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NCT Number: NCT07559604

The Effects of Mango on Gut Health Markers

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.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loma Linda, California, 92350, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participated in NCT06159543

Exclusion criteria

  • Did not participate in NCT06159543

Treatment and study plan

Mango

Behavioral

1.5 cups/day of mango for 12 weeks

Primary outcomes

  1. Lipopolysaccharide-binding protein (LBP)

    Time frame: From baseline to the end of 8 months

    Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.

  2. sCD14

    Time frame: From baseline to the end of 8 months

    sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.

  3. Short Chain Fatty Acids (SCFAs)

    Time frame: From baseline to the end of 8 months

    Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.

Study contacts

Contact information is provided by the study sponsor or research team.

Amandeep Wright, MPH

CONTACT

[email protected]

(909) 558-4300 ext. 47169

Celine Heskey, DrPH

CONTACT

[email protected]

(909) 558-1000 ext. 47181

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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