Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation (MRI-AF)

Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial

This study is being done to see if the addition of mangosteen juice to standard medical care will reduce the risk of atrial fibrillation (AF) recurrence following direct current (DC) cardioversion. The study will also look at the effects the mangosteen juice may have on biomarkers of inflammation and endothelial cell dysfunction (the tissue lining the arteries does not function properly).

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: mangosteen juice; Drug: placebo juice

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Candidates for this study must meet all of the following criteria:

  • Age >18 years
  • Documented atrial fibrillation with a clinically indicated cardioversion.
  • Anticoagulation with therapeutic INR or PTT as per Mayo Clinic cardioversion guidelines.
  • Provision of written informed consent.

Exclusion Criteria:

• Subjects will be excluded if any of the following conditions apply:

  • Presence of atrial fibrillation secondary to a reversible cause such as thyrotoxicosis or alcohol use
  • Myocardial infarction within 1 month, CABG or cardiac surgery including surgical maze or AF radiofrequency ablation within the past 3 months
  • Presence of an implanted pacemaker, atrial defibrillator, or ventricular defibrillator
  • History of bleeding diathesis or coagulopathy
  • Known atrial thrombus or contra-indication to cardioversion
  • Active infection or collagen vascular disease with active inflammation
  • Current use of corticosteroids
  • Gastrointestinal (GI) or genitourinary bleed within the past six months requiring transfusion
  • Concomitant medical illness (i.e., cancer, congestive heart failure) that may preclude protocol compliance, confound data interpretation or limit life-expectancy to less than one year
  • Known allergy to juice components
  • Inability or refusal to cooperate with study procedures
  • Unsuccessful cardioversion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	6 months
attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).	6 months
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).	6 months
AF recurrence rates between the mangosteen group and the placebo group	6 months
Associated levels of inflammatory markers with those experiencing recurrent AF	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brent A Bauer, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 31, 2009
• First Submitted That Met QC Criteria: August 3, 2009
• First Posted (Estimate): August 4, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 07-007749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No