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

Not Applicable

Completed

• Conditions: Health Behavior; Disorder of Growth and Development
• Interventions: Other: Standard vegetable oil based infant formula; Other: InFat™ based infant formula

• Registration Number: NCT01116115
• Lead Sponsor: Enzymotec

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Parental/ legal guardian written inform consent
2. 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).
3. Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
4. Birth weight appropriate for gestational age (AGA).
5. The infant is apparently healthy at birth and entry to study.
6. Apgar after 5 minutes >7
7. Enrolled within their first 7 days of life
8. The infant is a product of normal pregnancy and delivery, including C-section.
9. Parental ability to attend visits and interviews and willing to fill questionnaires.

Exclusion Criteria

1. 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.
2. 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.
3. The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
5. The infant or mother was treated with antibiotics around birth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard vegetable oil based formula	Standard vegetable oil based infant formula	-
InFat™ based infant formula	InFat™ based infant formula	-

Primary Outcome Measures

Name	Time	Method
Intestinal flora composition	Baseline, 5 weeks	infant feces microbial analysis

Secondary Outcome Measures

Name	Time	Method
Anthropometric measurements	Baseline, 5 weeks	Body length, weight, and head circumferences
General Health and Well being	Baseline, 5 weeks	Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report

Trial Locations

Locations (1)

Bnai Zion Medical center; 🇮🇱 Haifa, Israel