Overweight or ObesityMG2NCT04726293
Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption
A study testing Mango in people with Overweight or Obesity and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial summary
The primary objective of this project is to provide new knowledge through a comprehensive set of analyses that investigate the complex interplay between regular mango intake, gut microbial structure/ function, mechanisms of inflammation and insulin sensitivity in over weight (OW)/obese (OB) human subjects with chronic… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity, Healthy
- What is being tested?
- Mango
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 28 Apr 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men or women, 20-60 years of age, inclusive with high sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, >1.0 and ≤10 ng/
- BMI ≥ 25 kg/m2
- Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years
- Judged to be in good health on the basis of the medical history ie., 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, anti-inflammatory drugs, dietary supplements, etc.
- Able to provide informed consent
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- Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and GI tract questionnaire, sample collection and study visit schedule)
- Able to maintain usual physical activity pattern
- Able to abstain from alcohol consumption and avoid vigorous physical activity for 24 hours prior to and during study visit
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 who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
- Men and women who have fasting blood glucose concentration >125 mg/dL at screening visit
- 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
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- 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
- Men and women who are 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 have participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
- Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
- Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
- Men and women who have used antibiotics within the previous 2 months
- Men and women who had gastrointestinal barium opaque meal within 3 months
- Men and women who used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
- Men and women with history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
- Men and women who had substance (alcohol or drug) abuse within the last 2 years
- Excessive coffee and tea consumers (> 4 cups/d)
- Men and women who have donated blood within last 3 months
- Men and women who do excessive exercise regularly or are an athlete
- Men and women who have 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
- Men and women who have 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: Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption in At-risk Overweight and Obese Population With Chronic Low-grade Inflammation
The primary objective of this project is to provide new knowledge through a comprehensive set of analyses that investigate the complex interplay between regular mango intake, gut microbial structure/ function, mechanisms of inflammation and insulin sensitivity in over weight (OW)/obese (OB) human subjects with chronic low-grade inflammation.
Read the detailed description
The proposed study is a randomized, 2-arm, parallel, placebo-controlled design Human participants (n=44) with BMI >25 and high sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, >1.0 and ≤10 ng/L will be recruited. Recruited subjects must meet all eligibility criteria, sign and date a written Institutional Review Board (IRB)-approved Informed Consent Form. Participants will be randomized into one of the two beverage intervention groups i.e., mango or control beverage.
Each subject will be asked to come for 1 Screening Visit, 1 pre-study, and 3 Test Day Visits (two of which will also include OGTT testing). The initial screening visit will provide subjects with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey related to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be provided to subjects, along with counseling by the study investigators, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 test treatments based on a randomization schedule.
The three main Test Day visits will occur at Day 0; baseline), Day 14 (mid-point), and Day 28 (end-point). Two of the Test Day Visits(Day0 and Day 28) will last about 2.5-3 h and involve blood pressure (BP) measurements, anthropometric (weight, waist circumference; body composition) assessment, and an oral glucose tolerance test (OGTT) will be performed. The Test Day Visit on Day 14 will last about 1-1.5 hours, and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle placed by a certified phlebotomist. Subjects will maintain daily food and GI-tract diary during the 4-week feeding trial. The diary will include questions about food intake and the condition of gastrointestinal tolerance and bowel function. Urine and fecal samples will be collected to monitor modifications occurring in the metabolites during the supplementation. .
- Conditions
- Overweight or Obesity, Healthy
- Being tested
- Mango, Control
- Keywords
- mango, Inflammatory markers, Gut microbiome, Metabolic responses
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MangoDietary supplement
Mango beverage -1 cup fresh mango equivalent, twice a day for 4 weeks
ControlDietary supplement
control beverage 1 cup, twice a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mango beverage | Experimental | Mango composite served as a frozen drink Receives: Dietary Supplement: Mango |
| Control beverage | Placebo comparator | Energy matched Control frozen drink Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize indices of systemic inflammation (IL-6) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim will include analysis of systemic markers of inflammation (IL-6) in plasma
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation mechanism of action after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim via Toll like receptor, Nuclear factor erythroid 2-related factor 2, and nuclear factor kappa-light-chain-enhancer of activated B cells (TLR/Nrf2/NF-κB) activation in Monocytes isolated from peripheral blood.
