The Effect of Feeding Infant Formula With Enriched Protein Fractions

Study Overview
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Brief Summary
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This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Detailed Description
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To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.

Official Title
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The Effect of Feeding Infant Formula With Enriched Protein Fractions

Conditions
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Cognitive Ability, General

Intervention / Treatment
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* Dietary Supplement: Enriched Protein Fractions
* Dietary Supplement: Protein Fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-14 days of age Exclusively formula-fed Singleton birth Gestational age of 37-42 weeks Birth weight of 2500g to 4000g Signed Informed Consent Form Exclusion Criteria: History of underlying metabolic or chronic disease Congenital malformation Condition which is likely to interfere with food ingestion, normal growth, development and evaluation Evidence of feeding difficulties or intolerance Immunocompromised Head/brain disease/injury

Ages Eligible for Study
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Minimum Age: 10 Days
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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enriched Protein Fractions<br>This group is given Infant formula with enriched protein fractions. | Dietary Supplement: Enriched Protein Fractions<br>* Enriched protein fractions<br>|
| Active Comparator: Protein Fractions<br>This group is given Infant formula with protein fractions. | Dietary Supplement: Protein Fractions<br>* Protein fractions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant cognitive development | Cognitive Scale of Bayley-III is used as the assessment tool. | At 12 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant cognitive development | Cognitive Scale of Bayley-III is used as the assessment tool. | At 18 months of age | 
| Infant language and motor skills | Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool. | At 4, 6, 9, 12 and 18 months of age | 
| Infant acquisition of social and emotional milestones and adaptive development | Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool. | At 4, 6, 9, 12 and 18 months of age | 
| Infant temperament | Carey Scale is used as assessment tool. | At 12 and 18 months of age | 
| Infant attention capabilities | Single Object Attention and Free Play Tasks is used as assessment tool. | At 12 and 18 months of age | 
| Physical development | Body weight, length and head circumference are measured. | At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age | 
| Stool characteristics | According to the recall of parents during the last 24 hours. | At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age | 
| Formula intake | According to the recall of parents during the last 24 hours. | At 30, 42, 60, 90, 120, 180, 275 and 365 days of age | 
| Fecal microbiome and metabolome profile | Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age. | Average of 14 days of age and 120 days of age | 
| Medically-confirmed Adverse Events |  | Up to 19 months of age |