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| Name | Class |
|---|---|
| Junlebao Dairy Group Co., Ltd. | INDUSTRY |
| Sprim Advanced Life Sciences | OTHER |
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The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary objective is to compare the growth, tolerance, stool consistency and bone strength of infants randomized to the study infant formula (SF) versus infants randomized to the standard commercial infant formula (CF).
This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a study infant formula, formulated for healthy term infants or a commercially available infant formula for healthy term infants. Infants will consume the formula for a total of 16-weeks; infant growth, tolerance, stool consistency and bone strength will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Formula | Experimental | a Cow's Milk Based Infant Formula Containing Both OPO and CPP for term infants (JunLeBao ZhiZhen) |
|
| Comparator Formula | Active Comparator | Commercially available infant formula without OPO for term infants (JunLeBao LeChun) |
|
| Human Milk Reference Group | No Intervention | Human milk |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Formula | Other | Study infant formula for term infants containing OPO and CPP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool characteristics | Infant Stool Form Scale to measure stool consistency, amount and color (Bekkali et al, 2009): 4-point scale as watery (A) soft (B) formed (C) or hard (D) | 1 month to 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Formula intake and tolerance (24 hour dietary recall) | ml /day | 2 months to 5 months |
| Medically-diagnosed adverse events collected throughout the study period | frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoyang Shen, MD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JiangNan Street Community Health Service Center, WuCheng District | Jinhua | China | ||||
| QiuBin Street Community Health Service Center, WuCheng District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39206307 | Derived | Sheng XY, Mi W, Yuan QB, Liu BY, Carnielli V, Ning YB, Einerhand AWC. An A2 beta-casein infant formula with high sn-2 palmitate and casein phosphopeptides supports adequate growth, improved stool consistency, and bone strength in healthy, term Chinese infants: a randomized, double-blind, controlled clinical trial. Front Nutr. 2024 Aug 14;11:1442584. doi: 10.3389/fnut.2024.1442584. eCollection 2024. |
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| 1 month to 5 months |
| Crying and sleep tracking (24 hours recall) | frequency | 2 months to 5 months |
| Gastrointestinal tract discomfort | frequency of parents observed and documented GI tract discomfort | 1 month to 5 months |
| Anthropometric parameters on growth | Achieved body length (CM) | 1month to 5 months |
| Anthropometric parameters on growth | Achieved head circumferences (CM) | 1month to 5 months |
| Anthropometric parameters on growth | Achieved body weight (kg) | 1month to 5 months |
| Bone Speed Of Sound | Ultrasound Bone Densitometer (BMD-A3) | at 1 month and 5 months |
| Anthropometric parameters on growth | Rate of gain (%) on achieved head circumferences | 1month to 5 months |
| Anthropometric parameters on growth | Rate of gain (%) on achieved body weight | 1month to 5 months |
| Anthropometric parameters on growth | Rate of gain (%) on achieved body length | 1month to 5 months |
| Jinhua |
| China |