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation mechanism of action (Toll like receptor) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim via Toll-like receptor, activation in Monocytes isolated from peripheral blood.
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation mechanism of action (nuclear factor kappa-light-chain-enhancer of activated B cells ) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim via nuclear factor kappa-light-chain-enhancer of activated B cells activation in Monocytes isolated from peripheral blood.
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation mechanism of action (Nuclear factor erythroid 2-related factor 2) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim via (Nuclear factor erythroid 2-related factor 2 activation in Monocytes isolated from peripheral blood.
Measured: Baseline to 4 weeks
Characterize the gut microbiota in response to regular mango intake in OW/OB participants with chronic low grade inflammation.
Fecal samples will be collected with standard collection kits and stored at -80°C until analysis. Metagenomic and transcriptomic analyses will be performed
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation (hs-CRP) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim will include analysis of systemic markers of inflammation (hs-CRP) in plasma
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation (TNF-α) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim will include analysis of systemic markers of inflammation (TNF-α) in plasma
Measured: Baseline to 4 weeks
Characterize indices of systemic inflammation (MCP-1) after 4 week intake of mango beverage compared to a control beverage
Assessments to address this aim will include analysis of systemic markers of inflammation (MCP-1) in plasma
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Characterize metabolite profiles after 4 week intake of mango beverage compared to a control beverage
Polyphenolic metabolites (phenolic acids and derivatives components) will be identified and quantified in urine and plasma.Metabolites in samples will be identified and quantified using an Agilent 6550 iFunnel UHPLC-QTOF-MS and6460 UHPLC-QQQ-MS, respectively
Measured: Baseline to 4 weeks
Assess insulin sensitivity after 4 week intake of mango beverage compared to a control beverage
Insulin sensitivity assessment using oral glucose tolerance test (OGTT) method. Assessments to address this aim will include analysis of glucose and insulin concentration in plasma
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start22 Feb 2021
- Primary completion31 Mar 2023
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Indika v, Ph.D, Principal investigator, Illinois Insititute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726293
- Sponsor's protocol ID
- IRB-2020-57
- Acronym
- MG2
- Status last verified
- May 2025
- First submitted
- 22 Jan 2021
- Last updated
- 11 May 2025
- Results posted
- 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 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption in At-risk Overweight and Obese Population With Chronic Low-grade Inflammation
- ClinicalTrials.gov ID
- NCT04726293
- Acronym / sponsor ID
- MG2 / IRB-2020-57
- Conditions
- Overweight or Obesity, Healthy
- Keywords
- mango, Inflammatory markers, Gut microbiome, Metabolic responses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 27 Jan 2021 (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 objective of this project is to provide new knowledge through a comprehensive set of analyses that investigate the complex interplay between regular mango intake, gut microbial structure/ function, mechanisms of inflammation and insulin sensitivity in over weight (OW)/obese (OB) human subjects with chronic low-grade inflammation.
Detailed description
The proposed study is a randomized, 2-arm, parallel, placebo-controlled design Human participants (n=44) with BMI >25 and high sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, >1.0 and ≤10 ng/L will be recruited. Recruited subjects must meet all eligibility criteria, sign and date a written Institutional Review Board (IRB)-approved Informed Consent Form. Participants will be randomized into one of the two beverage intervention groups i.e., mango or control beverage.
Each subject will be asked to come for 1 Screening Visit, 1 pre-study, and 3 Test Day Visits (two of which will also include OGTT testing). The initial screening visit will provide subjects with their site-specific, IRB-approved informed consent document prior to the start of any study-related procedures. Subject eligibility will be determined through a high sensitivity C-Reactive Protein (hs-CRP) marker value, anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey related to general eating, health, mood and exercise habits.
Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit that involved blood/urine/fecal collection. Shopping lists and meal plans will be provided to subjects, along with counseling by the study investigators, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7-day wash-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 test treatments based on a randomization schedule.
