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Childhood Obesity Microbiome Study

NCT04770311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-04-15

No results posted yet for this study

Summary

The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science.

Conditions

  • Pediatric Obesity

Interventions

BEHAVIORAL

Microbiome friendly diet

Families in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet.

Sponsors & Collaborators

Principal Investigators

  • Sarah Armstrong, MD · Duke department of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2021-11-20
Completion
2021-11-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04770311 on ClinicalTrials.gov