Anti-Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease

NCT02227602 | Completed DMC

• 1 other identifier: TexasAMU-IRB2013-0541F
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intestinal Diseases; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Simple Clinical Colitis Activity Index (SCCAI)

  * A questionnaire used to assess the severity of symptoms in people who suffer from ulcerative colitis * The score ranges from 0 to 19, where active disease is a score of 5 or higher * compare changes in the score during the study

  8 weeks

Secondary Outcomes (2)

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  8 weeks

• Biomarkers for inflammation : hs-CRP, Nf-kB, Il-6, Il-1b in Plasma (pg/ml)

  8 weeks

Study Arms (1)

Mango

EXPERIMENTAL

Mango polyphenolics

Drug: Mango polyphenolics

Interventions

Mango polyphenolics DRUG

Frozen mango pack will be provided (200\~400g per day).

Mango

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University, Clinical Lab, Nutrition and Food Science Department

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Intestinal Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Colonic Diseases

Study Officials

• Susanne Talcott, Ph.D

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nutition & Food Science

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: August 28, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: March 1, 2018
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

US (1)