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Antioxidant Exercise Training for Mental Illness
N/A
Recruiting
Led By Ryan Garten, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to the end of the final visit, about 2 weeks
Awards & highlights
Summary
This trial will study how oxidants affect blood vessel function in people with and without mental health disorders.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects of antioxidants may include digestive discomforts such as nausea or diarrhea. Placebos typically have no active ingredients but can cause side effects based on participants' expectations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am generally healthy without any major heart, lung, or metabolic diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to the end of the final visit, about 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to the end of the final visit, about 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Arm Vascular Function at Rest (Flow Mediated Dilation Test)
Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)
Leg Vascular Function (Passive Leg Movement Test)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo then AntioxidantExperimental Treatment2 Interventions
Subjects will ingest a placebo prior to their second visit and an antioxidant cocktail prior to their third visit.
Group II: Antioxidant then PlaceboExperimental Treatment2 Interventions
Subjects will ingest an antioxidant cocktail prior to their second visit and a placebo prior to third second visit
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antioxidant
2014
N/A
~780
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,217 Total Patients Enrolled
Ryan Garten, PhDPrincipal InvestigatorVirginia Commonwealth University
5 Previous Clinical Trials
707 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am generally healthy without any major heart, lung, or metabolic diseases.You have been following a strict diet with very few calories or have low levels of vitamins and minerals in your body.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.I am on medication that affects my heart's function.I have recently quit smoking.You use illegal drugs or drink too much alcohol.For the healthy control group, you need to have a low score on two different mental health assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Antioxidant then Placebo
- Group 2: Placebo then Antioxidant
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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