NCT04137445

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

3.2 years

First QC Date

October 17, 2019

Last Update Submit

February 1, 2023

Conditions

Linear GrowthNeurodevelopmentGut Microbiome

Keywords

Complementary Feeding

Outcome Measures

Primary Outcomes (3)

  • Weight

    Measured in kg

    Over 6 months

  • Length

    Measured in cm

    Over 6 months

  • Gut Microbiome

    Gut microbiota structure by 16S sequencing

    Over 6 months

Secondary Outcomes (11)

  • Neurodevelopment

    At 12 months of age

  • Duration of sleep

    Over 6 months

  • Body composition

    Over 6 months

  • Serum c-reactive protein (CRP-hs)

    Over 6 months

  • Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)

    Over 6 months

  • +6 more secondary outcomes

Study Arms (2)

Study Provided Diet

EXPERIMENTAL

A group of complementary foods provided to participants by researchers.

Other: Baby Foods

Traditional Diet

PLACEBO COMPARATOR

No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers.

Other: Foods from the home

Interventions

Baby FoodsOTHER

Commercially available baby foods

Study Provided Diet
Foods from the homeOTHER

Caregiver will provide participant with usual foods from the home

Traditional Diet

Eligibility Criteria

Age5 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full term: gestational age \> 37 weeks
  • 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.
  • Maternal conditions such as gestational diabetes mellitus, preeclampsia, multiple pregnancies are acceptable.

You may not qualify if:

  • Large for gestational age or small for gestational age
  • Antibiotic use from birth to the time of enrollment
  • Documented food allergies
  • Previous complementary food exposure
  • Conditions that would affect protein metabolism or growth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

  • Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.

    PMID: 37506974DERIVED

MeSH Terms

Interventions

Infant Food

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Minghua Tang, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghua Tang, PhD

CONTACT

303-724-3248minghua.tang@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 24, 2019

Study Start

March 15, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)