Effect of Consuming a Mango and Chia-based Beverage on Mo... | NCT07529119

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

NCT07529119

Sponsor

Universidad Nacional de Caaguazu

Status

Recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Microbiota

Interventions

Mango juice
Mango and chia juice

Countries

Paraguay

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2026Actual

Primary Completion Date

May 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Feb 10, 2026

First Submission Date that Met QC Criteria

Apr 7, 2026

First Posted Date

Apr 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mango berverage	Experimental		Other: Mango juice
Mango and chia berverage	Active Comparator		Other: Mango and chia juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mango juice	Other	Mango juice drink for 6 weeks 200 ml daily, 5 days a week	Mango berverage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Allergyc to mango or chia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julieta Mendez, Msc	Contact	595985300046		julietamendez@unca.edu.py

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNCA	Recruiting	Coronel Oviedo			Paraguay

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

anonimyzed

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

When the study end

Access Criteria

Researchers

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C501277	Mangifera indica extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided