NCT03666013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

September 4, 2018

Last Update Submit

April 19, 2021

Conditions

Muscle Weakness

Keywords

Mitochondrial healthMuscle functionAging

Outcome Measures

Primary Outcomes (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

    Day 4

Secondary Outcomes (10)

  • Insuline sensitivity

    Day 1

  • Physical functionality, 6MWT

    Day 2

  • VO2max

    Day 2

  • Body composition

    Day 3

  • Dynamic gait stability

    Day 3

  • +5 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers between 20 and 30 years old and 65 and 80 years old

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 39443469DERIVED

  • 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.

    PMID: 37340318DERIVED

  • 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.

    PMID: 36413408DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine, blood, muscle tissue

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Patrick Schrauwen, Prof . dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 11, 2018

Study Start

June 27, 2017

Primary Completion

October 1, 2019

Study Completion

April 9, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Locations

NL(1)