ELMIH: Mitochondria and Muscle Health in Elderly

Sponsor
Maastricht University (Other)
Overall Status
Completed
CT.gov ID
NCT03666013
Collaborator
Netherlands Organisation for Scientific Research (Other), Top Institute Food and Nutrition (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Mitochondrial Health and Muscle Function in Elderly
    Actual Study Start Date :
    Jun 27, 2017
    Actual Primary Completion Date :
    Oct 1, 2019
    Actual Study Completion Date :
    Apr 9, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Young healthy subjects

    20-30 years old, max 1h of exercise per week

    Elderly with a normal physical function

    65-80 years old, max 1h of exercise per week

    Elderly with a decreased physical function

    65-80 years old, max 1h of exercise per week, SPPB under 9 or frailty score lower then 10

    Active elderly

    65-80 years old, minimal 3h of exercise per week

    Outcome Measures

    Primary Outcome Measures

    1. Rate of ex vivo mitochondrial State 3 respiration [Day 4]

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

    Secondary Outcome Measures

    1. Insuline sensitivity [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 [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 [Day 2]

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

    4. Body composition [Day 3]

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

    5. Dynamic gait stability [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 [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 [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) [Day 5]

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

    9. Muscle metabolism in vivo (H-MRS acetylcarnitine) [Day 5]

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

    10. Muscle volume upper-leg [Day 5]

      Muscle volume measured by MRI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maastricht University Maastricht Limburg Netherlands 6200 MD

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Patrick Schrauwen, Prof . dr., Maastricht University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maastricht University
    ClinicalTrials.gov Identifier:
    NCT03666013
    Other Study ID Numbers:
    • Mitohealth
    First Posted:
    Sep 11, 2018
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 20, 2021