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

Phase 4

Terminated

• Conditions: Healthy
• Interventions: Behavioral: Infant formula feeding (InFat™); Dietary Supplement: Control

• Registration Number: NCT00480948
• Lead Sponsor: Enzymotec

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 (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 Timeline

• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Status Verified: 2008-08
• Study Start: 2008-09
• Primary Completion: 2009-04
• Study Completion: 2009-08
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Infant formula feeding (InFat™)	Infant formula with InFat™ oil(containing \~49% of C16:0 at sn-2 position).
2	Control	Standard vegetable oil based infant formula

Primary Outcome Measures

Name	Time	Method
Stool biochemistry - soaped fatty acids	6 weeks

Secondary Outcome Measures

Name	Time	Method
Stool biochemistry - total fatty acids and calcium content	6 weeks
Stool characteristics - 7days diaries	3 months
General health	3 months
Anthropometric parameters	3-6 months

Trial Locations

Locations (1)

Sun Yat Sen University; 🇨🇳 Guangzhou, China