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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373541
• Other study ID #: InFat_003
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: February 11, 2014
• Start date: May 2011
• Est. completion date: May 2013

Study information

• Verified date: January 2012
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

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

Related Conditions & MeSH terms

• Health Behavior
• Personal Satisfaction

Intervention

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

Locations

Country	Name	City	State
China	Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Enzymotec	Biostime, Inc. (Guangzhou)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anthropometric parameters: body length, body weight, and head circumferences at each visit		Baseline, 6, 12 and 24 postnatal weeks	Yes
Secondary	Dietary, stool consistency and well being recorded by 3 day questionnaires		6, 12 and 24 postnatal weeks	No
Secondary	Number of participants with adverse events and concomitant medications as a measure of safety and tolerability		Baseline, 6,12 and 24 postnatal weeks	Yes
Secondary	Bone speed of sound measured by ultrasonic device at each visit		Baseline, 6,12 and 24 postnatal weeks	No