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

This study has been completed.
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT00874068
First received: March 31, 2009
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention
Personal Satisfaction
Other: InFat™ based infant formula
Other: Standard vegetable oil based infant formula

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

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • bone strength parameters [ Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • stool characteristics [ Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Antropometric measurements [ Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard vegetable oil formula Other: Standard vegetable oil based infant formula
standard vegetable oil based infant formula
Other Name: standard vegetable oil
Active Comparator: InFat Other: InFat™ based infant formula
high sn-2 palmitic acid oil based infant formula
Other Names:
  • high sn-2 palmitic acid
  • structured triglyceride
No Intervention: Breast-fed

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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874068

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Dan Nemet, MD Meir Medical Center
  More Information

No publications provided by Enzymotec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fabiana Bar-Yoseph, Enzymotec
ClinicalTrials.gov Identifier: NCT00874068     History of Changes
Other Study ID Numbers: PAL1
Study First Received: March 31, 2009
Last Updated: February 23, 2011
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Enzymotec:
term infants
preterm infants
bone strength
Speed of sound (SOS)
Ultrasound

Additional relevant MeSH terms:
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014