Healthy Clinical Trial
Official title:
Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
In human breast milk, and in most infant formulas more than 98% of this milk fat is in the
form of triglycerides, which contain saturated and unsaturated fatty acids esterified to
glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on
the glycerol backbone and this specific configuration is known to have a major contribution
to the efficacy of this nutrient absorption.
Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the
sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard
infant formulas is esterified to the sn-1 and sn-3 positions.
Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and
better calcium absorption as compared to standard infant formula.
InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2
position.
The primary objective of this trial is to demonstrate that feeding Chinese term infants,
with formula having proportion of palmitate in the sn-2 position comparable to human milk,
reduces calcium-soaps formation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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