Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 17 of 17

List	Outcome	Time frame	Description
Primary	Endothelial function	Change from baseline at 28 days	Brachial artery flow-mediated dilation, and EndoPAT™
Primary	Carotid artery compliance	Change from baseline at 28 days	Carotid artery compliance and beta stiffness index
Primary	Arterial stiffness	Change from baseline at 28 days	Pulse-wave velocity
Primary	Left ventricular diastolic function	Change from baseline at 28 days	Measured via Cardiac Echo
Secondary	NADPH oxidase	Change from baseline at 28 days	Oxidative stress marker measured in endothelial cells
Secondary	Nitrotyrosine	Change from baseline at 28 days	Measured in endothelial cells
Secondary	MnSOD	Change from baseline at 28 days	Mitochondrial superoxide dismutase measured in endothelial cells
Secondary	eNOS	Change from baseline at 28 days	Endothelial nitric oxide synthase (eNOS) measured in endothelial cell
Secondary	COX IV	Change from baseline at 28 days	Marker of mitochondrial function measured in PBMCs
Secondary	Mitochondrial RCR	Change from baseline at 28 days	Mitochondrial respiration measured via Oroboros O2K
Other	Supine blood pressure	Change from baseline at 28 days	On the cardiovascular testing days, supine blood pressure will be measured in triplicate.
Other	Body Composition	Baseline	Whole body and regional body composition will be determined using dual energy x-ray absorptiometry for subject characteristics and for the determination of fat-free mass for the AA dose preparation.
Other	Plasma Lipid Concentrations	Baseline	Plasma lipid concentrations, including total-cholesterol (C) and triglycerides (TG) will be determined at baseline. The rationale for making these measurements is for screening criteria, subject characteristics, and because they may correlate with CV function.
Other	Glucose Concentrations	Change from baseline at 28 days	Fasted glucose concentrations will be measured at screening and at each vascular test.
Other	Sex Hormones	Change from baseline at 28 days	Serum concentrations of total testosterone (T), estradiol, albumin, sex hormone binding globulin (SHBG), luteinizing hormone and follicle stimulating hormone will be measured to document changes in hormone concentrations and free T will be calculated using the known affinity constants of T for SHBG and for albumin. Additional measures of T will be measured after 60 days if testosterone has not returned to baseline. The 60 day plus measures are for safety.
Other	Endothelin-1 (ET-1)	Change from baseline at 28 days	Plasma ET-1 will be measured because it is a potent vasoconstrictor and has complex interactions with NO. Specifically, ET-1 synthesis is under tonic inhibition by NO.
Other	Physical Activity Levels	Change from baseline at 28 days	To document the habitual physical activity status at baseline and the last week of respective interventions, daily energy expenditure will be estimated using ActivPal monitors.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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