Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants

Not Applicable

• Conditions: Healthy
• Interventions: Other: Placebo; Other: β-Palmitate Content; Other: β-Palmitate Content Naturely in Human Milk

• Registration Number: NCT02587702
• Lead Sponsor: Beingmate Baby & Child Food Co Ltd .

Brief Summary

The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy full term infants

Exclusion Criteria

• experienced congenital or chromosomal disorders
• neonatal morbidities, or metabolic illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Infant Formula Group	Placebo	Excluding β-Palmitate Content
Improved Infant Formula Group	β-Palmitate Content	Containing β-Palmitate Content
Human Milk Group	β-Palmitate Content Naturely in Human Milk	Containing β-Palmitate Content Naturely in Human Milk

Primary Outcome Measures

Name	Time	Method
Content of fatty acids	3 years
Content of calcium and magnesium	3 years

Secondary Outcome Measures

Name	Time	Method
Stool characteristics assessed via stool frequency	3 years
Anthropometric measurements	3 years	Index of anthropometric measurements contains weight,height and head circumference.
Stool characteristics assessed via stool consistency	3 years

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, China