The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)

Enzymotec

Status

Completed

Conditions

Health Behavior

Disorder of Growth and Development

Treatments

Other: InFat™ based infant formula

Other: Standard vegetable oil based infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01116115

InFat_005

Details and patient eligibility

About

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.

Full description

InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.

Enrollment

30 patients

Sex

All

Ages

Under 7 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Parental/ legal guardian written inform consent
The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
Birth weight appropriate for gestational age (AGA).
The infant is apparently healthy at birth and entry to study.
Apgar after 5 minutes >7
Enrolled within their first 7 days of life
The infant is a product of normal pregnancy and delivery, including C-section.
Parental ability to attend visits and interviews and willing to fill questionnaires.

Exclusion criteria

Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
The infant or mother was treated with antibiotics around birth.