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

June 6, 2011 updated by: Enzymotec

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 510080
        • Sun Yat Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Infant formula with InFat™ oil(containing ~49% of C16:0 at sn-2 position).
Behavioral: Infant formula feeding (InFat™)
Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk
Placebo Comparator: 2
Standard vegetable oil based infant formula
Dietary supplement: Control
Standard vegetable oil based infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool biochemistry - soaped fatty acids
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool biochemistry - total fatty acids and calcium content
Time Frame: 6 weeks
6 weeks
Stool characteristics - 7days diaries
Time Frame: 3 months
3 months
General health
Time Frame: 3 months
3 months
Anthropometric parameters
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzymotec

Investigators

  • Principal Investigator: Yi Xiang Su, MD Professor, Sun Yat-sen University
  • Principal Investigator: Yuming Chen, PhD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (Estimate)

May 31, 2007

Study Record Updates

Last Update Posted (Estimate)

June 7, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • InFat™001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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