NCT04726293

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mango	Mango beverage -1 cup fresh mango equivalent, twice a day for 4 weeks
DIETARY_SUPPLEMENT	Control	control beverage 1 cup, twice a day for 4 weeks

Timeline

• Start date: 2021-02-22
• Primary completion: 2023-03-31
• Completion: 2025-04-28
• First posted: 2021-01-27
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States