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| Name | Class |
|---|---|
| Biostime, Inc. (Guangzhou) | INDUSTRY |
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The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFatâ„¢) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFatâ„¢) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InFat group | Active Comparator | Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position) |
|
| Control group | Active Comparator | Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position) |
|
| Referance group | No Intervention | Human milk breastfeeding |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InFatâ„¢ based infant formula | Other | high sn-2 palmitic acid oil based infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis | 6 postnatal weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric parameters: body length, body weight, and head circumferences at each visit | Baseline, 6, 12 and 24 postnatal weeks | |
| Dietary, stool consistency and well being recorded by 3 day questionnaires | 6, 12 and 24 postnatal weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xu Chundix, Prof. | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26334255 | Derived | Bar-Yoseph F, Lifshitz Y, Cohen T, Malard P, Xu C. SN2-Palmitate Reduces Fatty Acid Excretion in Chinese Formula-fed Infants. J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):341-7. doi: 10.1097/MPG.0000000000000971. |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Standard vegetable oil based infant formula | Other | standard vegetable oil based infant formula |
|
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| Number of participants with adverse events and concomitant medications as a measure of safety and tolerability | Baseline, 6,12 and 24 postnatal weeks |
| Bone speed of sound measured by ultrasonic device at each visit | Baseline, 6,12 and 24 postnatal weeks |