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Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants

This study has been terminated.
(Study design changes were needed due to change of protocol to a multisite trial and updated set up)
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT00480948
First received: May 30, 2007
Last updated: June 6, 2011
Last verified: August 2008
History of Changes
  Purpose

The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.


Condition Intervention Phase
Healthy
 Behavioral: Infant formula feeding (InFat™)
Dietary Supplement: Control
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • Stool biochemistry - soaped fatty acids [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stool biochemistry - total fatty acids and calcium content [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Stool characteristics - 7days diaries [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • General health [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Anthropometric parameters [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Infant formula with InFat™ oil(containing ~49% of C16:0 at sn-2 position).
 Behavioral: Infant formula feeding (InFat™)
Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk
Placebo Comparator: 2
Standard vegetable oil based infant formula
 Dietary Supplement: Control
Standard vegetable oil based infant formula

Detailed Description:

In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption.

Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions.

Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula.

InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position.

The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infants: gestation 37-40 weeks
  • Birth weight 2500-4000 g
  • Apparent good health
  • The infant is a product of normal pregnancy and delivery.

Exclusion Criteria:

  • Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
  • Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
  • Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
  • Born with a 5- or 10-minute Apgar score <7
  • Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
  • Breast-feeding for a week or over.
  • Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480948

Locations
China
Sun Yat Sen University
Guangzhou, China, 510080
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Yi Xiang Su, MD Professor Sun Yat-sen University
Principal Investigator: Yuming Chen, PhD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Yael Lifshitz PhD, Enzymotec
ClinicalTrials.gov Identifier: NCT00480948     History of Changes
Other Study ID Numbers: InFat™001
Study First Received: May 30, 2007
Last Updated: June 6, 2011
Health Authority: China: Ethics Committee

Keywords provided by Enzymotec:
infant
infant formula
fatty acids
 palmitic acid
stool
calcium

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

ClinicalTrials.gov processed this record on May 19, 2013