Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants
- Conditions
- Healthy
- Registration Number
- NCT00480948
- Lead Sponsor
- Enzymotec
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
- Term infants: gestation 37-40 weeks
- Birth weight 2500-4000 g
- Apparent good health
- The infant is a product of normal pregnancy and delivery.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stool biochemistry - soaped fatty acids 6 weeks
- Secondary Outcome Measures
Name Time Method Stool biochemistry - total fatty acids and calcium content 6 weeks Stool characteristics - 7days diaries 3 months General health 3 months Anthropometric parameters 3-6 months
Trial Locations
- Locations (1)
Sun Yat Sen University
🇨🇳Guangzhou, China
Sun Yat Sen University🇨🇳Guangzhou, China