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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Biostime, Inc. (Guangzhou)

Information provided by (Responsible Party):

Enzymotec

ClinicalTrials.gov Identifier:

NCT01373541

First received: June 13, 2011

Last updated: December 4, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2011

Last Updated Date

December 4, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01373541 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Anthropometric parameters: body length, body weight, and head circumferences at each visit [ Time Frame: Baseline, 6, 12 and 24 postnatal weeks ] [ Designated as safety issue: Yes ]
Dietary, stool consistency and well being recorded by 3 day questionnaires [ Time Frame: 6, 12 and 24 postnatal weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Bone speed of sound measured by ultrasonic device at each visit [ Time Frame: Baseline, 6,12 and 24 postnatal weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Health Behavior
Personal Satisfaction

Intervention ^ICMJE

Other: InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Other Names:
- high sn-2 palmitic acid
- structured triglyceride
Other: Standard vegetable oil based infant formula
standard vegetable oil based infant formula

Other Name: standard vegetable oil

Study Arm (s)

Active Comparator: InFat group
Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)

Intervention: Other: InFat™ based infant formula
Active Comparator: Control group
Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)

Intervention: Other: Standard vegetable oil based infant formula
No Intervention: Referance group
Human milk breastfeeding

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

171

Estimated Completion Date

May 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 14 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01373541

Other Study ID Numbers ^ICMJE

InFat_003

Has Data Monitoring Committee

Responsible Party

Enzymotec

Study Sponsor ^ICMJE

Enzymotec

Collaborators ^ICMJE

Biostime, Inc. (Guangzhou)

Investigators ^ICMJE

Principal Investigator:

Xu Chundix, Prof.

Ruijin Hospital Shanghai - Jiao Tong University, School of Medicine

Information Provided By

Enzymotec

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top