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Completed

NCT Number: NCT03666013

Mitochondria and Muscle Health in Elderly

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.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of ex vivo mitochondrial State 3 respiration

    Time frame: Day 4

    Ex vivo mitochondrial capacity, ADP-stimulated respiration expressed by O2flux in pmol/mg wet weight/second

Secondary outcomes

  1. Insuline sensitivity

    Time frame: Day 1

    Measured by 1-step hyperinsulinemic euglycemic. Insulin-stimulated glucose disposal, expressed as the rate of disappearance of the glucose (Rd glucose in μmol*kg-1*bw*min-1

  2. Physical functionality, 6MWT

    Time frame: Day 2

    Measured by a standardized 6-minute walk test. Physical functionality expressed in the distance (in meters) the subject is able to walk over a total of six minutes

  3. VO2max

    Time frame: Day 2

    Maximal oxygen uptake measured by maximal cycling test (ml*kg-1*min-1)

  4. Body composition

    Time frame: Day 3

    Measured by BodPod and expressed by percentages of fat mass (%)

  5. Dynamic gait stability

    Time frame: Day 3

    Characterized by using the CAREN-system locomotion assessment and expressed by amount of steps necessary to regain normal walking pattern

  6. Muscle strength in upper-leg

    Time frame: Day 3

    Extensor and flexor muscles of the knee joint measured by dynamometer (Biodex) expressed in peak torque 70° extension and flexion knee (Nm/kg)

  7. Energy expenditure in rest and during sub-maximal exercise

    Time frame: Day 4

    indirect calorimetry during 45 minutes in resting state (in KJ/min) and 1-hour exercise bout at 50% of maximal power output (in KJ/min)

  8. Muscle oxidative capacity in vivo (PCr-MRS recovery)

    Time frame: Day 5

    In vivo skeletal muscle PCr-recovery expressed by PCr halftime (s)

  9. Muscle metabolism in vivo (H-MRS acetylcarnitine)

    Time frame: Day 5

    In vivo skeletal muscle acetylcarnitine concentrations in rest measured by H-MRS and expressed by mmol/kgww

  10. Muscle volume upper-leg

    Time frame: Day 5

    Muscle volume measured by MRI

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

  • Netherlands Organisation for Scientific Research
  • Top Institute Food and Nutrition

Registry information

Official study title

Mitochondrial Health and Muscle Function in Elderly

Acronym: ELMIH

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Sep 11, 2018
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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