NCT07340281 · NYU Langone Health
Biomarkers for Exercise
What this study is about
The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine \[LAC\]) and inflammation (interleukin-6 \[IL-6\]) using innovative technology to isolate neuronal exosomes.
View original scientific description
The overarching objective is to examine the brain-based biological mechanistic pathway by which exercise exerts anxiolytic effects. The investigators will measure brain-derived markers of mitochondrial metabolism (acetyl-L-carnitine \[LAC\]) and inflammation (interleukin-6 \[IL-6\]) using innovative technology to isolate neuronal exosomes.
Interventions
BEHAVIORAL
Exercise Intervention
Exercise intervention is delivered in weekly individual sessions virtually for the 4-week intervention period. Sessions range from 25-45 minutes. The sessions serve as touch base points to review exercise for the week, plan for the coming week, problem-solve obstacles, and discuss various motivational strategies to help with an exercise routine. Participants are prescribed 150 minutes of moderate intensity exercise per week to be completed at home.
Primary outcome measures
Acetyl-L-carnitine (LAC) Levels
Time frame: Week 4
Levels of LAC isolated from neuronal exosomes from plasma blood draws.
Interleukin-6 (IL-6) Levels
Time frame: Week 4
Levels of IL-6 isolated from neuronal exosomes from plasma blood draws.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- For both participant groups: To be eligible to participate in this study, an individual must meet all of the following criteria:
- Between 18-50 years of age
- Currently sedentary (≤60 minutes of moderate intensity exercise per week for the past 3 months)
- Capable and willing to provide informed consent For anxiety disorder participant group, an individual must also meet: • Primary psychiatric diagnosis of generalized anxiety disorder (GAD), social anxiety disorder, or panic disorder
Exclusion criteria
- Lifetime history of Bipolar I or II or any psychotic disorder
- Bulimia or anorexia in the past 3 months
- Alcohol or substance use disorder in the past 3 months
- Current major depressive disorder (past is allowed)
- Current neurologic disorder
- High current suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the Columbia Suicide Severity Rating Scale (C-SSRS) consistent with a need for referral to higher level of care
- Participation in concurrent evidence-based therapy (e.g., cognitive behavioral therapy) targeting anxiety and/or depression (supportive therapy and couples therapy are allowed)
- Risk for exercise according to the Physical Activity Readiness Questionnaire with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures
- Women who are currently pregnant or plan to become pregnant during the duration of the study
- current psychiatric medication
- Current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the MINI structured diagnostic interview that it does not meet criteria for cannabis use disorder)
- Active infection Non-psychiatric controls who meet the following criteria will be excluded from participation in this study: • Current psychiatric condition assessed by the MINI
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations