Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
NCT ID: NCT01373541
Last Updated: 2014-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
171 participants
INTERVENTIONAL
2011-05-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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InFat group
Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)
InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Control group
Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)
Standard vegetable oil based infant formula
standard vegetable oil based infant formula
Referance group
Human milk breastfeeding
No interventions assigned to this group
Interventions
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InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Standard vegetable oil based infant formula
standard vegetable oil based infant formula
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* The infant is not a singleton newborn
1 Day
14 Days
ALL
Yes
Sponsors
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Biostime, Inc. (Guangzhou)
INDUSTRY
Enzymotec
INDUSTRY
Responsible Party
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Principal Investigators
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Xu Chundix, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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References
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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.
Other Identifiers
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InFat_003
Identifier Type: -
Identifier Source: org_study_id
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