The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants (InFat_002)

Enzymotec

Status: Completed

Conditions: Personal Satisfaction

Treatments: Other: Standard vegetable oil based infant formula; Other: InFat™ based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00874068

PAL1

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 bone strength parameters.

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 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.

Enrollment: 94 patients

Sex: All

Ages: Under 1 month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 3 patient groups

Standard vegetable oil formula

Active Comparator group

Treatment:

Other: Standard vegetable oil based infant formula

InFat

Active Comparator group

Treatment:

Other: InFat™ based infant formula

Breast-fed

No Intervention group