Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease

About this trial

Last updated 6 years ago

Study ID

TexasAMU-IRB2013-0541F

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 72 Years

All Sexes

Trial Timing

Ended 8 years ago

What is this trial about?

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 respect to mild inflammatory bowel disease. In order to justify future pharmacokinetic and pharmacodynamic analyses in human clinical trials, a pilot assessment to determine efficacy in preventing or resolving Inflammatory bowel disease is a necessary step. Therefore, in this aim we will determine the clinical relevance of mango as an adjuvant treatment to conventional therapy in Inflammatory bowel disease . The effects of mango with common drug treatment in mild-moderate Inflammatory bowel disease will be compared to the drug-treatment alone. If mango or any other polyphenolic-rich food could be identified as helpful in shortening or reducing severity of episodes of inflammatory bowel disease, the addition of polyphenolics to conventional drug treatment in Inflammatory bowel disease would have a significant impact on public health.

What are the participation requirements?

Inclusion Criteria

* 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 Criteria

* 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.