NCT07529119

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Feb 2026Jul 2026

Study Start

First participant enrolled

February 9, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 10, 2026

Last Update Submit

April 7, 2026

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

  • Microbiota

    Gut microbiota composition analysis (16S rRNA sequencing)

    Baseline and after 4 weeks

Secondary Outcomes (1)

  • Anthropometric measurements

    Baseline and after 4 weeks

Study Arms (2)

Mango berverage

EXPERIMENTAL
Other: Mango juice

Mango and chia berverage

ACTIVE COMPARATOR
Other: Mango and chia juice

Interventions

Mango and chia juiceOTHER

Mango and chia juice drink for 6 weeks, 200 ml daily 5 days a week

Mango and chia berverage
Mango juiceOTHER

Mango juice drink for 6 weeks 200 ml daily, 5 days a week

Mango berverage

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Allergyc to mango or chia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNCA

Coronel Oviedo, Paraguay

RECRUITING

MeSH Terms

Interventions

Mangifera indica extract

Central Study Contacts

Julieta Mendez, Msc

CONTACT

595985300046julietamendez@unca.edu.py

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

April 14, 2026

Study Start

February 9, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

anonimyzed

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
When the study end
Access Criteria
Researchers

Locations

PA(1)