Bioavailability and Pharmacokinetics of Mango

NCT03365739 | Completed

• 1 other identifier: IRB#2017-064
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of the study are:

1. 1.To investigate the relative bioavailability and absorption/kinetic profile of phytochemicals after acute consumption of mango pulp.
2. 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. 3.To enhance the bioavailability of polyphenols in mango pulp by addition of Vitamin C to the mango pulp.

Conditions

Healthy Subjects

Keywords

Mango; Mango pulp phytochemicals bioavailability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Characterization of polyphenolic compounds in plasma over 24 h in humans

  This will be conducted by using ultra-high performance liquid chromatography iFunnel quadrupole time of flight mass spectrometer (UHPLC-QTOF-MS) and triple quadrupole mass spectrometer (UHPLC-QQQ-MS).

  24 hr Postprandial

Secondary Outcomes (5)

• Characterization of Vitamin C in plasma over 24 h in humans

  24 hr Postprandial

• Characterization of beta carotene in plasma over 24 h in humans

  24 hr Postprandial

• the changes in the metabolite pool following chronic ingestion (14 days) of mango pulp

  Baseline vs 2 weeks

• the bioavailability (Cmax) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using Cmax.

  24 hr Postprandial

• the bioavailability (AUC) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using AUC.

  24 hr Postprandial

Study Arms (3)

Active Comparator 1

ACTIVE COMPARATOR

Treatment - Mango (pulp/flesh-500 g)

Dietary Supplement: Active Comparator 1

Active Comparator 2

ACTIVE COMPARATOR

Mango (500 g) + Vitamin C (100 mg)

Dietary Supplement: Active Comparator 2

Control Comparator

PLACEBO COMPARATOR

Vitamin C (100 mg)

Dietary Supplement: Control Comparator

Interventions

Active Comparator 1 DIETARY_SUPPLEMENT

Mango (pulp/flesh) (500 g)

Active Comparator 1

Active Comparator 2 DIETARY_SUPPLEMENT

Mango (500 g) + Vitamin C (100 mg)

Active Comparator 2

Control Comparator DIETARY_SUPPLEMENT

Vitamin C (100 mg)

Control Comparator

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: December 7, 2017
• Study Start: November 17, 2017
• Primary Completion: May 22, 2019
• Study Completion: May 31, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)