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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Personal Satisfaction

Intervention / Treatment
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* Other: InFat™ based infant formula
* Other: Standard vegetable oil based infant formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard vegetable oil formula<br> | Other: Standard vegetable oil based infant formula<br>* standard vegetable oil based infant formula<br>* Other names: standard vegetable oil;|
| Active Comparator: InFat<br> | Other: InFat™ based infant formula<br>* high sn-2 palmitic acid oil based infant formula<br>* Other names: structured triglyceride;|
| No Intervention: Breast-fed<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone strength parameters |  | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stool characteristics |  | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks | 
| Antropometric measurements |  | baseline, 40 corrected gestation weeks, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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term infants, preterm infants, bone strength, Speed of sound (SOS), Ultrasound