Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.

Detailed Description
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The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed term infants.

Official Title
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Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial

Conditions
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Health Behavior, 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: Parental/legal guardian written informed consent; The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants). Term infant of Chinese origin born at 37-42 gestation weeks Birth weight appropriate for gestational age (AGA), 2500-4000grams The infant is apparently healthy at birth and entry of study. Exclusion Criteria: Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development The infant is not a singleton newborn

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: InFat group<br>Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position) | Other: InFat™ based infant formula<br>* high sn-2 palmitic acid oil based infant formula<br>* Other names: structured triglyceride;|
| Active Comparator: Control group<br>Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position) | Other: Standard vegetable oil based infant formula<br>* standard vegetable oil based infant formula<br>* Other names: standard vegetable oil;|
| No Intervention: Referance group<br>Human milk breastfeeding | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis |  | 6 postnatal weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric parameters: body length, body weight, and head circumferences at each visit |  | Baseline, 6, 12 and 24 postnatal weeks | 
| Dietary, stool consistency and well being recorded by 3 day questionnaires |  | 6, 12 and 24 postnatal weeks | 
| Number of participants with adverse events and concomitant medications as a measure of safety and tolerability |  | Baseline, 6,12 and 24 postnatal weeks | 
| Bone speed of sound measured by ultrasonic device at each visit |  | Baseline, 6,12 and 24 postnatal weeks |