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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT04137445
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
100
1
2
38.5
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Baby Foods
  • Other: Foods from the home
N/A

Detailed Description

Some details are intentionally left to out to preserve the scientific integrity of the study, and they will be included in the record after the study is completed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
Actual Study Start Date :
Mar 15, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Provided Diet

A group of complementary foods provided to participants by researchers.

Other: Baby Foods
Commercially available baby foods

Placebo Comparator: Traditional Diet

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

Other: Foods from the home
Caregiver will provide participant with usual foods from the home

Outcome Measures

Primary Outcome Measures

  1. Weight [Over 6 months]

    Measured in kg

  2. Length [Over 6 months]

    Measured in cm

  3. Gut Microbiome [Over 6 months]

    Gut microbiota structure by 16S sequencing

Secondary Outcome Measures

  1. Neurodevelopment [At 12 months of age]

    Fine motor skills and cognition measured by the Bayley - III

  2. Duration of sleep [Over 6 months]

    Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph

  3. Body composition [Over 6 months]

    Body fat mass, fat-free mass measured by stable isotopes

  4. Serum c-reactive protein (CRP-hs) [Over 6 months]

    Measured in mg/L

  5. Serum IGF-1 (Insulin-like growth factor1/ somatomedin C) [Over 6 months]

    Measured in ng/mL

  6. Serum IGFBP-3 (Insulin-like growth factor-binding protein 3) [Over 6 months]

    Measured in ng/mL

  7. Dietary intake [Over 6 months]

    3 day dietary recall with results generated by NDSR software

  8. Total calories in breast milk [Over 6 months]

    Measured in kcal/100 mL

  9. Total carbohydrates in breast milk [Over 6 months]

    Measured in g/100 mL

  10. Total protein in breast milk [Over 6 months]

    Measured in g/100 mL

  11. Total fat in breast milk [Over 6 months]

    Measured in g/100 mL

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Months to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Minghua Tang, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT04137445
Other Study ID Numbers:
  • 19-0546
  • R01DK126710
First Posted:
Oct 24, 2019
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver

Study Results

No Results Posted as of Jun 11, 2021