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Carnitine status in fit and pre-frail/frail elderly compared to healthy young individuals


- candidate number25527
- NTR NumberNTR6124
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2016
- Secondary IDsNL58289.081.16 METC-WU
- Public TitleCarnitine status in fit and pre-frail/frail elderly compared to healthy young individuals
- Scientific TitleCarnitine status in fit and pre-frail/frail elderly compared to healthy young individuals
- ACRONYMFitaal
- hypothesisWe hypothesize that declined intramuscular carnitine levels are associated to declined mitochondrial function and, subsequently, to the frailty score. We suspect that prefrail/ frail elderly will have the lowest intramuscular carnitine levels and mitochondrial function compared to the fit elderly and healthy young individuals, whereas fit elderly will have higher intramuscular carnitine status and mitochondrial function compared to pre-frail/ frail elderly, but lower compared to healthy young individuals.
- Healt Condition(s) or Problem(s) studiedOlder adults, Frailty, Mitochondrail function
- Inclusion criteriaHealthy young subjects
- 20-30 years of age
- BMI of 20-25 kg/m2

Healthy fit elderly
- 75 years or older
- Fried score = 0

Pre-frail/frail elderly
- 75 years or older
- Fried score of 1 or more
- Exclusion criteria- Contra-indication for DEXA-scan, e.g. metal splinters
- Contra-indication for muscle biopsy, e.g. use of anticoagulants.
- a significant medical or surgical event or hospitalization within the previous three months
- currently or the last three months treated by a medical specialist
- diagnosed with cardiac failure, COPD or anaemia
- diagnosed dementia and not having access to a daily caregiver and not able to make their own trade-off, which will be assessed at our discretion. The potential subjects have to be able to reproduce what is said;
- diagnosed with cancer or receiving cancer treatment
- not able to understand the Dutch language
- Diagnosed neuromuscular disorders
- taking carnitine supplements
- current participation in other research
- usage of the following medications:
o Systemic corticosteroids
o Fibrates
o Valproic acid
o Emetine
o Zidovudine

Additional exclusion criteria for the young individuals:
- Pregnant and nursing women
- Diabetes Mellitus type I and II
- Limited amount of performing sports, not more than 5 times a week
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 16-jan-2017
- planned closingdate23-jun-2017
- Target number of participants78
- InterventionsA blood sample and muscle biopsy. In addition, participants will perform several physical and cognitive tests and fill in questionnaires.
- Primary outcomeIntramuscular carnitine levels and carnitine derivatives
- Secondary outcomeCarnitine status and its derivatives in PBMCs
Mitochondrial function in muscle tissue and PBMCs
Fat and fat-free mass
Plasma carnitine and its derivatives
Short Physical Performance Battery (SPPB)
400m walk time
Cognitive function
- TimepointsAll parameters will be measured within two weeks.
- Trial web sitewww.fitaalstudie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. van der Hoek
- CONTACT for SCIENTIFIC QUERIES M. van der Hoek
- Sponsor/Initiator VHL University of Applied Science
- Funding
(Source(s) of Monetary or Material Support)
VHL University of Applied Science, Medisch Centrum Leeuwarden, Wageningen University, Sigma Tau BV, Province Fryslan
- Publications
- Brief summaryAgeing is associated with increasing physical disabilities and prevalence of frailty, which negatively affects quality of life. In addition, ageing is also associated with a decrease in intramuscular carnitine levels. Simultaneously, intramuscular mitochondrial content and function decline. There are three studies describing the decline in intramuscular carnitine levels during ageing, but none of these studies did measure if frailty status is associated with the degree of decline in carnitine status and mitochondrial function. In this study we are going to test the hypothesize that declined intramuscular carnitine levels are associated to declined mitochondrial function and, subsequently, to the frailty score. Therefore the main objective is to compare the intramuscular carnitine status of prefrail/ frail elderly with fit elderly and young individuals. The secondary objectives are; 1) determine if intramuscular carnitine status is associated with carnitine levels in PBMCs; 2) compare lean mass, physical function, muscle function/strength, cognitive function and mitochondrial function in skeletal muscle and PBMCs between fit and pre-frail/frail elderly, by using the healthy young individuals as a reference group.
- Main changes (audit trail)
- RECORD14-nov-2016 - 3-jan-2017


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