Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480948
Status:
TERMINATED
Last Update Posted:
2011-06-07
First Post:
2007-05-30
Brief Title:
Effects of InFat Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
Sponsor:
Enzymotec
Organization:
Enzymotec
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study design changes were needed due to change of protocol to a multisite trial and updated set up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 C160 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
Palmitic acid C160 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None