Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Standard infant formula |
|
| Experimental 1 | Experimental | Standard infant formula containing a new fat blend |
|
| Experimental 2 | Experimental | Standard infant formula containing a new fat blend and fiber |
|
| Human Milk (HM) | No Intervention | Non-randomized Human Milk group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant formula | Dietary Supplement | Infant formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool Composition | Stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Consistency determined using a 3-day stool diary | Stool consistency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. Average stool consistency scores are recorded on a validated 5-point scale (1 = Watery, 2 = Runny, 3 = Mushy Soft, 4 = Formed, 5 = Hard). | Days 14 and 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation - LinKou Branch | Linkou District | Tao-Yuan County | Taiwan | |||
| Mackay Memorial Hospital - Hsinchu Branch |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25373935 | Derived | Nowacki J, Lee HC, Lien R, Cheng SW, Li ST, Yao M, Northington R, Jan I, Mutungi G. Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial. Nutr J. 2014 Nov 5;13:105. doi: 10.1186/1475-2891-13-105. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stool frequency determined using a 3-day stool diary | Stool frequency data is collected using a 3-day stool diary completed by parents just prior to the Day 14 and Day 28 clinic visits. The average number of stools per day is determined for each consecutive 3-day period. | Day 14 and 28 |
| GI Tolerance | GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) | Baseline, Day 14 and Day 28 |
| Incidence of adverse events | From ICF signing until 14 days after last study feeding |
| Anthropometric measurements | The anthropometry measurements will be determined by feeding group and by study visit. | Baseline, Day 14 and Day 28 |
| Anthropometric measurements (z-scores) | The z-scores will be determined by feeding group and by study visit. | Baseline, Day 14 and Day 28 |
| Urine osmolality | Measure of hydration status | Baseline and Day 28 |
| Urine pH | Measure of hydration status | Baseline and Day 28 |
| Hsinchu |
| Taiwan |
| Chang Gung Medical Foundation, Taipei Branch | Taipei | Taiwan |
| Mackay Memorial Hospital | Taipei | Taiwan |
| D005526 |
| Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |