Mitochondria and Muscle Health in Elderly

Muscle Weakness Clinical Trial

— ELMIH  

Official title:

Mitochondrial Health and Muscle Function in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666013
• Other study ID #: Mitohealth
• Status: Completed
• Start date: June 27, 2017
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2021
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 9, 2021
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University	Netherlands Organisation for Scientific Research, Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Day 1
Secondary	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	Day 2
Secondary	VO2max	Maximal oxygen uptake measured by maximal cycling test (ml*kg-1*min-1)	Day 2
Secondary	Body composition	Measured by BodPod and expressed by percentages of fat mass (%)	Day 3
Secondary	Dynamic gait stability	Characterized by using the CAREN-system locomotion assessment and expressed by amount of steps necessary to regain normal walking pattern	Day 3
Secondary	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)	Day 3
Secondary	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)	Day 4
Secondary	Muscle oxidative capacity in vivo (PCr-MRS recovery)	In vivo skeletal muscle PCr-recovery expressed by PCr halftime (s)	Day 5
Secondary	Muscle metabolism in vivo (H-MRS acetylcarnitine)	In vivo skeletal muscle acetylcarnitine concentrations in rest measured by H-MRS and expressed by mmol/kgww	Day 5
Secondary	Muscle volume upper-leg	Muscle volume measured by MRI	Day 5