Clinical trial NCT03666013: Mitochondria and Muscle Health in Elderly
Official title: Mitochondrial Health and Muscle Function in Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Weakness
Keywords: Mitochondrial health
Muscle function
Aging
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: Top Institute Food and Nutrition
First posted: 2018-09-11
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers between 20 and 30 years old and 65 and 80 years old

Brief summary: The aim of this study is to characterize the relation between skeletal muscle mitochondrial metabolism and muscle health in elderly, physically compromised humans. To study this relation, a cross-sectional study will be performed in well-defined, distinct subject groups. Thus, to obtain insight in the relation between mitochondrial health and muscle function, not only subjects that differ in mitochondrial function (based on physical activity) will be compared but also subjects with high- versus low muscle function will be selected.

Detailed description: Aging is associated with a decline of mitochondrial and skeletal muscle volume, -quality and -function. If a causal link exists between the loss of mitochondrial function and muscle health is unknown, however, both appear with advancing age and are associated with the loss of functional capacity, which increases comorbidities and annual healthcare costs. The aim is to test the hypothesis that a compromised muscle function in sedentary elderly is related to an impaired mitochondrial health. A detailed characterization of mitochondrial metabolism and muscle function is performed in well-defined, (physically compromised) elderly humans, in a cross-sectional design. To obtain insight in the relation between mitochondrial health and muscle function, not only elderly subjects that differ in mitochondrial function (based on physical activity) will be compared but also elderly subjects with high versus low muscle physical function will be selected. Healthy, young (20-30 years,) individuals with normal physical activity levels will be included as absolute controls.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Subject should be in sufficient health to participate in the experimentations, to be judged by the responsible MD based on the subject's medical history
* Caucasian origin (see study groups)

Exclusion Criteria:

* Any contraindications for MRI scan:

Aneurysm clips Implanted neural stimulator Implanted cardiac pacemaker of defibrillator Cochlear implant Iron- containing corpora aliena in the eye or brain Artificial (heart) valves which is contraindicated for MRS Claustrophobia

* Diagnosed with diabetes mellitus
* Poor health as judged by the responsible medical doctor
* Heart problems: In case of an abnormal ECG in rest, this will be discussed with both the participant and the responsible medical doctor

Primary outcomes:
measure: Rate of ex vivo mitochondrial State 3 respiration
timeFrame: Day 4
Secondary outcomes:
measure: Insuline sensitivity
timeFrame: Day 1
measure: Physical functionality, 6MWT
timeFrame: Day 2
measure: VO2max
timeFrame: Day 2
measure: Body composition
timeFrame: Day 3
measure: Dynamic gait stability
timeFrame: Day 3
measure: Muscle strength in upper-leg
timeFrame: Day 3
measure: Energy expenditure in rest and during sub-maximal exercise
timeFrame: Day 4
measure: Muscle oxidative capacity in vivo (PCr-MRS recovery)
timeFrame: Day 5
measure: Muscle metabolism in vivo (H-MRS acetylcarnitine)
timeFrame: Day 5
measure: Muscle volume upper-leg
timeFrame: Day 5
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Patrick Schrauwen, Prof . dr.
role: PRINCIPAL_INVESTIGATOR
References: