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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137445
Other study ID # 19-0546
Secondary ID R01DK126710
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2020
Est. completion date June 2023

Study information

Verified date February 2023
Source University of Colorado, Denver
Contact Minghua Tang, PhD
Phone 303-724-3248
Email minghua.tang@cuanschutz.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Months to 6 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Baby Foods
Commercially available baby foods
Foods from the home
Caregiver will provide participant with usual foods from the home

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Measured in kg Over 6 months
Primary Length Measured in cm Over 6 months
Primary Gut Microbiome Gut microbiota structure by 16S sequencing Over 6 months
Secondary Neurodevelopment Fine motor skills and cognition measured by the Bayley - III At 12 months of age
Secondary Duration of sleep Measured in minutes per 24 hours by the MicroMini-Motionlogger actigraph Over 6 months
Secondary Body composition Body fat mass, fat-free mass measured by stable isotopes Over 6 months
Secondary Serum c-reactive protein (CRP-hs) Measured in mg/L Over 6 months
Secondary Serum IGF-1 (Insulin-like growth factor1/ somatomedin C) Measured in ng/mL Over 6 months
Secondary Serum IGFBP-3 (Insulin-like growth factor-binding protein 3) Measured in ng/mL Over 6 months
Secondary Dietary intake 3 day dietary recall with results generated by NDSR software Over 6 months
Secondary Total calories in breast milk Measured in kcal/100 mL Over 6 months
Secondary Total carbohydrates in breast milk Measured in g/100 mL Over 6 months
Secondary Total protein in breast milk Measured in g/100 mL Over 6 months
Secondary Total fat in breast milk Measured in g/100 mL Over 6 months
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