Status:
COMPLETED
Bioavailability and Pharmacokinetics of Mango
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Conditions:
Healthy Subjects
Eligibility:
All Genders
20-45 years
Phase:
NA
Brief Summary
The primary objectives of the study are: 1. To investigate the relative bioavailability and absorption/kinetic profile of phytochemicals after acute consumption of mango pulp. 2. To study the systemi...
Detailed Description
The trial is designed as a randomized, 3 arm, within-subject crossover, study design. Subjects meeting eligibility criteria will participate in 3 in-lab visits where they will receive 1 of 3 treatment...
Eligibility Criteria
Inclusion
- Men or women, 20-45 years of age with body mass index (BMI) in range from 20 to 25 kg/m2
- Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years)
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, gastrointestinal medications, antibiotics, anti-inflammatory drugs, dietary supplements including fiber supplements, prebiotics and probiotics, etc.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food intake and GI-tract questionnaire, sample collection procedures and study visit schedule)
Exclusion
- Men and women who smoke
- Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations \> 125 mg/dL
- Men and women who have uncontrolled blood pressure \>140 mmHg (systolic)/90 mmHg (diastolic)
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years
- Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
- Men and women who has participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
- Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans or vegetarian
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
- Substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumers (\> 5 cups/day)
- Currently eat \> 2 servings per day of mangoes
- Men and women who do excessive exercise regularly or athlete
- Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
- Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
- Unusual working hours i.e., working overnight (e.g. 3rd shift)
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03365739
Start Date
November 17 2017
End Date
May 31 2020
Last Update
July 14 2020
Active Locations (1)
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1
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616