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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
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 171
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated 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
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: December 4, 2012
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 May 23, 2013