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Fasting, Exercise, and Diet to Activate Autophagy in Depression (AutoFast)

17 giugno 2026 aggiornato da: University of Zurich

Targeting Autophagy in Depression: Fasting, Exercise, Diet

Depression is a common mental health condition that affects millions of people worldwide and is a leading cause of disability. Although current treatments can be effective, many patients do not fully recover or experience long-term improvement. This study aims to better understand how lifestyle factors such as physical activity and diet-related processes may influence biological mechanisms that could be linked to depression.

The study focuses on a natural cellular process called autophagy, which helps cells remove damaged components and maintain healthy function. Autophagy is influenced by energy availability in the body and may be affected by behaviors such as physical exercise and caloric restriction. Early evidence suggests that changes in autophagy may also be linked to mood regulation and depression, but this relationship is not yet well understood in humans.

In this exploratory study, we will investigate how physical activity influences autophagy and related metabolic and molecular processes in healthy adults. We will also examine whether these effects differ between individuals with different body weight and fitness levels, and between women and men.

A total of approximately 120 healthy adults aged 18 to 40 years will participate. Participants will be divided into four groups based on sex and body weight (normal weight or overweight). Each participant will attend study visits at the University Hospital Zurich and perform a standardized cycling exercise test under medical supervision.

During the exercise test, participants will perform a graded cycling protocol that gradually increases in intensity until exhaustion. We will collect small blood samples from a vein and from a fingertip at several time points before, during, and after exercise. Saliva samples will also be collected to measure stress-related hormones. Additional measurements include heart rate, breathing parameters, oxygen consumption, and physical performance.

Blood and saliva samples will be analyzed using advanced laboratory techniques to study changes in metabolism, immune signaling, hormones, gene activity, and markers related to autophagy. These analyses will help identify biological pathways that are activated by exercise and may be relevant to brain health and depression.

Participants will undergo medical screening before inclusion to ensure safety. Individuals with certain medical conditions or factors that could interfere with the study results will not be included. Participation is voluntary, and participants may withdraw at any time without consequences.

The study involves minimal risks associated with blood sampling and intense physical exercise, which will be performed under close medical supervision. The expected benefit is improved scientific understanding of how lifestyle-related biological processes may be linked to mental health, which could support the development of new preventive or therapeutic strategies for depression in the future.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background and Rationale Depressive disorders are among the leading causes of disability worldwide and represent a major public health burden. Despite the availability of pharmacological and psychotherapeutic treatments, a substantial proportion of patients do not achieve full remission or experience relapse. Current antidepressant strategies primarily target monoaminergic systems and are often insufficient in addressing the biological heterogeneity of depression.

Emerging evidence suggests that metabolic regulation and cellular stress response pathways may play an important role in the pathophysiology of depression. In particular, associations between metabolic disorders (such as obesity and insulin resistance) and depressive symptoms indicate shared biological mechanisms. This has led to increasing interest in lifestyle-based interventions, including physical activity, dietary modification, and caloric restriction, as potential modulators of both metabolic and neuropsychiatric outcomes.

A central candidate mechanism linking metabolism and brain function is autophagy, a conserved cellular process responsible for the degradation and recycling of damaged proteins and organelles. Autophagy is tightly regulated by nutrient availability and energy status, primarily via the AMPK-mTOR signaling axis. It is activated under energy deprivation and suppressed under nutrient excess. Proper autophagic flux is essential for neuronal homeostasis, immune regulation, and cellular stress adaptation.

Preclinical and emerging clinical evidence suggests that impaired autophagy may be involved in psychiatric disorders, including depression. Furthermore, interventions such as physical exercise, caloric restriction, and certain pharmacological agents have been shown to modulate autophagy-related pathways. However, the direct measurement of autophagic flux in humans under physiological conditions remains methodologically challenging, and its relationship to exercise-induced metabolic and neurobiological changes is not fully understood.

This study aims to address this gap by investigating autophagy-related biological responses to acute physical exercise in humans using a multi-omics approach.

Objectives Primary Objective To investigate whether acute physical exercise induces measurable changes in autophagy-related pathways and associated metabolic, proteomic, transcriptomic, and hormonal markers in humans.

Secondary Objectives To characterize exercise-induced changes in systemic metabolism, inflammatory markers, and stress hormones.

To explore associations between fitness level, body mass index (BMI), and molecular responses to exercise.

To identify potential biomarkers of autophagy activation in peripheral blood and saliva.

To generate mechanistic hypotheses linking metabolic regulation, autophagy, and pathways relevant to mood disorders.

Study Design This is a single-center, exploratory human research study conducted at the University Hospital Zurich in collaboration with exercise physiology facilities.

The study uses a cross-sectional experimental design involving standardized acute exercise stimulation (cardiopulmonary exercise testing, CPET) combined with repeated biological sampling and multi-omics profiling.

