InflammationPOXI-AGEINGNCT06980896
Physical Activity Oxidative Stress and Inflammation With Ageing
An observational study of Inflammation and Oxydative Stress, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Inflammation, Oxydative Stress, Sarcopenia
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients consulting at the geriatric outpatient clinic in Nantes University Hospital (Nantes, France)
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Pathophysiological Study on the Association Between Physical Performance and Biomarkers of Oxidative Stress and Low-Grade Inflammation in Elderly Patients
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.
Read the 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.
- Conditions
- Inflammation, Oxydative Stress, Sarcopenia, Older Patient, Ageing
- Keywords
- inflammation, oxydative stress, sarcopenia, older patient, ageing
- Medical subject headings
- Inflammation, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Correlations between the biomarkers listed below and muscle strength, as evaluated for the primary outcome according to EWGSOP(2) recommendations.
Measured: 8 months
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.
Measured: 8 months
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).
Measured: 8 months
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.
Measured: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and inflammatory biomarkers 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 inflammatory biomarkers, including:
- HCYTOMAG-60K Panel: sCD40L, EGF, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GRO, IFN-α2, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12(p40), IL-12(p70), IL-13, IL-15, IL-17A, IP-10, MCP-1, MCP-3, MDC (CCL22), MIP-1α, MIP-1β, PDGF-AB/BB, RANTES, TGF-α, TNF-α, TNF-β, VEGF, Eotaxin/CCL11, PDGF-AA.
- Human Aging Magnetic Bead Panel 1 - Metabolism Multiplex Assay: CTACK (skin chemokines), FGF-21, GDF-15, IL-6, IL-10, IL-18, Leptin.
- Other markers: Fibrinogen, CRP.
Measured: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and the nutritional intake of 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 the following average nutritional intakes, estimated using GENI v9.6 software and the Phenol-Explorer database version 3.6 for polyphenols, based on a 3-day dietary record (2 non-consecutive weekdays and 1 weekend day), following the recommendations of the French National Institute for Prevention and Health Education (INPES)
Measured: 8 months
Investigate correlations between inflammation-related biomarkers and muscle strength in the included patients.
Correlations between inflammation-related biomarkers (cited in secondary outcome #5) and muscle strength, as evaluated for the primary outcome.
Measured: 8 months
Investigate correlations between inflammation-related biomarkers and muscle power in the included patients.
Correlations between inflammation-related biomarkers (cited in secondary outcome #5) and muscle power, as measured for secondary outcome #2.
Measured: 8 months
Investigate correlations between inflammation-related biomarkers and muscle mass in the included patients.
Correlations between inflammation-related biomarkers (cited in secondary outcome #5) and appendicular skeletal muscle mass (ASM), as evaluated for secondary outcome #3.
Measured: 8 months
Investigate correlations between inflammation-related biomarkers and physical performance in the included patients.
Correlations between inflammation-related biomarkers (cited in secondary outcome #5) and physical performance, as evaluated for secondary outcome #4.
Measured: 8 months
Investigate correlations between inflammation-related biomarkers and the nutritional intake of the included patients.
Correlations between inflammation-related biomarkers (cited in secondary outcome #5) and average nutritional intake, as estimated for secondary outcome #6.
Measured: 8 months
Investigate correlations between nutritional intake and physical performance in the included patients.
Correlations between estimated nutritional intake (secondary outcome #6) and physical performance (secondary outcome #4).
Measured: 8 months
Investigate correlations between muscle mass and physical performance in the included patients.
Correlations between estimated nutritional intake (secondary outcome #6) and physical performance (secondary outcome #4).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Société KONDREE, Laboratoire PhyMedExp, Centre Hospitalier Universitaire de Liege
- Responsible party
- Principal investigator, bp-prom-regl, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980896
- Sponsor's protocol ID
- RC24_0365
- Acronym
- POXI-AGEING
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pathophysiological Study on the Association Between Physical Performance and Biomarkers of Oxidative Stress and Low-Grade Inflammation in Elderly Patients
- ClinicalTrials.gov ID
- NCT06980896
- Acronym / sponsor ID
- POXI-AGEING / RC24_0365
- Conditions
- Inflammation, Oxydative Stress, Sarcopenia, Older Patient, Ageing
- Keywords
- inflammation, oxydative stress, sarcopenia, older patient, ageing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Société KONDREE, Laboratoire PhyMedExp, Centre Hospitalier Universitaire de Liege
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients consulting at the geriatric outpatient clinic in Nantes University Hospital (Nantes, France)
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlations between VitC/VitE and Cu/Zn ratios, selenium, and muscle strength
Time frame: 8 months
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).
13 secondary outcomes
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle strength in the included patients.
Time frame: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle power in the included patients.
Time frame: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and muscle mass in the included patients.
Time frame: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and physical performance in the included patients.
Time frame: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and inflammatory biomarkers in the included patients.
Time frame: 8 months
Investigate correlations between biomarkers involved directly or indirectly in the oxidative stress process and the nutritional intake of the included patients.
Time frame: 8 months
Investigate correlations between inflammation-related biomarkers and muscle strength in the included patients.
Time frame: 8 months
Investigate correlations between inflammation-related biomarkers and muscle power in the included patients.
Time frame: 8 months
Investigate correlations between inflammation-related biomarkers and muscle mass in the included patients.
Time frame: 8 months
Investigate correlations between inflammation-related biomarkers and physical performance in the included patients.
Time frame: 8 months
Investigate correlations between inflammation-related biomarkers and the nutritional intake of the included patients.
Time frame: 8 months
Investigate correlations between nutritional intake and physical performance in the included patients.
Time frame: 8 months
Investigate correlations between muscle mass and physical performance in the included patients.
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Oxydative Stress, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Chapelet, Dr (+33240686660, guillaume.chapelet@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between VitC/VitE and Cu/Zn ratios, selenium, and muscle strength (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.