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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK126710 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Provided Diet | Experimental | A group of complementary foods provided to participants by researchers. |
|
| Traditional Diet | Placebo Comparator | No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby Foods | Other | Commercially available baby foods |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minghua Tang, PhD | Contact | 303-724-3248 | minghua.tang@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Minghua Tang, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37506974 | Derived | Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26. |
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| ID | Term |
|---|---|
| D007225 | Infant Food |
| ID | Term |
|---|---|
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Foods from the home |
| Other |
Caregiver will provide participant with usual foods from the home |
|
| 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 |
| D019602 |
| Food and Beverages |