Bioavailability and Pharmacokinetics of Mango — MG  

Healthy Subjects Clinical Trial

Official title: Bioavailability and Pharmacokinetic Parameters of Mango Pulp Phytochemicals in Human Plasma

Status Completed

Clinical Trial 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 systemic accumulation or generation of new mango pulp phytochemicals /their metabolites in blood after regular mango intake for an extended time frame.

3. To enhance the bioavailability of polyphenols in mango pulp by addition of Vitamin C to the mango pulp.

Clinical Trial 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 treatments: Mango (pulp/flesh) (500 g), Mango (500 g) + Vitamin C (100 mg) or Vitamin C (100 mg) only. The study day visit will last for approximately 10.5 h with a follow up visit the next day (24 h) for blood and urine collection to allow for the characterization of target mango pulp phytochemicals and metabolites in plasma and urine. And then after a 2-week wash out period, a 14-day feeding trial will be conducted in which subjects will be given mango pulp (500 g) to take home and instructed to consume every day for 14 days, to study the accumulation of polyphenols and their metabolites in blood. A fasting blood sample will be collected on day 1 of the trial and then again on the 15th day.

Subjects will be required to meet several inclusion and exclusion criteria, which will be assessed through online survey and on-site clinic assessments, including questionnaires, blood analysis and anthropometric measures. Eligible subjects will be invited to participate in the study.

During the Screening Visit, subjects will read, sign and date a written Institutional Review Board approved Informed Consent Form prior to performing any study procedure. And then they will be assessed their qualification, if eligible to participate, subjects will be instructed on the process for completing study questionnaires and counseled to restrict intake of colored plant foods rich in phytonutrients the 7 days prior to each Study Day. They will be asked to restrict alcohol intake, coffee/tea/ caffeinated beverage intake and moderate / vigorous physical activity and to drink plenty of water to maintain hydration in the 24 h prior to each Study Day. They will be instructed to come to the Clinical Nutrition Research Center (CNRC) the day before each Study Day to pick up their dinner meal and evening snack. Subjects will be asked to get a usual night of sleep and to come to the CNRC after a 10-h overnight fasting on each Study Day.

Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 3, 4, 6, 7, 8, 9 10 and 24 hour (h) for assessment of change in plasma and metabolites. A drink will be provided immediately after the 0 h blood collection, a breakfast meal will be provided immediately after the 2 h blood collection, and lunch after 6 h blood collection. Urine samples will be collected at 0 (fasting)-2, 2-6, 6-10 and 24 h. ;

Related Conditions & MeSH terms

• Healthy Subjects

• NCT number: NCT03365739
• Study type: Interventional
• Source: Clinical Nutrition Research Center, Illinois Institute of Technology
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Completion date: May 31, 2020