Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption

Completed · Not applicable

Conditions studied: Overweight or Obesity, Healthy

In brief

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.

Key facts

Study ID: NCT04726293
Run by: Clinical Nutrition Research Center, Illinois Institute of Technology
People needed: 60
Starts: 2021-02-22
Expected to finish: 2025-04-28
Last updated by the study team: 2025-05-11

Who can join

Age: 20 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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
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)

Where it is running

Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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