Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial is a study designed
to test the primary hypothesis that a dietary supplement (Mangosteen) containing
anti-inflammatory and anti-oxidant properties may effect the measured levels of inflammatory
biomarkers. Secondarily, this study will compare the attenuation of markers of endothelial
cell dysfunction including endothelial progenitor cells (EPCs), clinical levels of
anticoagulation (INR), digoxin, lipids, and glycosylated hemoglobin (Hgb A1c), quality of
life measurements, AF recurrences, and associated levels of inflammatory markers with those
experiencing recurrent AF between the mangosteen group and the placebo group.
This trial will randomize 250 patients presenting to the Mayo Clinic Cardioversion Unit over
one year to two groups including a mangosteen supplemented group versus a control group with
placebo juice. Patients will be enrolled who have a history of paroxysmal, persistent, or
longstanding persistent atrial fibrillation and excluded if they have a history of recent
surgery, myocardial infarction, infection, collagen vascular disease with active
inflammation, or thyroid disease. Furthermore, patients already on corticosteroids will be
excluded. Patients will be evaluated at enrollment and followed at 3 months and 6 months
with repeat ECG, laboratory testing of inflammatory biomarkers and endothelial function, as
well as quality of life questions.
The trial will track the effect of natural juices containing anti-inflammatory and
anti-oxidant properties on inflammatory markers, endothelial progenitor cells, and quality
of life. This trial will attempt to determine if any dietary supplement effects to
inflammatory markers correlate with the rate of recurrent AF in each of the two groups.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Test the hypothesis that the addition of mangosteen juice as a dietary supplement may reduce the measured levels of inflammatory biomarkers interleukin 1, interleukin 6, C-reactive protein (CRP), and tumor necrosis factor alpha (TNF a) etc).
Brent A Bauer, MD
United States: Food and Drug Administration
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