Healthy infants
Conditions
Interventions
Intervention group: cow’s milk-based nutritionally complete infant formula. Control group: commercially available cow’s milk-based nutritionally complete infant formula.
Foods and nutrients
Sponsors
Danone Nutricia Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, singleton, term born infants with gestational age of 37 – 42 weeks. 2. Infants aged = 14 days at enrollment. 3. Birth weight within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards. 4. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study. 5. Written informed consent (IC) from parent(s) and/or legal guardian(s) aged =18 years at screening.
Exclusion criteria
Exclusion criteria: 1. Infants known or suspected to have cow's milk allergy, fish protein allergy, soy allergy and/or lactose intolerance. 2. Infants with current or previous illnesses/conditions which could interfere with the study outcomes, as assessed by the investigator. 3. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is weight gain (grams per day) [Time frame: enrollment to 16 weeks of intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight [Time frame: enrollment to 16 weeks of intervention] Weight gain in grams/ day 2. Length [Time frame: enrollment to 16 weeks of intervention] Length gain in cm/ day 3. Head circumference [Time frame: enrollment to 16 weeks of intervention] Head circumference gain in cm/ day 4. Study product intake [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 5. Gastrointestinal tolerance [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 6. Adverse events [Time frame: enrollment to 16 weeks of intervention] Standard adverse event reporting Other outcomes 1. Infant stool characteristics [Time frame: enrollment to 16 weeks of intervention] Parent completed diary 2. Infant stool microbiota composition and functionality [Time frame: enrollment to 16 weeks of intervention] Stool sampling 3. Study product appreciation questionnaire [Time frame: enrollment to 16 weeks of intervention] Parent completed questionnaire | — |
Countries
United States
Outcome results
None listed