The three main Test Day visits will occur at Day 0; baseline), Day 14 (mid-point), and Day 28 (end-point). Two of the Test Day Visits(Day0 and Day 28) will last about 2.5-3 h and involve blood pressure (BP) measurements, anthropometric (weight, waist circumference; body composition) assessment, and an oral glucose tolerance test (OGTT) will be performed. The Test Day Visit on Day 14 will last about 1-1.5 hours, and subjects will be required to remain at the Clinical Nutrition Research Center for the duration of the visit. Fasting blood samples will be collected via a butterfly needle placed by a certified phlebotomist. Subjects will maintain daily food and GI-tract diary during the 4-week feeding trial. The diary will include questions about food intake and the condition of gastrointestinal tolerance and bowel function. Urine and fecal samples will be collected to monitor modifications occurring in the metabolites during the supplementation. .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mango beverage | Experimental | Dietary Supplement: MangoMango composite served as a frozen drink |
| Control beverage | Placebo comparator | Dietary Supplement: ControlEnergy matched Control frozen drink |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men or women, 20-60 years of age, inclusive with high sensitivity C-Reactive Protein (hs-CRP), a global marker of inflammation, >1.0 and ≤10 ng/
- BMI ≥ 25 kg/m2
- Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years
- Judged to be in good health on the basis of the medical history ie., 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, anti-inflammatory drugs, dietary supplements, etc.
Key exclusion criteria (24 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 who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
- Men and women who have fasting blood glucose concentration >125 mg/dL at screening visit
- 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
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 |
|---|---|---|
| MangoMango beverage -1 cup fresh mango equivalent, twice a day for 4 weeks | Dietary supplement | Mango beverage |
| Controlcontrol beverage 1 cup, twice a day for 4 weeks | Dietary supplement | Control beverage |
Primary outcome
Characterize indices of systemic inflammation (IL-6) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim will include analysis of systemic markers of inflammation (IL-6) in plasma
Characterize indices of systemic inflammation mechanism of action after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim via Toll like receptor, Nuclear factor erythroid 2-related factor 2, and nuclear factor kappa-light-chain-enhancer of activated B cells (TLR/Nrf2/NF-κB) activation in Monocytes isolated from peripheral blood.
Characterize indices of systemic inflammation mechanism of action (Toll like receptor) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim via Toll-like receptor, activation in Monocytes isolated from peripheral blood.
Characterize indices of systemic inflammation mechanism of action (nuclear factor kappa-light-chain-enhancer of activated B cells ) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim via nuclear factor kappa-light-chain-enhancer of activated B cells activation in Monocytes isolated from peripheral blood.
Characterize indices of systemic inflammation mechanism of action (Nuclear factor erythroid 2-related factor 2) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim via (Nuclear factor erythroid 2-related factor 2 activation in Monocytes isolated from peripheral blood.
Characterize the gut microbiota in response to regular mango intake in OW/OB participants with chronic low grade inflammation.
Time frame: Baseline to 4 weeks
Fecal samples will be collected with standard collection kits and stored at -80°C until analysis. Metagenomic and transcriptomic analyses will be performed
Characterize indices of systemic inflammation (hs-CRP) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim will include analysis of systemic markers of inflammation (hs-CRP) in plasma
Characterize indices of systemic inflammation (TNF-α) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim will include analysis of systemic markers of inflammation (TNF-α) in plasma
Characterize indices of systemic inflammation (MCP-1) after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assessments to address this aim will include analysis of systemic markers of inflammation (MCP-1) in plasma
2 secondary outcomes
Characterize metabolite profiles after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
Assess insulin sensitivity after 4 week intake of mango beverage compared to a control beverage
Time frame: Baseline to 4 weeks
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 11 May 2025.
- 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.
Indika v, Ph.D principal investigator
Illinois Insititute 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 Mango in people with Overweight or Obesity and Healthy, 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 9 inclusion and 24 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 11 May 2025. 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?
Characterize indices of systemic inflammation (IL-6) after 4 week intake of mango beverage compared to a control beverage (time frame: Baseline to 4 weeks). The study lists 9 primary outcomes in all. 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 11 May 2025.