Physical Activity Oxidative Stress and Inflammation With Ageing

NCT06980896 | Not Yet Recruiting

• 1 other identifier: RC24_0365
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation; Oxydative Stress; Sarcopenia; Older Patient; Ageing

Keywords

inflammation; oxydative stress; sarcopenia; older patient; ageing

Outcome Measures

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).

  8 months

Secondary Outcomes (13)

• Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle strength in the included patients.

  8 months

• Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle power in the included patients.

  8 months

• Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle mass in the included patients.

  8 months

• Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and physical performance in the included patients.

  8 months

• Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and inflammatory biomarkers in the included patients.

  8 months

Study Arms (1)

slightly frail elderly, but excludes those with marked weight loss, low BMI

In this study, participants will undergo scheduled assessments, including blood tests, physical performance evaluations, and nutritional intake monitoring. Participants will be excluded from the study if they meet any of the following conditions: significant weight loss, defined as a reduction of more than 5% in one month or more than 10% in six months, Body Mass Index (BMI) below 22 kg/m², lifestyle and medical conditions that could interfere with study outcomes (smoking, diabetes, active cancer or cancer treatment within the past five years, chronic inflammatory diseases, recent infections or inflammatory episodes within the past month, long-term corticosteroid therapy or corticosteroid use within the last month, use of antioxidant supplements (including vitamins C and E, zinc, or selenium) within the past three monthscorticosteroid use within the last month, use of antioxidant supplements (including vitamins C and E, zinc or selenium) within the past three months

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting at the geriatric outpatient clinic in Nantes University Hospital (Nantes, France)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Tobacco consumption
• Diabetes
• Any type of active and/or treated cancer less than 5 years old
• Chronic inflammation pathology
• Clinically significant infectious or inflammatory episode ended at least one month ago
• Long-term or last-month corticosteroid therapy
• Antioxidants or trace elements taken in the last 3 months
• Patient not affiliated to a Social Security system
• Patient deprived of liberty by judicial or administrative decision
• Patients under guardianship or trusteeship

Sponsors & Collaborators

• Nantes University Hospital: lead
• Société KONDREE: collaborator
• Laboratoire PhyMedExp: collaborator
• CHU de Liège, Pr Pincemail: collaborator

Study Sites (1)

Dr Anthony Dylis

Nantes, Nantes, 44000, France

Location

MeSH Terms

Conditions

Inflammation; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Guillaume Chapelet, Dr

CONTACT

+33240686660; guillaume.chapelet@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Guillaume Chapelet

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)