The Effects of Mango on Gut Health Markers
The Effects of Fresh Mango Consumption on Gut Permeability Markers and Short Chain Fatty Acid Production in Individuals With Prediabetes
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amandeep Wright, MPH
- Numéro de téléphone: 47169 (909) 558-4300
- E-mail: amawright@llu.edu
Sauvegarde des contacts de l'étude
- Nom: Celine Heskey, DrPH
- Numéro de téléphone: 47181 (909) 558-1000
- E-mail: cheskey@llu.edu
Lieux d'étude
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California
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Loma Linda, California, États-Unis, 92350
- Nutrition Research Center, School of Public Health, Loma Linda University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Participated in NCT06159543
Exclusion Criteria:
- Did not participate in NCT06159543
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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1,5 tasse/jour de mangue pendant 12 semaines
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Aucune intervention: Habitual diet without mango
In NCT06159543 participants were asked to refrain consuming mangoes for 12 weeks while continuing their habitual diet.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Lipopolysaccharide-binding protein (LBP)
Délai: From baseline to the end of 8 months
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Lipopolysaccharide-binding protein (LBP) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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sCD14
Délai: From baseline to the end of 8 months
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sCD14 will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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Short Chain Fatty Acids (SCFAs)
Délai: From baseline to the end of 8 months
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Short Chain Fatty Acids (SCFAs) will be measured in fasting blood that was drawn at baseline and the end of each phase of NCT06159543.
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From baseline to the end of 8 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Celine Heskey, DrPH, Loma Linda University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5260012
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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