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Dietary Supplement

Antioxidants + Nitroglycerin for Cardiovascular Health (NO-Stress Trial)

N/A
Waitlist Available
Led By Ryan Harris, PhD
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be lean, overweight, or obese with a BMI less than or equal to 39 kg/m2
Men and premenopausal women ages 18-40
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (2 hours)
Awards & highlights

NO-Stress Trial Summary

This trial will look at the effect of stress in early life on cardiovascular health later in life.

Who is the study for?
The NO-Stress trial is for men and premenopausal women aged 18-40, who are lean, overweight, or obese with a BMI of 39 or less. Participants must have records of their socioeconomic status during childhood. Those with cardiovascular and other major diseases, postmenopausal women, individuals with class 3 obesity (BMI over 40), or those on meds affecting blood vessel tone cannot join.Check my eligibility
What is being tested?
This study tests the effects of an antioxidant cocktail and a nitroglycerin spray under the tongue against a placebo in understanding how early life stress impacts heart health. It also involves taking small tissue samples to study changes at the cellular level.See study design
What are the potential side effects?
Possible side effects may include headaches from nitroglycerin use; discomfort or bruising at biopsy site; allergic reactions to antioxidants; dizziness or low blood pressure.

NO-Stress Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is 39 or less.
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I am a man or a premenopausal woman aged between 18 and 40.

NO-Stress Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (2 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (2 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute Change in Flow mediated dilation
Secondary outcome measures
Acute Change in Arterial Stiffness
Acute Change in Biomarkers of oxidative stress
Acute change in Flow mediated dilation

NO-Stress Trial Design

2Treatment groups
Experimental Treatment
Group I: BiopsyExperimental Treatment1 Intervention
Following an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography.
Group II: Antioxidant CocktailExperimental Treatment3 Interventions
Following an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antioxidant cocktail
2009
Completed Early Phase 1
~70

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,994 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,568 Total Patients Enrolled
Ryan Harris, PhDPrincipal InvestigatorAugusta University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Antioxidant cocktail (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT02115724 — N/A
Cardiovascular Disease Research Study Groups: Biopsy, Antioxidant Cocktail
Cardiovascular Disease Clinical Trial 2023: Antioxidant cocktail Highlights & Side Effects. Trial Name: NCT02115724 — N/A
Antioxidant cocktail (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02115724 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this experiment limited to those who haven't yet reached the age of 85?

"This trial is only open to those between the ages of 18 and 40. There are 28 studies for minors, and 385 trials designed specifically for patients over 65 years old."

Answered by AI

In what healthcare scenarios is an Antioxidant cocktail typically prescribed?

"Antioxidant cocktail is commonly utilised to treat myocardial infarction, as well as anal fissure, angina attacks and alleviating pain."

Answered by AI

Is there still room for enrolment in this research trial?

"Unfortunately, this clinical trial is currently not looking for participants. Its last update was made on July 18th 2022 and it first posted in April 1st 2014. However, if you are searching for other trials, there are presently 427 studies actively recruiting people with cardiovascular diseases as well as 6 trials involving an antioxidant cocktail."

Answered by AI

Am I qualified to partake in this experiment?

"To meet the eligibility criteria for this trial, potential participants must have cardiovascular diseases and be within their 18th to 40th year of life. In total, 74 individuals are being recruited."

Answered by AI

What is the maximum participant capacity of this trial?

"Unfortunately, this trial is presently not recruiting individuals. The listing on clinicaltrials.gov was initially posted April 1st 2014 and most recently updated July 18th 2022. If you are searching for other studies, 427 trials are actively seeking participants with cardiovascular diseases while 6 medical researches into an Antioxidant cocktail are currently admitting patients."

Answered by AI

Could you provide an overview of previous experiments conducted on the Antioxidant cocktail?

"Currently, 6 clinical trials are researching the efficacy of Antioxidant cocktail. None of these active trials have moved into Phase 3 yet; however, they can be found in 14 distinct medical centres across New york City."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)
Ryan Harris 2014. "Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02115724.
~4 spots leftby Dec 2024
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