The Effects of Dietary Palmitic Acid Triacylglyceride Position on Bone Strength Parameters in Infants (InFat_002)
February 23, 2011 updated by: Enzymotec
The Effects of Dietary Palmitic Acid Triacylglyceride Position on Anthropometric Measures, Bone Strength Parameters, Stool Characteristics and Stool Biochemistry in Preterm and Term Infants
The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on bone strength parameters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kfar Saba, Israel
- Meir Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Gestational age above 32 weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
- Birth weight appropriate for gestational age (AGA) using current CDC growth charts, and above 1750gr.
- 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).
- The infant is apparently healthy.
- Parental/ legal guardian written inform consent
- Apgar after 5 minutes >7
- Enrolled within their first 14 days of life for term infants and first month of life for preterm infants
- At enrollment: clinical stability and acceptable weight gain
Exclusion Criteria:
- The infant suffer from a congenital or chromosomal disorder (Cystic fibrosis, Tracheomalacia, Tracheoesophageal fistula, major congenital heart disease, down-syndrome)
The infant suffer from neonatal morbidities:
- Bronchopulmonary dysplasia (BPD)
- Intraventricular Hemorrhage3-4 (IVH)
- Necrotizing Enterocolitis (NEC)
- Laboratory or clinical sings of Osteopenia
- The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
- The mother suffers from any disease or disability that may interfere with her ability to take care of her infant
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Standard vegetable oil formula
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standard vegetable oil based infant formula
Other Names:
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ACTIVE_COMPARATOR: InFat
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high sn-2 palmitic acid oil based infant formula
Other Names:
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NO_INTERVENTION: Breast-fed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
bone strength parameters
Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
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baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
stool characteristics
Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
|
baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
|
|
Antropometric measurements
Time Frame: baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
|
baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
March 31, 2009
First Submitted That Met QC Criteria
April 1, 2009
First Posted (ESTIMATE)
April 2, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 24, 2011
Last Update Submitted That Met QC Criteria
February 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAL1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.