Participants will be stratified into four groups based on sex and BMI:

Normal-weight women Normal-weight men Overweight women Overweight men All participants will perform a standardized incremental cycling exercise test under controlled laboratory conditions.

Study Population Approximately 120 healthy adults aged 18-40 years will be included. Participants will be selected based on predefined inclusion and exclusion criteria to ensure medical safety and reduce confounding variables such as chronic disease, medication use, psychiatric disorders, and hormonal influences (e.g., hormonal contraception or pregnancy in women).

Women will be tested during early follicular phase (cycle days 1-5) to minimize hormonal variability.

Study Procedures

Each participant will undergo:

  1. Screening and Baseline Assessment Informed consent Medical history and physical screening Assessment of inclusion/exclusion criteria Questionnaires assessing mood, anxiety, and physical activity Serological screening for HIV and hepatitis B/C
  2. Physiological Measurements (Pre-exercise) Body composition analysis (DXA) Lung function testing Baseline blood sampling Saliva sampling for cortisol
  3. Exercise Intervention (CPET) Participants will perform a standardized graded cycling exercise test on an electromagnetically braked ergometer.

The protocol includes:

15-minute warm-up phase at submaximal intensity Incremental ramp protocol until voluntary exhaustion

Continuous monitoring of:

Oxygen uptake (VO₂) Carbon dioxide production (VCO₂) Heart rate and ECG Blood pressure Respiratory exchange ratio

Key physiological thresholds will be determined:

Aerobic threshold Anaerobic threshold Respiratory compensation point 4. Biological Sampling

Repeated biological sampling will be performed at defined time points:

Rest (baseline) End of warm-up (aerobic phase) Peak exercise (maximal exertion) 10 minutes recovery 30 minutes recovery

Samples include:

Venous blood (PBMC isolation and plasma) Capillary blood microsamples (fingertip sampling devices) Saliva (cortisol analysis) Urine (pregnancy test in women) Total blood volume per participant will be approximately 320 mL across all time points.

Laboratory Analyses

Collected samples will be used for multi-layered molecular profiling:

  1. Autophagy-Related Analyses LC3B-II-based flux assays in PBMCs Ex vivo stimulation assays with lysosomal inhibition (chloroquine-based approach) Quantification of autophagy-related proteins (e.g., ATG family, ULK1 pathway components) Gene expression profiling of autophagy signaling pathways
  2. Metabolomics and Lipidomics Targeted and untargeted metabolomic profiling Energy substrates and oxidative stress markers Polyamine metabolism (e.g., spermidine-related pathways) Steroid hormone profiling via mass spectrometry
  3. Proteomics and Transcriptomics Plasma and PBMC proteomic profiling (untargeted and targeted) Phosphoproteomic analysis Single-cell or bulk RNA sequencing of immune cells
  4. Inflammatory and Immune Markers Cytokine quantification (e.g., IL-1β, IL-6, IL-10, TNF-α) Markers of immune activation and systemic inflammation
  5. Hormonal and Stress Response Measures Cortisol (saliva and plasma) Sex steroid hormones (e.g., estradiol, testosterone, progesterone) Hypothalamic-pituitary-adrenal (HPA) axis-related markers
  6. Genomic and Epigenetic Analyses DNA damage mapping (e.g., oxidative lesions, strand breaks) DNA methylation profiling (EPIC array) Gene regulation changes in response to exercise-induced stress

Tipo di studio

Interventistico

Iscrizione (Stimato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svizzera
    • Canton of Zurich
      • Zurich, Canton of Zurich, Svizzera, 8091
        • University Hospital Zurich
        • Contatto:
        • Investigatore principale:
          • Jens Stepan, MD, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • age: 18-40 years
  • BMI: between 18.5 and 24.9 kg/m2 (SG1/2) or BMI between 25.0 and 39.9 kg/m2 (SG3/4)
  • ability to understand the study procedure and give consent
  • Written informed consent
  • SG1 women: any fitness level
  • SG2 men: VO2max < 45 ml/kg/KG29,30
  • Available to conduct CPET on menstrual cycle days 1-5 (SG1/3)
  • No infection with HIV or Hepatitis B/C

Exclusion Criteria:

