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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00480948
• Other study ID #: InFat™001
• Status: Terminated
• Phase: Phase 4
• First received: May 30, 2007
• Last updated: June 6, 2011
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2008
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: August 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Infant formula feeding (InFat™)
Infant formula with InFat™ oil (containing ~49% of C16:0 at sn-2 position), 24 wk

Dietary Supplement:
• Control
Standard vegetable oil based infant formula

Locations

Country	Name	City	State
China	Sun Yat Sen University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool biochemistry - soaped fatty acids		6 weeks	No
Secondary	Stool biochemistry - total fatty acids and calcium content		6 weeks	No
Secondary	Stool characteristics - 7days diaries		3 months	No
Secondary	General health		3 months	No
Secondary	Anthropometric parameters		3-6 months	No