Recruiting

Exercise with Acetyl-L-Carnitine

Sponsor:

NYU Langone Health

Code:

NCT07340281

Conditions

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Exercise Intervention

Study Details

Brief summary:

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.

Conditions

Anxiety Disorders

Study ID

NCT07340281

Start date

Mar 6, 2026

Status verified date

Mar, 2026

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Individuals with Anxiety Disorder

All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.

active comparator: Control Individuals

All participants will complete the 4-week exercise intervention in which they'll be prescribed 150 minutes of moderate intensity exercise per week at home, which will be measured using Fitbits.

Interventions

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 measure

  • Acetyl-L-carnitine (LAC) Levels [ Time Frame: Week 4 ]
  • Interleukin-6 (IL-6) Levels [ Time Frame: Week 4 ]

Central Contacts and Locations

Central contacts

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-31.