The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)

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 intestinal parameters in term formula fed infants.

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 result of a unique fatty acid composition on the glycerol backbone, which ensures 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 intestinal parameters, anthropometric parameters and stool characteristics in formula fed term infants.

Official Title
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The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants

Conditions
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Health Behavior, Disorder of Growth and Development

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: Parental/ legal guardian written inform consent 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). Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination. Birth weight appropriate for gestational age (AGA). The infant is apparently healthy at birth and entry to study. Apgar after 5 minutes >7 Enrolled within their first 7 days of life The infant is a product of normal pregnancy and delivery, including C-section. Parental ability to attend visits and interviews and willing to fill questionnaires. Exclusion Criteria: Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results. The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth. The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula). The infant or mother was treated with antibiotics around birth.

Ages Eligible for Study
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Maximum Age: 7 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard vegetable oil based 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™ based infant formula<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 |
| --- | --- | --- |
| Intestinal flora composition | infant feces microbial analysis | Baseline, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Body length, weight, and head circumferences | Baseline, 5 weeks | 
| General Health and Well being | Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report | Baseline, 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Term Infants, Intestine flora, Stool characteristics