  • No infectious illness for at least two weeks prior to the test
  • No vitamin supplementation during the week prior to the performance test
  • SG3 and SG4: More than 1 hour moderate exercise per week
  • No use of hormonal contraceptives in the last 6 months before the onset of the study (SG1/3)
  • a clinically diagnosed menstrual disorder (e.g., polycystic ovarian syndrome or amenorrhea) (SG1/3)
  • having given birth within the 12 months before inclusion in the study (SG1/3)
  • pregnancy or breastfeeding (SG1/3)
  • premenstrual dysphoric disorder (PMDD) (SG1/3)
  • history of epileptic seizure
  • history of depression
  • history of manic or psychotic episode
  • existing/current eating disorders (bulimia nervosa, anorexia nervosa) within the past 5 years
  • inability to communicate adequately in speech
  • inability to follow instructions
  • regular use of medication other than thyroxine
  • alcohol consumption as equivalent doses of more than 12 g of pure alcohol per day on average for women and 24 g of pure alcohol per day for men
  • vegan diet
  • daily nicotine consumption
  • currently or history of (regular) consumption of illegal drugs within the last year
  • known diseases of the cardiovascular system
  • arterial hypertension above 160/90 mmHg at rest
  • known pulmonary diseases
  • arthritis and rheumatic diseases and conditions
  • hematologic diseases
  • bronchial asthma
  • surgery less than 4-6 months ago
  • orthopedic or other diseases (e.g. neurological) that preclude maximum load on the bicycle ergometer
  • anemia (<12.0 g/dl for women and <14.0 g/dl for men)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Healthy, normal weight women, regular menstrual cycle, no hormones, all fitness levels
Procedura: Performance test
Standardized CPET on a bicycle ergometer. Venous and capillary blood sampling at baseline (rest), end of aerobic warm-up phase (15 min), peak exercise (ramp-protocoll, 8-12 min), 10 minutes post-exercise, and 30 minutes post-exercise.
Sperimentale: Healthy normal weight men, recreational fitness level
Procedura: Performance test
Standardized CPET on a bicycle ergometer. Venous and capillary blood sampling at baseline (rest), end of aerobic warm-up phase (15 min), peak exercise (ramp-protocoll, 8-12 min), 10 minutes post-exercise, and 30 minutes post-exercise.
Sperimentale: Healthy, overweight women, regular menstrual cycle, no hormones, recreational fitness levels
Procedura: Performance test
Standardized CPET on a bicycle ergometer. Venous and capillary blood sampling at baseline (rest), end of aerobic warm-up phase (15 min), peak exercise (ramp-protocoll, 8-12 min), 10 minutes post-exercise, and 30 minutes post-exercise.
Sperimentale: Healthy, overweight men, regular menstrual cycle, no hormones, recreational fitness levels
Procedura: Performance test
Standardized CPET on a bicycle ergometer. Venous and capillary blood sampling at baseline (rest), end of aerobic warm-up phase (15 min), peak exercise (ramp-protocoll, 8-12 min), 10 minutes post-exercise, and 30 minutes post-exercise.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Autophagic Flux in Peripheral Blood Mononuclear Cells (PBMCs)
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise (single study day).
Assessment of autophagic flux in PBMCs using ex vivo lysosomal inhibition and quantification of autophagy-related proteins (e.g., LC3B-II) to evaluate exercise-induced activation of autophagy pathways.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise (single study day).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
PBMC Transcriptome
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide transcriptomic profiling of PBMCs using RNA sequencing to identify exercise-induced changes in gene expression and cellular signaling pathways.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
PBMC Proteome
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Untargeted proteomic analysis of PBMCs to characterize exercise-induced changes in protein abundance and biological pathways.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
PBMC Phosphoproteome
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Untargeted phosphoproteomic profiling of PBMCs to assess exercise-induced changes in intracellular signaling and protein phosphorylation.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Plasma Proteome
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Untargeted plasma proteomics to identify circulating proteins and pathways altered by acute physical exercise.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Targeted Plasma Metabolomics
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Quantification of metabolites involved in energy metabolism, autophagy regulation, oxidative stress, and exercise adaptation using targeted metabolomic approaches.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Untargeted Metabolomic Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Comprehensive metabolomic profiling to identify exercise-induced changes in metabolic pathways associated with autophagy, energy homeostasis, and stress responses.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Polyamine Concentrations
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Quantification of circulating polyamines and related metabolites, including spermidine-associated pathways implicated in autophagy regulation.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Steroid Hormone Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Measurement of circulating steroid hormones, including cortisol, cortisone, DHEA, DHEAS, progesterone, estradiol, testosterone, aldosterone, and related metabolites using mass spectrometry.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Inflammatory Marker Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Quantification of circulating inflammatory cytokines and immune mediators, including IL-1α, IL-4, IL-6, IL-10, IL-13, and TNF-α.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide DNA Oxidation Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide mapping of oxidative DNA lesions in PBMCs to assess exercise-induced oxidative stress and genomic responses.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide DNA Strand Break Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide assessment of DNA strand breaks in PBMCs to characterize genomic stress responses induced by acute exercise.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
