Clinical trial NCT00480948: Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Healthy
Keywords: infant
infant formula
fatty acids
palmitic acid
stool
calcium
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Stool biochemistry - soaped fatty acids
timeFrame: 6 weeks
Secondary outcomes:
measure: Stool biochemistry - total fatty acids and calcium content
timeFrame: 6 weeks
measure: Stool characteristics - 7days diaries
timeFrame: 3 months
measure: General health
timeFrame: 3 months
measure: Anthropometric parameters
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat Sen University
Study officials:
affiliation: Sun Yat-sen University
name: Yi Xiang Su, MD Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Yuming Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: