Status:
COMPLETED
Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease
Lead Sponsor:
Texas A&M University
Conditions:
Intestinal Diseases
Ulcerative Colitis
Eligibility:
All Genders
18-72 years
Phase:
NA
Brief Summary
Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not previously been compared with...
Detailed Description
Rationale and Significance : Bioactive compounds from mango are bioavailable and their anti-inflammatory efficacy has been demonstrated in animals and humans. However, the efficacy of mangoes has not ...
Eligibility Criteria
Inclusion
- Male or female ages 18-79 years (see Protection of Human Subjects)
- Treated with mesalamine or any mesalamine derivate, e.g.Asacol, Apriso, Asacol, Canasa, Lialda, Pentasa, Rowasa orally or rectally as standard of clinical care in the treatment of their symptoms for Inflammatory bowel disease
- Treated using biologic immune-modulators including but not limited to: Infliximab, Adalimumab, Certolizumab, Natalizumab, azathioprine.
- Additionally, patients may be on steroids (prednisone 10mg, budesonide 9mg)
- Subjects must have been on a stable drug-regiment for at least 3 weeks before study begin.
Exclusion
- history of acute cardiac event, stroke, or cancer, within the last 6 months,
- recurrent hospitalizations,
- drug treatment of any of the listed conditions within the last 6 months,
- abuse of alcohol or substance within the last 6 months,
- currently smoking more than 1 pack/week,
- seizures,
- liver or renal dysfunction,
- pregnancy or lactation,
- allergy against mangos,
- hepatitis B, C, or HIV,
- regular exercise (\>60 minutes, ≥ 5 times/wk), due to association of antioxidant and anti-inflammatory effects and moderate exercise.
- known lactose intolerance, gluten sensitivity, or celiac disease
- Patients that have upcoming Inflammatory bowel disease-related surgery and Inflammatory bowel disease -related intestinal stricture will also be excluded.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02227602
Start Date
January 1 2014
End Date
March 1 2018
Last Update
December 4 2019
Active Locations (1)
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1
Texas A&M University, Clinical Lab, Nutrition and Food Science Department
College Station, Texas, United States, 77843