Atrial FibrillationPhase 1MRI-AFNCT00951301
Evaluate Use of Mangosteen Juice Added to Usual Care in Reducing Risk of Recurrent Atrial Fibrillation
A Phase 1 study testing mangosteen juice in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- mangosteen juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- mangosteen juice, placebo juice
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mangosteen juiceDrug
Also called Xango juice
6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation.
placebo juiceDrug
6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation.
| Study group | Role | What they receive |
|---|---|---|
| mangosteen juice | Active comparator | subjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient Receives: Drug: mangosteen juice |
| placebo juice | Placebo comparator | subjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient Receives: Drug: placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (5)
attenuation of markers of endothelial cell dysfunction including endothelial progenitor cell (EPCs).
Measured: 6 months
Clinical levels of anticoagulation (INR), digoxin, CBC, lipids, and glycosylated hemoglobin (Hgb A1c).
Measured: 6 months
Quality of life
Measured: 6 months
AF recurrence rates between the mangosteen group and the placebo group
Measured: 6 months
Associated levels of inflammatory markers with those experiencing recurrent AF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Significantly lower accrual rate than anticipated, time constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent A Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951301
- Sponsor's protocol ID
- 07-007749
- Acronym
- MRI-AF
- Status last verified
- Mar 2016
- First submitted
- 31 Jul 2009
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mangosteen Effects on Inflammatory Markers in Atrial Fibrillation Trial
- ClinicalTrials.gov ID
- NCT00951301
- Acronym / sponsor ID
- MRI-AF / 07-007749
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significantly lower accrual rate than anticipated, time constraints.
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mangosteen juice | Active comparator | Drug: mangosteen juicesubjects randomized 1:1 to this arm will receive juice containing the mangosteen ingredient |
| placebo juice | Placebo comparator | Drug: placebo juicesubjects randomized 1:1 to this arm will receive specially prepared juice not containing mangosteen ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates for this study must meet all of the following criteria:
Key exclusion criteria (13 listed)
- Subjects will be excluded if any of the following conditions apply:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mangosteen juiceAlso: Xango juice6 ounces of juice containing mangosteen taken twice daily, AM and PM, for 6 months duration of study participation. | Drug | mangosteen juice |
| placebo juice6 ounces of specially prepared juice not containing mangosteen taken twice daily, AM and PM, for 6 months duration of the study participation. | Drug | placebo juice |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Significantly lower accrual rate than anticipated, time constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mangosteen juice in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Significantly lower accrual rate than anticipated, time constraints.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.