Health Behavior, Personal Satisfaction
Conditions
Brief summary
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
Detailed description
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) 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.
Interventions
high sn-2 palmitic acid oil based infant formula
standard vegetable oil based infant formula
Sponsors
Biostime, Inc. (Guangzhou)
Enzymotec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Parental/legal guardian written informed consent; * The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants). * Term infant of Chinese origin born at 37-42 gestation weeks * Birth weight appropriate for gestational age (AGA), 2500-4000grams * The infant is apparently healthy at birth and entry of study.
Exclusion criteria
* Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development * The infant is not a singleton newborn
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
China
Outcome results
None listed