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
  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:


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
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: 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 September 16, 2014