Healthy SubjectsMGNCT03365739
Bioavailability and Pharmacokinetics of Mango
A study testing Active Comparator 1 and Active Comparator 2 in people with Healthy Subjects, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Active Comparator 1 and Active Comparator 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center
Chicago, Illinois, 60616
About this study
Official title: Bioavailability and Pharmacokinetic Parameters of Mango Pulp Phytochemicals in Human Plasma
The primary objectives of the study are:
- To investigate the relative bioavailability and absorption/kinetic profile of phytochemicals after acute consumption of mango pulp.
- 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.
- To enhance the bioavailability of polyphenols in mango pulp by addition of Vitamin C to the mango pulp.
Read the 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 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.
- Conditions
- Healthy Subjects
- Being tested
- Active Comparator 1, Active Comparator 2, Control Comparator
- Keywords
- Mango, Mango pulp phytochemicals bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator 1Dietary supplement
Mango (pulp/flesh) (500 g)
Active Comparator 2Dietary supplement
Mango (500 g) + Vitamin C (100 mg)
Control ComparatorDietary supplement
Vitamin C (100 mg)
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator 1 | Active comparator | Treatment - Mango (pulp/flesh-500 g) Receives: Dietary Supplement: Active Comparator 1 |
| Active Comparator 2 | Active comparator | Mango (500 g) + Vitamin C (100 mg) Receives: Dietary Supplement: Active Comparator 2 |
| Control Comparator | Placebo comparator | Vitamin C (100 mg) Receives: Dietary Supplement: Control Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hr Postprandial
Secondary outcomes (5)
Characterization of Vitamin C 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).
Measured: 24 hr Postprandial
Characterization of beta carotene 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).
Measured: 24 hr Postprandial
the changes in the metabolite pool following chronic ingestion (14 days) of mango pulp
Metabolites will be identified
Measured: Baseline vs 2 weeks
the bioavailability (Cmax) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using Cmax.
Cmax will calculated
Measured: 24 hr Postprandial
the bioavailability (AUC) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using AUC.
Area Under the Curve will be calculated
Measured: 24 hr Postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start17 Nov 2017
- Primary completion22 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Britt Burton-Freeman, Ph.D, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365739
- Sponsor's protocol ID
- IRB#2017-064
- Acronym
- MG
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Pharmacokinetic Parameters of Mango Pulp Phytochemicals in Human Plasma
- ClinicalTrials.gov ID
- NCT03365739
- Acronym / sponsor ID
- MG / IRB#2017-064
- Conditions
- Healthy Subjects
- Keywords
- Mango, Mango pulp phytochemicals bioavailability, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are:
- To investigate the relative bioavailability and absorption/kinetic profile of phytochemicals after acute consumption of mango pulp.
- 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.
- To enhance the bioavailability of polyphenols in mango pulp by addition of Vitamin C to the mango pulp.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator 1 | Active comparator | Dietary Supplement: Active Comparator 1Treatment - Mango (pulp/flesh-500 g) |
| Active Comparator 2 | Active comparator | Dietary Supplement: Active Comparator 2Mango (500 g) + Vitamin C (100 mg) |
| Control Comparator | Placebo comparator | Dietary Supplement: Control ComparatorVitamin C (100 mg) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator 1Mango (pulp/flesh) (500 g) | Dietary supplement | Active Comparator 1 |
| Active Comparator 2Mango (500 g) + Vitamin C (100 mg) | Dietary supplement | Active Comparator 2 |
| Control ComparatorVitamin C (100 mg) | Dietary supplement | Control Comparator |
Primary outcome
Characterization of polyphenolic compounds in plasma over 24 h in humans
Time frame: 24 hr Postprandial
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).
5 secondary outcomes
Characterization of Vitamin C in plasma over 24 h in humans
Time frame: 24 hr Postprandial
Characterization of beta carotene in plasma over 24 h in humans
Time frame: 24 hr Postprandial
the changes in the metabolite pool following chronic ingestion (14 days) of mango pulp
Time frame: Baseline vs 2 weeks
the bioavailability (Cmax) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using Cmax.
Time frame: 24 hr Postprandial
the bioavailability (AUC) of polyphenols in mango pulp by addition of Vitamin C to the mango pulp using AUC.
Time frame: 24 hr Postprandial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Britt Burton-Freeman, Ph.D principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator 1 and Active Comparator 2 in people with Healthy Subjects, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of polyphenolic compounds in plasma over 24 h in humans (time frame: 24 hr Postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.