The Effects of Mango on Gut Health Markers

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT07559604
Status
Not Yet Recruiting

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Conditions

  • Gut Health
  • LBP
  • Short Chain Fatty Acids
  • sCD14

Eligibility Criteria

Sex
ALL
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Mango — BEHAVIORAL
    1.5 cups/day of mango for 12 weeks

Study Details

This is an ancillary study of NCT06159543, which was a clinical trial that examined the effect of a 12-week 1.5 cups daily mango crossover intervention on cardiometabolic outcomes in individuals with prediabetes, male and female, and 40-60 years of age. The goal of this ancillary study is to test the effect of the mango intervention on gut health markers in individuals with prediabetes. The main questions it aims to answer are: 1. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of gut permeability as measured by lipopolysaccharide-binding protein (LBP) and soluble CD14 (sCD14)? 2. What is the effect of 1.5 cups per day of fresh mango over 12 weeks on microbiome modulation as estimated by short chain fatty acids (SCFAs)? Secondarily: 1. Is LBP a mediator of the relationship between systemic inflammation \[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\] and SCFAs? 2. Is LBP a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs? 3. Is sCD14 a mediator of the relationship between systemic inflammation \[as determined by C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1)\] and SCFAs? 4. Is sCD14 a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs? Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in LBP, sCD14, and SCFAs. As noted, this is an ancillary study of NCT06159543. Fasting blood was collected at baseline, and at the end of each phase of NCT06159543. This blood will be used to analyze LBP, sCD14 and SCFAs. Fasting blood and insulin were analyzed in NCT06159543, and will used to calculate HOMA-IR in the ancillary study. C-reactive protein, E-selectin, intercellular adhesion molecule-1 (ICAM-1), and vascular cell adhesion molecule-1 (VCAM-1) will be analyzed NCT06159543.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
31 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Mango added to habitual diet
    In NCT06159543 participants were asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.
  • No Intervention: Habitual diet without mango
    In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet.

Primary Outcome Measure

Lipopolysaccharide-binding protein (LBP) [ Time Frame: From baseline to the end of 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nutrition Research Center, School of Public Health, Loma Linda UniversityLoma LindaCalifornia92350-

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Nutrition Research Center, School of Public Health, Loma Linda University· Loma Linda, CA

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