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
The purpose of this study is to assess the growth of infants fed a novel starter formula containing synbiotics and different protein levels, compared to a standard starter infant formula, during the first four months of life.
Breastfeeding represents the "gold standard" for infant health, and efforts are being made to support breast feeding at both the international and local levels. After breast milk, infant formulas are the next best source of nutrition for newborn and growing infants. Science and industry are striving to develop formulas that mimic as close as possible the physiological responses to human milk. There are a multitude of factors that make human milk the physiologically ideal for the infant. Among these, two important factors are the level of protein and the presence of pre-and probiotics in breast milk.
The purpose of this study will be to evaluate growth of healthy infants fed a partially hydrolyzed whey protein formula with a level of protein closer to breast milk, with or without synbiotics, during the first four months of life as compared to the growth of infants fed a partially hydrolyzed whey protein formula with a standard protein level (standard formula). Additionally, the infant's digestive tolerance of the starter formula and frequency of morbidity will be investigated until 6 months of age.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard starter infant formula | Placebo Comparator | standard starter infant formula |
|
| test starter formula | Experimental | test infant formula |
|
| test starter formula with synbiotics | Experimental | starter formula with synbiotics and adapted protein levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| test starter infant formula | Other | infants are fed for 6 months with this starter formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain will be assessed in grams per day, in the period of 14 to 112 days of life (4 months) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance, morbidity, protein status, metabolic markers | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Cabana, MD, MPH | Institute for Health Policy Studies, University of California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Institute for Health Policy Studies/Pediatrics | San Francisco | California | 94118 | United States | ||
Not provided
| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| test starter infant formula with synbiotics | Other | infant are fed for 6 months with this formula |
|
| control standard formula | Other | infant are fed 6 months with this formula |
|
| Florida Institute for Clinical Research |
| Orlando |
| Florida |
| 32822 |
| United States |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | United States |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |