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

Not Applicable

Completed

• Conditions: Health Behavior; Personal Satisfaction
• Interventions: Other: InFat™ based infant formula; Other: Standard vegetable oil based infant formula

• Registration Number: NCT01373541
• Lead Sponsor: Enzymotec

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Status Verified: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InFat group	InFat™ based infant formula	Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)
Control group	Standard vegetable oil based infant formula	Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China