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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480948
Recruitment Status : Terminated (Study design changes were needed due to change of protocol to a multisite trial and updated set up)
First Posted : May 31, 2007
Last Update Posted : June 7, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Behavioral: Infant formula feeding (InFat™) Dietary Supplement: Control Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Stool biochemistry - soaped fatty acids [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Stool biochemistry - total fatty acids and calcium content [ Time Frame: 6 weeks ]
  2. Stool characteristics - 7days diaries [ Time Frame: 3 months ]
  3. General health [ Time Frame: 3 months ]
  4. Anthropometric parameters [ Time Frame: 3-6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480948

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

Responsible Party: Yael Lifshitz PhD, Enzymotec Identifier: NCT00480948     History of Changes
Other Study ID Numbers: InFat™001
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: August 2008

Keywords provided by Enzymotec:
infant formula
fatty acids
palmitic acid

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