The Effects of Mango on Gut Health Markers | NCT07559604

NCT07559604

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

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:

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)?
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:

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?
Is LBP a mediator of the relationship between insulin resistance [as determined by HOMA-IR] and SCFAs?
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?
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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Name	Type	Description	Arm Group Labels	Other Names
Mango	Behavioral	1.5 cups/day of mango for 12 weeks	Mango added to habitual diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Amandeep Wright, MPH	Contact	(909) 558-4300	47169	amawright@llu.edu
Celine Heskey, DrPH	Contact	(909) 558-1000	47181	cheskey@llu.edu

Name	Affiliation	Role
Celine Heskey, DrPH	Loma Linda University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Nutrition Research Center, School of Public Health, Loma Linda University		Loma Linda	California	92350	United States

Intervention Browse Module