Clinical trial NCT05012930: Effects of Complementary Feeding on Infant Growth and Gut Health
Official title: Effects of Complementary Feeding on Infant Growth and Gut Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gut Microbiome
Linear Growth
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-08-19
Enrollment: 267
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 months intervention from \~5-12 months with follow-up assessments at 18 and 24 months.
Primary purpose: BASIC_SCIENCE

Brief summary: This study plans to learn more about how consuming different foods during the time of early complementary feeding (\~5 to 12 months) affects growth and the development of bacteria living inside your baby's gut through school-age. The results from this study will potentially help to support future recommendations and dietary guidance for infant feeding practices.

The three primary aims include:

Aim 1. Identify the impact of dietary patterns with different protein-rich foods on infant growth.

Aim 2. Identify the impact of dietary patterns with different protein-rich foods on infant gut microbiota development.

Aim 3. Identify gut microbial taxa and genes that affect infant growth.

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.

Eligibility criteria: Inclusion Criteria:

* Full term;
* Generally healthy without conditions that would affect protein metabolism or growth
* No previous complementary food exposure
* Vaginal delivery
* No prior exposure of antibiotics during delivery or after birth
* Able to consume study foods
* Single birth.

Exclusion Criteria:

* Pre-term infants.
* Having conditions that would affect normal growth
* Had complementary foods prior to the start of the study
* Not willing to consume the complementary foods provided
* Antibiotics exposure during delivery or from birth to 5 months of life
* Multiple births

Primary outcomes:
measure: Weight
timeFrame: Over 6 months
measure: Length
timeFrame: Over 6 months
measure: Body composition
timeFrame: Over 6 months
measure: Gut Microbiome
timeFrame: Over 6 months
Secondary outcomes:
measure: Total calories in breast milk
timeFrame: Over 6 months
measure: Total carbohydrates in breast milk
timeFrame: Over 6 months
measure: Total protein in breast milk
timeFrame: Over 6 months
measure: Total fat in breast milk
timeFrame: Over 6 months
measure: Serum IGF-1 (Insulin-like growth factor1/ somatomedin C)
timeFrame: Over 6 months
measure: Serum IGFBP-3 (Insulin-like growth factor-binding protein 3)
timeFrame: Over 6 months
measure: Serum c-reactive protein (CRP-hs)
timeFrame: Over 6 months
measure: Plasma alpha 1-acid glycoprotein (AGP)
timeFrame: Over 6 months
measure: Dietary intake
timeFrame: Over 6 months
measure: Food acceptance
timeFrame: Over 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
References:
citation: Tang M, Matz KL, Berman LM, Davis KN, Melanson EL, Frank DN, Hendricks AE, Krebs NF. Effects of Complementary Feeding With Different Protein-Rich Foods on Infant Growth and Gut Health: Study Protocol. Front Pediatr. 2022 Jan 13;9:793215. doi: 10.3389/fped.2021.793215. eCollection 2021.