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

Personal Satisfaction Clinical Trial

— InFat_002  

Official title:

The Effects of Dietary Palmitic Acid Triacylglyceride Position on Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874068
• Other study ID #: PAL1
• Status: Completed
• Phase: N/A
• First received: March 31, 2009
• Last updated: February 23, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Personal Satisfaction

Intervention

Other:
• InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
• Standard vegetable oil based infant formula
standard vegetable oil based infant formula

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone strength parameters		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks	No
Secondary	stool characteristics		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks	No
Secondary	Antropometric measurements		baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks	Yes