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

This study has been completed.
Sponsor:
Collaborator:
Biostime, Inc. (Guangzhou)
Information provided by (Responsible Party):
Enzymotec
ClinicalTrials.gov Identifier:
NCT01373541
First received: June 13, 2011
Last updated: February 11, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention
Health Behavior
Personal Satisfaction
Other: InFat™ based infant formula
Other: Standard vegetable oil based infant formula

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

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 171
Study Start Date: May 2011
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: standard vegetable oil
No Intervention: Referance group
Human milk breastfeeding

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.

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373541

Locations
China
Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Enzymotec
Biostime, Inc. (Guangzhou)
Investigators
Principal Investigator: Xu Chundix, Prof. Ruijin Hospital Shanghai - Jiao Tong University, School of Medicine
  More Information

No publications provided

Responsible Party: Enzymotec
ClinicalTrials.gov Identifier: NCT01373541     History of Changes
Other Study ID Numbers: InFat_003
Study First Received: June 13, 2011
Last Updated: February 11, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014