Effect of Consuming a Mango and Chia-based Beverage on Modulating the Intestinal Microbiota in Obese Children

This randomized clinical trial evaluates the effect of a mango and chia-based beverage on gut microbiota modulation in 100 Paraguayan children aged 8-16 years with obesity. Participants will consume the intervention beverage for 6 weeks. Fecal samples will be collected before and after each intervention to analyze microbiota composition using 16S rRNA sequencing. This study aims to characterize the gut microbiota of Paraguayan children for the first time and assess whether this functional beverage can positively modulate intestinal bacteria as a potential strategy to address childhood obesity, which affects 1 in 3 school-age children in Paraguay.

Study Overview

• Status: Recruiting
• Conditions: Microbiota
• Intervention / Treatment: Other: Mango juice; Other: Mango and chia juice

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julieta Mendez, Msc; Phone Number: 595985300046; Email: julietamendez@unca.edu.py

Study Locations

• Paraguay
  • Coronel Oviedo, Paraguay
    • Recruiting
    • UNCA
    • Contact: Julieta Mendez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

100 children aged 8-16 years from Paraguay, stratified by BMI (with/without excess weight).

Exclusion Criteria:

Allergyc to mango or chia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mango berverage	Other: Mango juice; Mango juice drink for 6 weeks 200 ml daily, 5 days a week
Active Comparator: Mango and chia berverage	Other: Mango and chia juice; Mango and chia juice drink for 6 weeks, 200 ml daily 5 days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota	Gut microbiota composition analysis (16S rRNA sequencing)	Baseline and after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurements	Measure of weight	Baseline and after 4 weeks

Collaborators and Investigators

• Sponsor: Universidad Nacional de Caaguazu

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mangifera indica extract
• Other Study ID Numbers: PINV01-69

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonimyzed
• IPD Sharing Time Frame: When the study end
• IPD Sharing Access Criteria: Researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No