MitoQ for Cardiovascular Impairment from Early Life Stress

(PROMISE Trial)

Overseen By Manoela Lima Oliveria, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Must not be taking: Cardiovascular drugs, SSRIs

Disqualifiers: Hypertension, Obesity, Alcohol, Drugs, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how early life stress affects heart health and whether the supplement MitoQ (mitoquinone mesylate) can help. MitoQ targets mitochondria, the cell's energy producers, to determine if it can reduce stress on the heart. Participants will take either MitoQ or a placebo to compare results. The trial seeks young adults who have faced significant early life stress and lack typical heart disease risk factors. Participants should have experienced many adverse childhood events but currently appear otherwise healthy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on heart health and stress.

Is there any evidence suggesting that MitoQ is likely to be safe for humans?

Previous studies have shown that Mitoquinone mesylate (MitoQ) is safe and well tolerated. Research on older adults found that MitoQ did not cause serious side effects. This antioxidant specifically targets the mitochondria, the parts of cells that provide energy. Other studies have shown that MitoQ can improve heart health and reduce cellular stress. While these findings are promising, results can vary, and not all effects are known yet. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cardiovascular impairment?

Mitoquinone mesylate (MitoQ) is unique because it targets oxidative stress at the cellular level, which is a different approach compared to most cardiovascular treatments that often focus on symptoms like high blood pressure or cholesterol. Unlike standard treatments for cardiovascular impairment, MitoQ is a mitochondria-targeted antioxidant, meaning it works by directly protecting the cell's powerhouse, potentially preventing damage from early life stress. Researchers are excited about MitoQ because it represents a novel approach that could address the root causes of cardiovascular issues rather than just managing symptoms.

What evidence suggests that MitoQ might be an effective treatment for cardiovascular impairment from early life stress?

Research has shown that Mitoquinone mesylate (MitoQ), which participants in this trial may receive, can improve blood vessel function. MitoQ, an antioxidant, protects cells from damage caused by oxidative stress, a harmful type of cellular stress. Studies have found that MitoQ guards against this stress and enhances blood vessel function. Specifically, taking MitoQ has improved the health of the blood vessel lining, which is crucial for heart health. This suggests that MitoQ might help lower heart-related risks for those who have faced stress early in life. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young adults who have had stressful experiences in childhood, such as abuse or neglect. Participants should be healthy without classic cardiovascular disease risk factors but may have impaired vascular function due to their past adversity.

Inclusion Criteria

I am between 18 and 29 years old.

ACE score greater than or equal to 4

Exclusion Criteria

Current heavy alcohol use as defined by 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 months) 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single acute dose of MitoQ or placebo, followed by vascular endothelial function assessment and psychosocial stress testing

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure and cortisol measurements

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitoquinone mesylate (MitoQ)

Trial Overview The study tests if a drug called Mitoquinone mesylate (MitoQ) can reduce mitochondrial oxidative stress and improve vascular function in these individuals. It's compared with a placebo to see if there's a real effect of the medication.

How Is the Trial Designed?

Group I: Mitoquinone Mesylate (MitoQ) Experimental Treatment 1 Intervention

Mitoquinone Mesylate (160 mg, single dose)

Group II: Placebo Placebo Group 1 Intervention

Matched placebo (microcrystalline cellulose and tapioca, 160 mg, single dose)

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

MitoQ Limited

Collaborator

Trials

1

Recruited

9+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07244809

Probing the Role of Mitochondrial Oxidative Stress in ... In this study, we will use an acute dose of a mitochondrial targeted antioxidant supplement (MitoQ; or placebo) to experimentally interrogate ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5866124/

MitoQ improves mitochondrial dysfunction in heart failure ... The main findings are that pressure overload-induced heart failure in rats decreased cardiac function in vivo that was not altered by MitoQ. However, we ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772976125001886

MitoQ Protects Against Oxidative Stress-Induced ... Our findings confirm the cytoprotective potential of MitoQ to limit oxidative stress-induced adverse mitochondrial remodelling and dysregulation.

4. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.117.10787

Chronic Supplementation With a Mitochondrial Antioxidant ... Our laboratory has shown that supplementation with the mitochondrial-targeted antioxidant MitoQ improves vascular endothelial function.

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2025.1506460/full

Overview of MitoQ on prevention and management ... The data extraction process was particularly focused on outcomes pertinent to metabolic health (mitochondrial function, oxidative stress, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5945293/

Chronic supplementation with a mitochondrial antioxidant ... Here, we demonstrate for the first time that supplementation with the mitochondria-targeted antioxidant MitoQ is safe and well tolerated in late MA/O adults, ...

7. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.109.130351

Mitochondria-Targeted Antioxidant MitoQ 10 Improves ... MitoQ 10 protects against the development of hypertension, improves endothelial function, and reduces cardiac hypertrophy in young stroke-prone spontaneously ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213231716301641

The mitochondria-targeted antioxidant MitoQ modulates ... Our findings support that the antioxidant MitoQ has an anti-inflammatory and antioxidant action in the leukocytes of T2D patients by decreasing ROS production.