Clinical trial NCT06980896: Physical Activity Oxidative Stress and Inflammation With Ageing
Official title: Exploratory Pathophysiological Study on the Association Between Physical Performance and Biomarkers of Oxidative Stress and Low-Grade Inflammation in Elderly Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammation
Oxydative Stress
Sarcopenia
Older Patient
Ageing
Keywords: inflammation
oxydative stress
sarcopenia
older patient
ageing
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Société KONDREE
name: Laboratoire PhyMedExp
name: CHU de Liège, Pr Pincemail
First posted: 2025-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting at the geriatric outpatient clinic in Nantes University Hospital (Nantes, France)

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.

Detailed description: The POXI-Ageing study aims to explore the relationship between oxidative stress, chronic inflammation, and muscle function in older individuals. The research hypothesizes that these biological factors contribute to muscle deterioration, commonly associated with aging, and may play a role in ageing conditions like sarcopenia. This prospective, exploratory, single-center, non-controlled study study will be conducted in CHU de Nantes (a French University Hospital in Nantes, France), and will included 30 participants (15 men and 15 women) at the Centre Ambulatoire Nantais de Gérontologie Clinique (CANGC), the geriatric outpatient clinic. The study is planned to run for a total of 17 months, divided into three key phases, a recruitment phase of 12 months, a follow-up Phase (up to 3 months), and a results/statistical analysis phase of 2 month.

In this study, participants will undergo scheduled assessments, including blood tests, physical performance evaluations, and nutritional intake monitoring. To participate in the study, individuals must meet the following conditions: (i) be aged between 70 and 90 years, (ii) have a scheduled blood test within two months, (iii) have a Clinical Frailty Score (CFS) of 4 or lower (indicating mild frailty). 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 months.

Regarding g the cinlsuion process, and more in details, a presentation poster about the study will be placed in the waiting room of the outpatient clinic. Screening will be conducted during the patient's first visit to the day hospital at CANGC (V0), with an initial verification of inclusion and non-inclusion criteria. Only patients meeting these criteria and scheduled for other appointments/consultations at CANGC (up to 3 month), with a blood test indicated within the next two months, may be pre-included in the protocol. An oral explanation will be provided by the clinician during this V0 visit, along with the distribution of the information letter. Patients will have a reflection period and will be able to ask the doctor any questions if needed. Patients who express their willingness to participate and indicate their non-opposition to the study will be considered pre-included. They will then be contacted by phone approximately 20 days before visit V1, which corresponds to their median next routine care appointment, to remind them of the instructions to follow before the blood and urine sample collection. A re-evaluation of the inclusion and non-inclusion criteria will be conducted on the day of V1 before their official inclusion in the study. This step will precede the blood sampling, urine collection, and the specific physical tests and examinations required for the research.

The primary objective will be to describe and investigate correlations between oxidative stress biomarkers, inflammation biomarkers, and muscle strength in older patients. The primary outcome will be Vitamin C/Vitamin E ratio, Copper/Zinc ratio, Selenium levels, and muscle strength, measured using an hand grip strength test and a quadriceps isometric contraction strength test.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Correlations between VitC/VitE and Cu/Zn ratios, selenium, and muscle strength
timeFrame: 8 months
Secondary outcomes:
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle strength in the included patients.
timeFrame: 8 months
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle power in the included patients.
timeFrame: 8 months
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle mass in the included patients.
timeFrame: 8 months
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and physical performance in the included patients.
timeFrame: 8 months
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and inflammatory biomarkers in the included patients.
timeFrame: 8 months
measure: Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and the nutritional intake of the included patients.
timeFrame: 8 months
measure: Investigate correlations between inflammation-related biomarkers and muscle strength in the included patients.
timeFrame: 8 months
measure: Investigate correlations between inflammation-related biomarkers and muscle power in the included patients.
timeFrame: 8 months
measure: Investigate correlations between inflammation-related biomarkers and muscle mass in the included patients.
timeFrame: 8 months
measure: Investigate correlations between inflammation-related biomarkers and physical performance in the included patients.
timeFrame: 8 months
measure: Investigate correlations between inflammation-related biomarkers and the nutritional intake of the included patients.
timeFrame: 8 months
measure: Investigate correlations between nutritional intake and physical performance in the included patients.
timeFrame: 8 months
measure: Investigate correlations between muscle mass and physical performance in the included patients.
timeFrame: 8 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Dr Anthony Dylis
Study officials:
References: