NCT00480948

Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Enzymotec · Industry
• Sex: All
• Age: 1 Day – 8 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Infant formula feeding (InFat™)	Infant formula with InFat™ oil (containing \~49% of C16:0 at sn-2 position), 24 wk
DIETARY_SUPPLEMENT	Control	Standard vegetable oil based infant formula

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-08-01
• First posted: 2007-05-31
• Last updated: 2011-06-07

Locations

1 site across 1 country: China