Sign in

NCT04726293Completed

Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption

Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption in At-risk Overweight and Obese Population With Chronic Low-grade Inflammation

Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
22 Jan 2021
Start date
22 Feb 2021
Primary completion date
31 Mar 2023
Lead sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Diseases
Obesity
NCT number
NCT04726293

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 22 Feb 2021 to the primary completion date, 31 Mar 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Men and women with cancer other than non-melanoma skin cancer in previous 5 years
  • 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.
  • Men and women who have used antibiotics within the previous 2 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 who had substance (alcohol or drug) abuse within the last 2 years
  • Men and women who have unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months

Other illness

  • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
  • 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 diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
  • Men and women with history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional

Lab values

  • Men and women who have fasting blood glucose concentration \>125 mg/dL at screening visit

Other

  • Men and women who smoke
  • Men and women who have blood pressure \>160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating
  • Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
  • Men and women who had gastrointestinal barium opaque meal within 3 months
  • 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
  • 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)

Who the study is looking for

  • 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

Age in the registry: 20 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Nutrition Research Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.