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The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
The purpose of this study is to evaluate the effects of term infant formula containing high 2-palmitic vegetable oil on stool composition and characteristics and to investigate the effect of both high 2-palmitic vegetable oil and oligofructose in infant formula on stool softness and bacteria. Because some studies demonstrate the benefit of high concentrations of a non-digestible carbohydrate in the formula, we will study 2 concentrations of added oligofructose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (EF) 1 | Experimental | For 8 weeks, infants will consume ad libitum per day S-26 Gold EF1 |
|
| Standard Formula | Active Comparator | For 8 weeks, infants will consume ad libitum per day. S-26 Gold |
|
| Experimental 2 (EF2) S-26 Gold | Experimental | For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF2 |
|
| Human milk (HM) | Other | For 8 weeks, infants will consume ad libitum per day. Human Milk |
|
| Experimental formula (EF) 3 | Experimental | For 8 weeks, infants will consume ad libitum per day. S-26 Gold EF3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-26 Gold | Other | (13.4 g/L protein) with 100% Fat Blend A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Composition in Healthy Term Infants Fed Human Milk or Infant Formulas | stool composition: stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas | Determinations of fecal flora as well as fecal pH, sIgA concentrations and SCFA concentrations in a subset of subjects. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation | evaluation of adverse events | 10 weeks |
| Growth evaluation | Anthropometric measurements | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Rosario Zeta Capeding, MD | JRF Health Center Complex, Muntinlupa City, Philippines | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Hospital and Medical Center | Metro Manila | Alabang | 1780 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24840511 | Derived | Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443. |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| S-26 Gold EF1 |
| Other |
(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend |
|
| S-26 Gold EF2 | Other | (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose |
|
| S-26 Gold EF3 | Other | (13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose |
|
| Human Milk | Other | Human Milk |
|
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |