Mitochondrial oxidative stress and blood vessel health in young adults with early life adversity
Probing the Role of Mitochondrial Oxidative Stress in Impaired Vascular Function Among Young Adults With Early Life Adversity
We will test whether taking the mitochondrial antioxidant MitoQ can improve blood vessel function in healthy 18–29-year-olds who experienced significant adverse events in childhood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 29 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT07244809 on ClinicalTrials.gov |
What this trial studies
This interventional study randomizes healthy 18–29-year-old participants with an ACE score of 4 or higher to receive either mitoquinone mesylate (MitoQ) or a placebo. Participants have baseline and follow-up measures of endothelial function including flow-mediated dilation, blood-based mitochondrial and oxidative stress markers, and a standardized stress challenge (the Trier Social Stress Test). The goal is to see if targeting mitochondrial oxidative stress can reverse vascular endothelial dysfunction linked to early life adversity. Safety and eligibility screens exclude individuals with major cardiovascular risk factors, current tobacco or heavy alcohol use, recent drug use disorder, pregnancy, or regular antioxidant/NSAID use.
Who should consider this trial
Good fit: Healthy adults aged 18–29 with an ACE score of 4 or higher who are non-smokers, not pregnant or breastfeeding, and not taking cardiovascular/metabolic or vasoactive antidepressant medications.
Not a fit: Those with uncontrolled high blood pressure, BMI under 17 or over 35, current tobacco or heavy alcohol use, recent drug use disorder, regular vigorous exercise beyond the allowed threshold, or on excluded medications or antioxidant supplements are not eligible and would not be expected to benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a simple early intervention to improve blood vessel function and lower long-term cardiovascular risk in people who had significant childhood adversity.
How similar studies have performed: Preclinical studies and some small human trials of mitochondria-targeted antioxidants show promise for improving mitochondrial and vascular markers, but applying MitoQ to reverse ACE-related endothelial dysfunction in young adults is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-29 years * ACE score \>=4 Exclusion Criteria: * Resting arterial blood pressure \>140/90 mmHg * BMI \<=17 or \>= 35 * Are on a weight-loss diet or involved in a formal weight-loss program or are not intentionally weight stable for 6 months (+/- 5 kg) prior to the study. * Cardiovascular or metabolic prescription drug use * Vasoactive antidepressant drug use (SSRIs and clonidine) * Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition) * Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10) * Current tobacco or nicotine use * Vaping * Regular vigorous (\>6 METs) aerobic exercise (\>4 bouts/week, \>30 min/bout) * dietary supplementation with antioxidants or habitual use of NSAIDs * Currently pregnant or breastfeeding
Where this trial is running
Iowa City, Iowa
- Integrative Laboratory of Applied Physiology and Lifestyle Medicine — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Manoela Lima Oliveria, PhD
- Email: manoela-limaoliveira@uiowa.edu
- Phone: (319)467-3125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.