Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.

Detailed Description
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In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption. Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions. Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula. InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position. The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.

Official Title
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Effects of InFat™ Product (High Sn-2 Palmitic Acid) on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants: a Triple-blind, Randomized, Placebo-controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Infant formula feeding (InFat™)
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term infants: gestation 37-40 weeks Birth weight 2500-4000 g Apparent good health The infant is a product of normal pregnancy and delivery. Exclusion Criteria: Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis) Born with a 5- or 10-minute Apgar score <7 Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula) Breast-feeding for a week or over. 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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Minimum Age: 1 Day
Maximum Age: 8 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: 1<br>Infant formula with InFat™ oil(containing  49% of C16:0 at sn-2 position). | Behavioral: Infant formula feeding (InFat™)<br>* Infant formula with InFat™ oil (containing  49% of C16:0 at sn-2 position), 24 wk<br>|
| Placebo Comparator: 2<br>Standard vegetable oil based infant formula | Dietary Supplement: Control<br>* Standard vegetable oil based infant formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool biochemistry - soaped fatty acids |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool biochemistry - total fatty acids and calcium content |  | 6 weeks | 
| Stool characteristics - 7days diaries |  | 3 months | 
| General health |  | 3 months | 
| Anthropometric parameters |  | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, infant formula, fatty acids, palmitic acid, stool, calcium