Overview

This trial is active, not recruiting.

Condition intestinal diseases
Treatments mango polyphenolics, sugary beverage
Sponsor Texas A&M University
Start date January 2014
End date May 2017
Trial size 90 participants
Trial identifier NCT02227602, TexasAMU-IRB2013-0541F

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Placebo Comparator)
sugary beverage
sugary beverage
15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.
(Experimental)
Mango polyphenolics
mango polyphenolics
Frozen mango pack will be provided (200~400g per day).

Primary Outcomes

Measure
Simple Clinical Colitis Activity Index (SCCAI): remission score of < 2.5 or improvement by at least 5 pts
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 72 years old.

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.

Additional Information

Official title The Consumption of Mango Beverage Improves Biomarkers for Inflammation in Inflammatory Bowel Disease Patients
Principal investigator Susanne Talcott, Ph.D
Description The clinical study will be designed as a randomized, controlled trial in subjects with mild-moderate active Crohn's disease (CD) or mild to moderate ulcerative colitis (UC). This study will be carried out in a randomized cross-over design with up to 8 weeks of mango or fiber treatment followed by a 4 week wash-out period and 8 weeks of the other treatment. Subjects with inflammatory bowel disease (IBD; CD or UC) will be recruited from patient records at the Ertan Digestive Disease Center and advertisement (letters, emails, flyers, newspapers). Additionally, patients may be recruited during standard of clinical care clinics: a) patients coming in for their regular, e.g. semi-annual or annual routine colonoscopy, b) UC or CD-related pain or symptoms, c) individuals presenting with diarrhoea that may be due to Crohn's disease or UC may also be recruited. Informed written consent will be obtained by the research personnel before the study begins. Approximately 90 individuals are expected to enroll in the study in order to obtain 60 subjects completing this study (considering screening failure and potential drop-outs). We expect a maximum of 90 subjects for the initial screening since many of these will be preselected from existing patient files. If subjects are scheduled for one of their regular check-up endoscopies, the results of the endoscopy will be used to assess the eligibility of subjects for participation in this study. This study is designed to incorporate standard of care routine exams as performed within the division of gastroenterology. During the initial screening, the inclusion criteria of patients will be assessed using the clinical indices. it will be performed a screening in which above listed inclusion criteria and hemoglobin, and exclusion parameters and height, weight, calculation of BMI in kg/ (height in meters)2, albumin and C-reactive protein will be assessed due to the high correlation to IBD-activity (>45 mg/L). Additionally, hematocrit (HcT), erythrocyte sedimentation, blood cell counts, vitamin D status (based on the association of IBD and Vitamin D deficiency. Subjects will be asked to give a stool sample that has to take place within 1 week before any endoscopic procedure is scheduled and laxatives are taken by the patients in preparation for the procedure. Fecal calprotectin fecal lactoferrin may be collected as standard of clinical care and this information will be used for this study. Study Treatments: A) Standard of clinical care + Fiber treatment (commercially available fiber product, equivalent to fiber contained in the mango treatment) B) Standard of clinical care + 200-400g of Mango b.i.d - t.i.d.,frozen or as smoothie. Subjects will be asked to record the exact amount consumed each day. Subjects who skip less than 1 day of mango consumption per week or less than 8 days over the entire period of 8 weeks of mango consumption will not be excluded from this study. Subjects will be randomized according to the statistician's guidelines into two groups that either start with study treatment A) or B). Subjects will consume their regular diet but reduce the intake of plant-based dietary supplements which contain secondary plant compounds such as resveratrol, quercetin, tannins, and also reduce their carbohydrate-derived energy by the same amount which is supplied through their mango consumption. Patients that are not receiving the mango will consume their regular diet, which will be controlled for basic nutrients contained in the mango treatment. The mango treatment will start either on this first study day, or as soon as subjects can be classified within the inclusion criteria. Subjects that underwent an endoscopy before the beginning of this study need to wait at least one week before the study treatment can be started. The study duration is 20 weeks, consisting of 8 weeks of treatment, 4 weeks of wash-out and another 8 weeks of the other treatment in a randomized crossover design.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Texas A&M University.