Maastricht0 sites120 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Clinically stable COPD patients with muscle atrophy eligible for pulmonary rehabilitation. Based on recent studies in COPD and health reference groups, muscle atrophy is defined as a fat-free mass index (FFMI) under the sex- and age-specific 25th percentile FFMI values, assessed by DEXA.
- •Subjects have to be aged over 18, may not get pregnant during the study and have to stop possible intake of current nutritional supplements.Eligible patients will be included after signing informed consent.
Exclusion Criteria
- •-COPD patients under the age of 18;
- •-Allergy or intolerance to fish, milk or other product components;
- •-Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements;
- •-Not able to stop current supplement use or if total use will be above safe upper limits;
- •-Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
- •-Pregnancy;
- •-Life threatening diseases like tuberculosis, carcinoma, AIDS (including HIV+), acute leukaemia etc.
Investigators
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