Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China

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.

• InFat™ based infant formula (Other), also known as high sn-2 palmitic acid, structured triglyceride: high sn-2 palmitic acid oil based infant formula
• Standard vegetable oil based infant formula (Other), also known as standard vegetable oil: standard vegetable oil based infant formula

Primary outcomes

• 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 outcomes

• 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]

Sex: All, ages: 1 Day to 14 Days, accepts healthy volunteers

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

• Results publication: Bar-Yoseph F, Lifshitz Y, Cohen T, Malard P, Xu C. SN2-Palmitate Reduces Fatty Acid Excretion in Chinese Formula-fed Infants. J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):341-7. doi: 10.1097/MPG.0000000000000971. PMID 26334255

• Xu Chundix, Prof., Principal investigator, Ruijin Hospital