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

Enzymotec

Status: Completed

Conditions: Personal Satisfaction; Health Behavior

Treatments: Other: InFat™ based infant formula; Other: Standard vegetable oil based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01373541

InFat_003

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 171 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

171 participants in 3 patient groups

InFat group

Active Comparator group

Description:

Infant formula with structured triglycerides (high palmitic acid content at the sn-2 position)

Treatment:

Other: InFat™ based infant formula

Control group

Active Comparator group

Description:

Infant formula with standard vegetable blend (low palmitic acid content at the sn-2 position)

Treatment:

Other: Standard vegetable oil based infant formula

Referance group

No Intervention group

Description:

Human milk breastfeeding