Anti- Inflammatory Effects of Mango Polyphenolics in Inflammatory Bowel Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 4/2/2016 |
| Start Date: | January 2014 |
| End Date: | May 2016 |
| Contact: | Susanne Talcott, Phd |
| Email: | smtalcott@tamu.edu |
| Phone: | 9794581823 |
The Consumption of Mango Beverage Improves Biomarkers for Inflammation in Inflammatory Bowel Disease Patients
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.
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.
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.
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.
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.
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