The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants

Not Applicable

Completed

• Conditions: Personal Satisfaction
• Interventions: Other: Standard vegetable oil based infant formula; Other: InFat™ based infant formula

• Registration Number: NCT00874068
• 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 bone strength parameters.

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 results of a unique fatty acid composition on the glycerol backbone, which ensure 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 bone strength parameters, anthropometric parameters, wellbeing and stool characteristics in term and preterm infants.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
2. Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
3. 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).
4. The infant is apparently healthy.
5. Parental/ legal guardian written inform consent
6. Apgar after 5 minutes >7
7. Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
8. At enrollment: clinical stability and acceptable weight gain

Exclusion Criteria

1. The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)

2. The infant suffer from neonatal morbidities:

   • Bronchopulmonary dysplasia (BPD)
   • Intraventricular Hemorrhage3-4 (IVH)
   • Necrotizing Enterocolitis (NEC)

3. Laboratory or clinical sings of Osteopenia

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 mother suffers from any disease or disability that may interfere with her ability to take care of her infant

6. 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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
bone strength parameters	baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Antropometric measurements	baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
stool characteristics	baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel