Antioxidant Exercise Training for Mental Illness

Overseen By Ryan Garten, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Cardiovascular medications

Disqualifiers: Smoking, Drug use, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of exercise and antioxidant supplements on blood vessel health in individuals with PTSD, generalized anxiety disorder (GAD), or no mental health issues. Participants will receive either an antioxidant cocktail or a placebo (a pill with no active ingredients) before visits to assess effects on their blood vessels. It is suitable for those who are generally healthy, not on certain medications, and have either PTSD, GAD, or neither. As an unphased trial, this study allows participants to contribute to groundbreaking research on mental health and cardiovascular wellness.

Will I have to stop taking my current medications?

If you are taking medications that could affect heart and blood vessel function, you may need to stop them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that antioxidants may help people with mental health issues like anxiety and PTSD. Studies have found that antioxidant supplements might ease symptoms of depression and anxiety, suggesting they could be safe and helpful for mental health. Although specific side effects for this trial are not available, antioxidants are usually well-tolerated in other studies. Participants in past studies have not reported major side effects. For those considering joining a trial with antioxidants, current evidence suggests they are likely safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about antioxidant exercise training for mental illness because it combines physical activity with an antioxidant cocktail, offering a novel approach to improving mental health. Unlike traditional treatments like medication or therapy, this method introduces antioxidants, which may help reduce oxidative stress, a factor linked to mental health issues. The dual approach of exercise and antioxidants could address both physical and biochemical aspects of mental illness, potentially leading to more comprehensive benefits. This unique combination is what sets it apart and fuels optimism about its effectiveness.

What evidence suggests that this trial's treatments could be effective for mental illness?

Research has shown that antioxidants might help with mental health issues like PTSD and generalized anxiety disorder. Studies have found that antioxidant supplements can improve symptoms of depression and anxiety. Antioxidants such as β-carotene and vitamin C are particularly linked to better mental health in teenagers. Those who consume more antioxidants tend to have a lower risk of depression. This trial will evaluate the effects of antioxidants on mental health, with participants receiving either an antioxidant cocktail or a placebo in different sequences. Antioxidants might improve mental health by reducing damage caused by harmful molecules called free radicals. ^{1 2 3 6 7}

Who Is on the Research Team?

Ryan Garten, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults with mental health disorders like PTSD or GAD, who are otherwise healthy without heart, lung, or metabolic diseases. Participants must score ≥33 on the PCL-5 for PTSD or ≥10 on the GAD-7 scale (and <33 on PCL-5) for GAD. Healthy controls need scores ≤10 on GAD-7 and <33 on PCL-5. Those taking certain medications, recent smokers, drug users, pregnant women, and those with significant diet restrictions can't join.

Inclusion Criteria

I am generally healthy without any major heart, lung, or metabolic diseases.

If you are in the PTSD group, you need to score 33 or higher on the PCL-5 checklist.

For the GAD group, you have to score 10 or higher on the GAD-7 self-report scale and less than 33 on the PCL-5 checklist.

Exclusion Criteria

Limited English proficiency

You have been following a strict diet with very few calories or have low levels of vitamins and minerals in your body.

I am on medication that affects my heart's function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Initial Testing

Participants undergo initial testing to familiarize with study equipment and procedures, determine body measures, and perform a blood draw

< 1 hour

1 visit (in-person)

Treatment

Participants receive antioxidant or placebo pills and undergo vascular function tests

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in vascular function from baseline

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Antioxidant
• Exercise Training

Trial Overview

The study investigates how antioxidants affect blood vessel function in people with mental health issues compared to healthy individuals. It aims to understand if oxidants in the blood contribute to vascular problems. Participants will receive either an antioxidant supplement or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Placebo then Antioxidant Experimental Treatment 2 Interventions

Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.

Group II: Antioxidant then Placebo Experimental Treatment 2 Interventions

Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Exercise interventions have shown positive health outcomes for hospitalized patients with depression, based on a systematic review of eight studies, indicating that exercise can be beneficial in acute mental health settings.

However, the evidence for the effectiveness of exercise in hospitalized patients with schizophrenia, bipolar disorder, or anxiety disorders is limited, highlighting a need for more research to determine the best exercise approaches for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for mental illness: a systematic review of inpatient studies. Stanton, R., Happell, B.[2018]

Aerobic exercise, particularly treadmill walking and cycling, conducted in supervised group settings for 30 to 40 minutes, three times a week, is beneficial for individuals with schizophrenia or schizoaffective disorder, based on a systematic review of three randomized controlled trials.

