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Muscle WeaknessELMIHNCT03666013

Mitochondria and Muscle Health in Elderly

An observational study of Muscle Weakness, run by Maastricht University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Weakness
How many people
59 participants
Where
1 siteNetherlands
Study dates
27 Jun 2017to 9 Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Healthy volunteers between 20 and 30 years old and 65 and 80 years old

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University

    Maastricht, Limburg, 6200 MD

Other trials in Netherlands

About this study

Official title: Mitochondrial Health and Muscle Function 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.

Read the 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.

Conditions
Muscle Weakness
Keywords
Mitochondrial health, Muscle function, Aging
Medical subject headings
Muscle Weakness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03666013
Study groupRoleWhat they receive
Young healthy subjects20-30 years old, max 1h of exercise per week
Elderly with a normal physical function65-80 years old, max 1h of exercise per week
Elderly with a decreased physical function65-80 years old, max 1h of exercise per week, SPPB under 9 or frailty score lower then 10
Active elderly65-80 years old, minimal 3h of exercise per week

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ex vivo mitochondrial State 3 respiration

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

    Measured: Day 4

Secondary outcomes (10)

  1. Insuline sensitivity

    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

    Measured: Day 1

  2. Physical functionality, 6MWT

    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

    Measured: Day 2

  3. VO2max

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

    Measured: Day 2

  4. Body composition

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

    Measured: Day 3

  5. Dynamic gait stability

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

    Measured: Day 3

  6. Muscle strength in upper-leg

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

    Measured: Day 3

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

    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)

    Measured: Day 4

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

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

    Measured: Day 5

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

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

    Measured: Day 5

  10. Muscle volume upper-leg

    Muscle volume measured by MRI

    Measured: Day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start27 Jun 2017
  3. Primary completion1 Oct 2019
  4. Study completion9 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03666013
Sponsor's protocol ID
Mitohealth
Acronym
ELMIH
Status last verified
Apr 2021
First submitted
4 Sep 2018
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mevenkamp J, Bruls YMH, Mancilla R, Grevendonk L, Wildberger JE, Brouwers K, Hesselink MKC, Schrauwen P, Hoeks J, Houtkooper RH, Buitinga M, de Graaf RA, Lindeboom L, Schrauwen-Hinderling VB. Development of a 31P magnetic resonance spectroscopy technique to quantify NADH and NAD+ at 3 T. Nat Commun. 2024 Oct 24;15(1):9159. doi: 10.1038/s41467-024-53292-4.

    PubMed 39443469

  • Mancilla R, Pava-Mejia D, van Polanen N, de Wit V, Bergman M, Grevendonk L, Jorgensen J, Kornips E, Hoeks J, Hesselink MKC, Schrauwen-Hinderling VB. Invasive and noninvasive markers of human skeletal muscle mitochondrial function. Physiol Rep. 2023 Jun;11(12):e15734. doi: 10.14814/phy2.15734.

    PubMed 37340318

  • Mancilla RF, Lindeboom L, Grevendonk L, Hoeks J, Koves TR, Muoio DM, Schrauwen P, Schrauwen-Hinderling V, Hesselink MK. Skeletal muscle mitochondrial inertia is associated with carnitine acetyltransferase activity and physical function in humans. JCI Insight. 2023 Jan 10;8(1):e163855. doi: 10.1172/jci.insight.163855.

    PubMed 36413408

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Weakness, run by Maastricht University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ex vivo mitochondrial State 3 respiration (time frame: Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03666013, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.

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