DNA Methylation Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Genome-wide DNA methylation analysis to investigate exercise-induced epigenetic regulation and associations with transcriptional responses.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Extracellular Vesicle Profile
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Characterization of circulating extracellular vesicles and their molecular cargo as potential mediators of exercise-induced intercellular communication.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Cardiorespiratory Fitness (VO₂max)
Lasso di tempo: Measured during the exercise test on the study day.
Maximum oxygen uptake measured during cardiopulmonary exercise testing as an indicator of aerobic fitness and exercise capacity.
Measured during the exercise test on the study day.
Blood Lactate Concentration
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, and peak exercise.
Capillary blood lactate concentrations measured during exercise to assess metabolic responses and anaerobic metabolism.
Baseline (rest), end of aerobic warm-up phase, and peak exercise.
Body Composition
Lasso di tempo: Baseline assessment prior to exercise testing.
Assessment of body fat mass, lean mass, and bone mineral density using dual-energy X-ray absorptiometry (DXA).
Baseline assessment prior to exercise testing.
Depressive Symptoms (Beck Depression Inventory-II, BDI-II)
Lasso di tempo: Baseline (Visit 1, prior to exercise testin
Assessment of depressive symptom severity using the Beck Depression Inventory-II (BDI-II), a validated self-report questionnaire.
Baseline (Visit 1, prior to exercise testin
Anxiety Symptoms (State-Trait Anxiety Inventory, STAI)
Lasso di tempo: Baseline (Visit 1, prior to exercise testing).
Assessment of state and trait anxiety using the State-Trait Anxiety Inventory (STAI).
Baseline (Visit 1, prior to exercise testing).
Physical Activity Level (International Physical Activity Questionnaire, IPAQ)
Lasso di tempo: Baseline (Visit 1, prior to exercise testing).
Assessment of habitual physical activity and exercise behavior using the International Physical Activity Questionnaire (IPAQ).
Baseline (Visit 1, prior to exercise testing).
Positive and Negative Affect (PANAS)
Lasso di tempo: Immediately before exercise testing and 30 minutes after completion of exercise testing.
Assessment of positive and negative affective states using the Positive and Negative Affect Schedule (PANAS).
Immediately before exercise testing and 30 minutes after completion of exercise testing.
Mood States (Profile of Mood States, POMS)
Lasso di tempo: Immediately before exercise testing and 30 minutes after completion of exercise testing.
Assessment of transient mood states, including tension, depression, anger, vigor, fatigue, and confusion, using the Profile of Mood States (POMS).
Immediately before exercise testing and 30 minutes after completion of exercise testing.
Subjective Well-Being (Befindlichkeitsskalen, BF)
Lasso di tempo: Immediately before exercise testing and 30 minutes after completion of exercise testing.
Assessment of current subjective well-being and psychological state using the Befindlichkeitsskalen (BF).
Immediately before exercise testing and 30 minutes after completion of exercise testing.
Current Psychological State (Eigenzustandsskala, EZ)
Lasso di tempo: Immediately before exercise testing and 30 minutes after completion of exercise testing.
Assessment of participants' current psychological state using the Eigenzustandsskala (EZ).
Immediately before exercise testing and 30 minutes after completion of exercise testing.
Premenstrual Symptoms (PMS Questionnaire)
Lasso di tempo: Baseline (Visit 1, female participants only).
Assessment of menstrual cycle-related symptoms in female participants using a standardized Premenstrual Syndrome (PMS) questionnaire.
Baseline (Visit 1, female participants only).
Capillary Blood Microsampling
Lasso di tempo: Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.
Evaluation of two certified capillary blood microsampling systems (Mitra® device and Whatman® 903 Protein Saver cards) for the collection of capillary blood samples. Comparisons will assess sample quality, analytical performance, feasibility, and concordance of omics-based measurements obtained from microsamples across repeated exercise-associated sampling time points.
Baseline (rest), end of aerobic warm-up phase, peak exercise, 10 minutes post-exercise, and 30 minutes post-exercise.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Zurich

Collaboratori

University Hospital, Bonn
ETH Zurich

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

11 settembre 2026

Completamento primario (Stimato)

30 settembre 2029

Completamento dello studio (Stimato)

30 settembre 2029

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AF25

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data (IPD) underlying the results reported in publications may be shared with qualified researchers for scientific research purposes. Shared data may include demographic, physiological, questionnaire, laboratory, and multi-omics datasets collected as part of the study. The study protocol, statistical analysis plan, informed consent form, and data dictionary may also be made available.

Data will be available beginning 12 months after publication of the primary study results and for up to 10 years thereafter. Access will be granted upon reasonable request, following review and approval of a scientifically sound research proposal by the study investigators and sponsoring institution. Any data sharing will be subject to approval by the responsible ethics committee, where required, and compliance with applicable data protection regulations. Data sharing will further require execution of an appropriate data sharing or transfer agreement to ensure partici

Periodo di condivisione IPD

12 months after publication until 10 years after publication

Criteri di accesso alla condivisione IPD

Upon reasonable request and approval

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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