Clinical trial NCT01373541: Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
Official title: Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Personal Satisfaction
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
Collaborators: name: Biostime, Inc. (Guangzhou)
First posted: 2011-06-15
Enrollment: 171
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
timeFrame: 6 postnatal weeks
Secondary outcomes:
measure: Anthropometric parameters: body length, body weight, and head circumferences at each visit
timeFrame: Baseline, 6, 12 and 24 postnatal weeks
measure: Dietary, stool consistency and well being recorded by 3 day questionnaires
timeFrame: 6, 12 and 24 postnatal weeks
measure: Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
timeFrame: Baseline, 6,12 and 24 postnatal weeks
measure: Bone speed of sound measured by ultrasonic device at each visit
timeFrame: Baseline, 6,12 and 24 postnatal weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Xu Chundix, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.