Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China

February 11, 2014 updated by: Enzymotec

Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial

The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.

Study Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

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
      • Shanghai, China
        • Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine

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 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parental/legal guardian written informed consent;
  • The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
  • Term infant of Chinese origin born at 37-42 gestation weeks
  • Birth weight appropriate for gestational age (AGA), 2500-4000grams
  • The infant is apparently healthy at birth and entry of study.

Exclusion Criteria:

  • Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
  • The infant is not a singleton newborn

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: InFat group
Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)
Other: InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Other Names:
  • high sn-2 palmitic acid
  • structured triglyceride
ACTIVE_COMPARATOR: Control group
Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)
Other: Standard vegetable oil based infant formula
standard vegetable oil based infant formula
Other Names:
  • standard vegetable oil
NO_INTERVENTION: Referance group
Human milk breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
Time Frame: 6 postnatal weeks
6 postnatal weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Anthropometric parameters: body length, body weight, and head circumferences at each visit
Time Frame: Baseline, 6, 12 and 24 postnatal weeks
Baseline, 6, 12 and 24 postnatal weeks
Dietary, stool consistency and well being recorded by 3 day questionnaires
Time Frame: 6, 12 and 24 postnatal weeks
6, 12 and 24 postnatal weeks
Number of participants with adverse events and concomitant medications as a measure of safety and tolerability
Time Frame: Baseline, 6,12 and 24 postnatal weeks
Baseline, 6,12 and 24 postnatal weeks
Bone speed of sound measured by ultrasonic device at each visit
Time Frame: Baseline, 6,12 and 24 postnatal weeks
Baseline, 6,12 and 24 postnatal weeks

Collaborators and Investigators

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

Sponsor

Enzymotec

Collaborators

Biostime, Inc. (Guangzhou)

Investigators

  • Principal Investigator: Xu Chundix, Prof., Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (ESTIMATE)

June 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 11, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InFat_003

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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