Physical Activity Oxidative Stress and Inflammation With Ageing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-90
SponsorNantes University Hospital
About this trial
Sarcopenia, an age-related decline in muscle function, are thought to be influenced by oxidative stress and low-grade inflammation, resulting in significant muscle mass reduction and altered physical performance. Indeed, oxidative stress and chronic inflammation in older adults are key factors contributing to metabolic protein disturbances, DNA mutations, and skeletal muscle decline during aging. Additionally, reduced food intake can lead to malnutrition, exacerbating muscle protein loss, oxidative stress and chronic inflammation.
Recent research has shown that a nutritional intervention, i.e. antioxidant supplementation (e.g., vitamins C, E, zinc, selenium) can reduce muscle damage in Facioscapulohumeral Dystrophy (FSHD) by correcting mitochondrial dysfunction and inflammation with a beneficial effect on physical performance and have led to the development of a personalized antioxidant supplementation model, supported by clinical trials (NCT02622438).
Although antioxidant supplementation appears beneficial for FSHD patients, its effects on age-related muscle decline remain unclear. This study aims to explore correlation between oxidative stress, inflammation, nutritional status and physical performance in older individuals. The findings will help establish the physiological basis for a potential antioxidant therapy for age-related muscle deterioration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 70 to 90, consulting the Nantes CHU CANGC (Bellier Hospital) and who has an indication for a blood test scheduled as part of routine care within 4 months according to the clinician.
Clinical Frailty Scale (CFS) score less than or equal to 4 (i.e. threshold for identifying frail elderly people).
Disqualifiers
Opposition to participation in the study
Indication for emergency blood sampling in the city
Use of a wheelchair or with a proven disability
Criteria for undernutrition: weight loss of more than 5% in the last month or more than 10% in the last 6 months and/or BMI strictly less than 22 kg/m2.
Trial population
Patients consulting at the geriatric outpatient clinic in Nantes University Hospital (Nantes, France)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: slightly frail elderly, but excludes those with marked weight loss, low BMI
Trial outcomes
Primary outcomes
1
Correlations between VitC/VitE and Cu/Zn ratios, selenium, and muscle strength
Correlations between VitC/VitE and Cu/Zn ratios, selenium, and muscle strength assessed according to EWGSOP(2) recommendations: hand grip strength (in kg) measured using the Baseline® model 12-0286, and quadriceps strength (in kg, isometric contraction) measured using a testing bench coupled with Biopac exploitation software (MP SYSTEM, ACQKnowledge®: MP36 Pack BASIC with BSL4 Software).
Time frame
8 monthsSecondary outcomes
1
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle strength in the included patients.
Correlations between the biomarkers listed below and muscle strength, as evaluated for the primary outcome according to EWGSOP(2) recommendations.
Time frame
8 months2
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle power in the included patients.
Correlations between all biomarkers directly or indirectly involved in oxidative stress, cited in the primary outcome and in secondary outcome #1, and muscle power measured by the Five-Time Sit-to-Stand Test (FTSST) in seconds.
Time frame
8 months3
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle mass in the included patients.
Correlations between all biomarkers directly or indirectly involved in oxidative stress, cited in the primary outcome and in secondary outcome #1, and appendicular skeletal muscle mass (ASM), assessed by segmental bioimpedance using the BIACORPUS RX 4004M and BODYCOMP software in kg for upper and lower limbs, as well as the ASM index (ASMI = ASM/height²).
Time frame
8 months4
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and physical performance in the included patients.
Correlations between all biomarkers directly or indirectly involved in oxidative stress, cited in the primary outcome and in secondary outcome #1, and physical performance assessed according to EWGSOP(2) recommendations: Timed Up and Go (TUG) in seconds and 4-meter walking speed in m/s.
Time frame
8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
Société KONDREE
Collaborator
Laboratoire PhyMedExp
Collaborator
CHU de Liège, Pr Pincemail
Collaborator
Source ClinicalTrials.gov
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