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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
80
Infant formula with InFat™ oil (containing \~49% of C16:0 at sn-2 position), 24 wk
Standard vegetable oil based infant formula
Sun Yat Sen University
Guangzhou, China
Stool biochemistry - soaped fatty acids
Time frame: 6 weeks
Stool biochemistry - total fatty acids and calcium content
Time frame: 6 weeks
Stool characteristics - 7days diaries
Time frame: 3 months
General health
Time frame: 3 months
Anthropometric parameters
Time frame: 3-6 months
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