The review found no reported adverse events, indicating that these exercise interventions are safe for this population, with programs typically lasting between 10 to 16 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the aerobic exercise program variables for people with schizophrenia. Stanton, R., Happell, B.[2018]

A 12-week resistance training program was found to be safe for schizophrenia patients and led to significant improvements in their level of functioning, as measured by the Global Assessment of Functioning Scale (GAF).

Although the resistance training did not show significant effects on health-related difficulties assessed by the WHO-DAS, the positive outcomes suggest that tailored resistance training could be beneficial for managing symptoms and improving quality of life in schizophrenia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training in patients with schizophrenia: Concept and proof of principle trial. Maurus, I., Mantel, C., Keller-Varady, K., et al.[2021]

Exercise and physical activity can help prevent or delay the onset of various mental disorders and provide therapeutic benefits for conditions like anxiety, depression, and substance use disorders, although more robust studies are needed.

The review highlights that while there are specific benefits of exercise for different mental health disorders, the exact mechanisms behind these effects involve a combination of metabolic, physiological, and psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and physical activity in mental disorders. Wolff, E., Gaudlitz, K., von Lindenberger, BL., et al.[2021]

Exercise and physical activity have been shown to prevent or delay the onset of various mental disorders and can provide therapeutic benefits, either alone or as a supplement to other treatments.

Despite the promising evidence for exercise interventions in mental health, there is a lack of controlled studies across most disorder groups, indicating a need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and physical activity in mental disorders: clinical and experimental evidence. Zschucke, E., Gaudlitz, K., Ströhle, A.[2021]

A 12-week exercise program significantly improved markers of oxidative stress and antioxidant levels in young men experiencing first-episode psychosis, with a 5.6% increase in peripheral glutathione compared to a 24.4% decrease in the control group.

Participants in the exercise group experienced reductions in positive and general psychopathology symptoms, while the control group saw an increase in negative symptoms, suggesting that exercise may be a beneficial intervention for managing early psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a protective mechanism against the negative effects of oxidative stress in first-episode psychosis: a biomarker-led study. Fisher, E., Wood, SJ., Elsworthy, RJ., et al.[2021]

Strenuous physical exercise can overwhelm the body's antioxidant defenses, leading to increased oxidative stress, even in highly fit individuals.

Submaximal long-duration exercise training can enhance antioxidant defenses, but combining regular physical activity with a diet rich in antioxidants is recommended for better protection against oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxidants and antioxidants in exercise. Sen, CK.[2017]

Patients with schizophrenia have a significantly higher prevalence of metabolic syndrome and cardiovascular diseases, leading to a reduced life expectancy of up to 20 years compared to the general population.

Regular physical activity, particularly high-intensity interval training, can improve metabolic syndrome parameters, cognitive deficits, and overall quality of life in schizophrenia patients, although more controlled trials are needed to establish effective exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Exercise on Metabolic Syndrome, Cardiorespiratory Fitness, and Symptoms in Schizophrenia Include Decreased Mortality. Schmitt, A., Maurus, I., Rossner, MJ., et al.[2020]

Aerobic exercise training significantly reduces negative symptoms of schizophrenia, as indicated by improvements in the Positive and Negative Syndrome Scale (PANSS) scores, while resistance training did not show significant effects on these symptoms.

Overall, participation in any form of exercise (aerobic, resistance, or combined) leads to improvements in health-related physical fitness indicators, including body mass index and oxygen consumption, highlighting the benefits of exercise for individuals living with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic, Resistance, and Combined Exercise Training on Psychiatric Symptom Severity and Related Health Measures in Adults Living With Schizophrenia: A Systematic Review and Meta-Analysis. Bredin, SSD., Kaufman, KL., Chow, MI., et al.[2022]

Individuals with severe mental illness have a significantly shorter life expectancy, losing 10 to 20 years compared to the general population, highlighting a critical public health issue.

There is a pressing need for clinical programs and research focused on the role of exercise in improving health outcomes for this population, as current integration of exercise into treatment plans is minimal despite its known benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on mortality rates of individuals with severe mental illness. Baron, DA., Mishrekar, A., Kazmi, S.[2022]

Physical exercise has been shown to significantly benefit individuals with severe mental illnesses like schizophrenia by improving cognitive functions, global functioning, and alleviating negative symptoms, while also promoting neurogenesis and angiogenesis.

Successful engagement in physical activity programs for those with mental illnesses is enhanced when the programs are enjoyable, promote personal choice, and provide social support, highlighting the need for better integration of mental health services with community exercise resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Schizophrenia spectrum disorders and physical exercise]. Makris, K., Kollias, K.[2021]

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