Gut Microbiome Clinical Trial
Official title:
The Effects of Early Complementary Feeding on Growth, Neurodevelopment, Sleep and Gut Health
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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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