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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Linear Growth, Neurodevelopment, Gut Microbiome

Intervention / Treatment
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* Other: Baby Foods
* Other: Foods from the home


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Provided Diet<br>A group of complementary foods provided to participants by researchers. | Other: Baby Foods<br>* Commercially available baby foods<br>|
| Placebo Comparator: Traditional Diet<br>No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. | Other: Foods from the home<br>* Caregiver will provide participant with usual foods from the home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complementary Feeding