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Non-Pharmacologic Alternatives for Childhood Obesity

NCT03670875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-09-28

No results posted yet for this study

Summary

Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Animal models and clinical trials in adults have provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin, and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological alternatives could support diet and exercise to decrease the weight of children with obesity.

Conditions

  • Obesity in Childhood

Interventions

DIETARY_SUPPLEMENT

Agave inulin

Will be provided in dehydrated apple cubes

DIETARY_SUPPLEMENT

Curcumin

Will be provided in capsules

DIETARY_SUPPLEMENT

O3FA

Will be provided in capsules

BEHAVIORAL

Control

Dietary recommendations to ingest 1600 calories per day. Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)

Sponsors & Collaborators

  • Coordinación de Investigación en Salud, Mexico

    lead OTHER_GOV

Principal Investigators

  • Fernando Guerrero, PhD · Instituto Mexicano del Seguro Social

  • Gerardo Martinez, PhD · Instituto Mexicano del Seguro Social

  • Luis E Simental, PhD · Instituto Mexicano del Seguro Social

  • Claudia I Gamboa, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-31
Primary Completion
2022-10-31
Completion
2022-12-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03670875 on ClinicalTrials.gov