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

NCT ID: NCT00480948

Last Updated: 2011-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

1

Infant formula with InFat™ oil(containing \~49% of C16:0 at sn-2 position).

Group Type: ACTIVE_COMPARATOR

Infant formula feeding (InFat™)

Intervention Type: BEHAVIORAL

Infant formula with InFat™ oil (containing \~49% of C16:0 at sn-2 position), 24 wk

2

Standard vegetable oil based infant formula

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DIETARY_SUPPLEMENT

Standard vegetable oil based infant formula

Interventions

Infant formula feeding (InFat™)

Infant formula with InFat™ oil (containing \~49% of C16:0 at sn-2 position), 24 wk

Intervention Type: BEHAVIORAL

Control

Standard vegetable oil based infant formula

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 8 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Enzymotec

Principal Investigators

Yi Xiang Su, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Yuming Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat Sen University

Guangzhou, , China

Countries

China

Other Identifiers

InFat™001

Identifier Type: -

Identifier Source: org_study_id