The Effects of Mango on Gut Health Markers

NCT07559604 | Not Yet Recruiting

• 1 other identifier: 5260012
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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)?
3. 3.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?
4. 4.Is LBP a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs?
5. 5.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?
6. 6.Is sCD14 a mediator of the relationship between insulin resistance \[as determined by HOMA-IR\] and SCFAs?

Conditions

Gut Health; LBP; sCD14; Short Chain Fatty Acids

Outcome Measures

Primary Outcomes (3)

• Lipopolysaccharide-binding protein (LBP)

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

  From baseline to the end of 8 months

• sCD14

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

  From baseline to the end of 8 months

• Short Chain Fatty Acids (SCFAs)

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

  From baseline to the end of 8 months

Study Arms (2)

Mango added to habitual diet

EXPERIMENTAL

In NCT06159543 participants were asked to consume 1.5 cups of mango per day for 12 weeks as part of their habitual diet.

Behavioral: Mango

Habitual diet without mango

NO INTERVENTION

In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet.

Interventions

Mango BEHAVIORAL

1.5 cups/day of mango for 12 weeks

Mango added to habitual diet

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participated in NCT06159543

You may not qualify if:

• Did not participate in NCT06159543

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

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

Loma Linda, California, 92350, United States

Location

MeSH Terms

Interventions

Mangifera indica extract

Study Officials

• Celine Heskey, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amandeep Wright, MPH

CONTACT

(909) 558-4300; amawright@llu.edu

Celine Heskey, DrPH

CONTACT

(909) 558-1000; cheskey@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)