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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK126710-01 | 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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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.
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 - Meat | Experimental | A group of complementary foods provided to participants by researchers. |
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| Study Provided Diet - Plant | Experimental | A group of complementary foods provided to participants by researchers. |
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| Study Provided Diet - Dairy | Experimental | A group of complementary foods provided to participants by researchers. |
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| Traditional Diet | Placebo Comparator | No study foods provided to participants by researchers. Participants will eat a typical diet provided by caregivers. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baby Foods - Meat | Other | Commercially available baby foods |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | Measured in kg | Over 6 months |
| Length | Measured in cm | Over 6 months |
| Body composition | Body fat mass, fat-free mass measured by stable isotopes | Over 6 months |
| Gut Microbiome | Gut microbiota structure by 16S sequencing | Over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41763581 | Derived | Taren D, Matzeller K, Gilley SP, Hernandez M, Kemp JF, Armstrong M, Doenges K, Krebs NF, Tang M. Infant hyperglycemic excursions by saliva 1,5-anhydroglucitol varied by weight status, rapid weight gain, and mode of feeding: an exploratory secondary analysis. Am J Clin Nutr. 2026 May;123(5):101254. doi: 10.1016/j.ajcnut.2026.101254. Epub 2026 Feb 26. | |
| 35096709 | Derived | 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. |
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6 months intervention from ~5-12 months with follow-up assessments at 18 and 24 months.
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| Baby Foods - Dairy |
| Other |
Commercially available baby foods |
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| Baby Foods - Plant | Other | Commercially available baby foods |
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| Foods from the home | Other | Caregiver will provide participant with usual foods from the home |
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| 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 |
| 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 |
| Serum c-reactive protein (CRP-hs) | Measured in mg/L | Over 6 months |
| Plasma alpha 1-acid glycoprotein (AGP) | Measured in mg/L | Over 6 months |
| Dietary intake | 3 day dietary recall with results generated by NDSR software | Over 6 months |
| Food acceptance | Coded from behavioral observations and consumption measured in g | Over 6 months |