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Mitochondria and Muscle Health in Elderly (ELMIH)

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ClinicalTrials.gov Identifier: NCT03666013
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Netherlands Organisation for Scientific Research
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University

Study Description
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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
Muscle Weakness

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
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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 : June 27, 2017
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : April 9, 2021
Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Urine, blood, muscle tissue

Eligibility Criteria
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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers between 20 and 30 years old and 65 and 80 years old
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666013


Locations
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Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University
Netherlands Organisation for Scientific Research
Top Institute Food and Nutrition
Investigators
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Principal Investigator: Patrick Schrauwen, Prof . dr. Maastricht University
More Information
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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT03666013    
Other Study ID Numbers: Mitohealth
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Mitochondrial health
Muscle function
Aging
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Pathologic Processes