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

Enzymotec

Status and phase

Terminated

Phase 4

Conditions

Healthy

Treatments

Behavioral: Infant formula feeding (InFat™)

Dietary Supplement: Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT00480948

InFat™001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

1 to 8 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Term infants: gestation 37-40 weeks
Birth weight 2500-4000 g
Apparent good health
The infant is a product of normal pregnancy and delivery.

Exclusion criteria

Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
Born with a 5- or 10-minute Apgar score <7
Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
Breast-feeding for a week or over.
Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.