The main objective is to compare the intramuscular carnitine status of pre-frail/frail elderly with fit elderly and young individuals. The secondary objectives are; 1) determine if intramuscular carnitine status is associated with carnitine levels…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study paramater is intramuscular carnitine levels and the
intramuscular carnitine derivatives.
Secondary outcome
The secondary study parameters are:
- carnitine status and its derivates in PBMCs
- mitochondrial function in muscle tissue and PBMCs
- Fat and fat-free mass
- Plasma carnitine and its derivatives
- Short Physical Performance Battery
- 400m walk time
- Cognitive function
Background summary
Ageing 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. We suspect that pre-frail/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.
Study objective
The main objective is to compare the intramuscular carnitine status of
pre-frail/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
Study design
Cross-sectional study
Study burden and risks
In total (including screening), the subjects will visit 3 times the research
location. The screening will take about 1 hour for healthy young individuals
and 1.5 hours for the elderly. Day 1 of the study will take about 1 hour for
young individuals and 2.5 hours for the elderly. Day 2 of the study will take
about 1 hours for both the young individuals and the elderly, subsequently a
breakfast will be provided to the participants.
One muscle biopsy will be taken during this study. Despite local anaesthesia,
there is a small risk of pain during the procedure. In exceptional cases, there
can be a minor bleeding afterwards and occurrence of infections. In addition,
subjects will undergo a DEXA-scan, whereof regarding the radiation the risks
are negligible. Furthermore, there is a small risk of bruising and sore muscles
regarding the blood sampling procedures.
Furthermore the subjects will perform a 3-day food diary.
The elderly will also perform a 400-m walk test, cognitive tests, and several
balance and physical tests.
De elst 1
Wageningen 6708 WD
NL
De elst 1
Wageningen 6708 WD
NL
Listed location countries
Age
Inclusion criteria
Healthy young subjects (n <= 26):
* 20 * 30 years of age
* BMI of 20 * 25 kg/m2;Healthy fit elderly subjects (n <= 26):
* * 75 years of age
* Fried score <= 0 ;Pre-frail/frail elderly (n<=26):
* * 75 years of age
* Fried score * 1*;Male/female ratio of the different groups will be matched.
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58289.081.16 |
| OMON | NL-OMON26053 |