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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
171
high sn-2 palmitic acid oil based infant formula
standard vegetable oil based infant formula
Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
Shanghai, China
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
Time frame: 6 postnatal weeks
Anthropometric parameters: body length, body weight, and head circumferences at each visit
Time frame: Baseline, 6, 12 and 24 postnatal weeks
Dietary, stool consistency and well being recorded by 3 day questionnaires
Time frame: 6, 12 and 24 postnatal weeks
Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
Time frame: Baseline, 6,12 and 24 postnatal weeks
Bone speed of sound measured by ultrasonic device at each visit
Time frame: Baseline, 6,12 and 24 postnatal weeks
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