RECRUITING

The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall objective of this project is to understand how consuming a prescribed diet of different infant foods (which may contain cereals,fruits, vegetables, meats, dairy) during the time of early complementary feeding (\~5 to 12 months) in breastfed infants has on growth trajectories, neurodevelopment and sleep patterns in relation to gut microbiota, compared with a traditional diet that is usually provided in the home to infants. The three primary aims include: Aim 1: Identify the effects that the prescribed early complementary feeding specific study diet has on growth trajectories in breastfed infants. Aim 2: Identify whether the relationship between the prescribed early complementary feeding specific study diet and growth is mediated by gut microbiota. Aim 3: Characterize infant neurodevelopment and sleep patterns.

Official Title

The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health

Quick Facts

Study Start:2020-03-15
Study Completion:2023-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04137445

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Months to 6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Full term: gestational age \> 37 weeks
  2. * Exclusively breastfed (\< 2 weeks of cumulative formula exposure). Any formula consumption on a given day is considered one day of formula exposure. During the intervention, if the participant receives more than 50% of the liquid diet from infant formula, s/he will be excluded from the study.
  3. * Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.
  1. * Large for gestational age or small for gestational age
  2. * Antibiotic use from birth to the time of enrollment
  3. * Documented food allergies
  4. * Previous complementary food exposure
  5. * Conditions that would affect protein metabolism or growth

Contacts and Locations

Study Contact

Minghua Tang, PhD
CONTACT
303-724-3248
minghua.tang@cuanschutz.edu

Principal Investigator

Minghua Tang, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Minghua Tang, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-15
Study Completion Date2023-06

Study Record Updates

Study Start Date2020-03-15
Study Completion Date2023-06

Terms related to this study

Keywords Provided by Researchers

  • Complementary Feeding

Additional Relevant MeSH Terms

  • Linear Growth
  • Neurodevelopment
  • Gut Microbiome