Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption

NCT04726293 | Completed

• 1 other identifier: IRB-2020-57
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 low-grade inflammation.

Conditions

Overweight or Obesity; Healthy

Keywords

mango; Inflammatory markers; Gut microbiome; Metabolic responses

Outcome Measures

Primary Outcomes (9)

• 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

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  Baseline to 4 weeks

Secondary Outcomes (2)

• Characterize metabolite profiles after 4 week intake of mango beverage compared to a control beverage

  Baseline to 4 weeks

• Assess insulin sensitivity after 4 week intake of mango beverage compared to a control beverage

  Baseline to 4 weeks

Study Arms (2)

Mango beverage

EXPERIMENTAL

Mango composite served as a frozen drink

Dietary Supplement: Mango

Control beverage

PLACEBO COMPARATOR

Energy matched Control frozen drink

Dietary Supplement: Control

Interventions

Mango DIETARY_SUPPLEMENT

Mango beverage -1 cup fresh mango equivalent, twice a day for 4 weeks

Mango beverage

Control DIETARY_SUPPLEMENT

control beverage 1 cup, twice a day for 4 weeks

Control beverage

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

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 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
• 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

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Mangifera indica extract

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Indika v, Ph.D

  Illinois Insititute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: February 22, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 28, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)