Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation (MRI-AF)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial|
- 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). [ Time Frame: 6 months ]
- attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs). [ Time Frame: 6 months ]
- Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c). [ Time Frame: 6 months ]
- Quality of life [ Time Frame: 6 months ]
- AF recurrence rates between the mangosteen group and the placebo group [ Time Frame: 6 months ]
- Associated levels of inflammatory markers with those experiencing recurrent AF [ Time Frame: 6 months ]
|Study Start Date:||July 2009|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: mangosteen juice
subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient
Drug: mangosteen juice
6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.
Other Name: Xango juice
Placebo Comparator: placebo juice
subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient
Drug: placebo juice
6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951301
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Principal Investigator:||Brent A Bauer, MD||Mayo Clinic|