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Completed

NCT Number: NCT01373541

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

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.

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Key information

Conditions

Health Behavior Behavior Personal Satisfaction

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InFat™ based infant formula

Other

high sn-2 palmitic acid oil based infant formula

Other names: high sn-2 palmitic acid, structured triglyceride

Standard vegetable oil based infant formula

Other

standard vegetable oil based infant formula

Other names: standard vegetable oil

Primary outcomes

  1. Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis

    Time frame: 6 postnatal weeks

Secondary outcomes

  1. Anthropometric parameters: body length, body weight, and head circumferences at each visit

    Time frame: Baseline, 6, 12 and 24 postnatal weeks

  2. Dietary, stool consistency and well being recorded by 3 day questionnaires

    Time frame: 6, 12 and 24 postnatal weeks

  3. Number of participants with adverse events and concomitant medications as a measure of safety and tolerability

    Time frame: Baseline, 6,12 and 24 postnatal weeks

  4. Bone speed of sound measured by ultrasonic device at each visit

    Time frame: Baseline, 6,12 and 24 postnatal weeks

Sponsors and collaborators

Lead sponsor

Enzymotec

Industry

Collaborators

  • Biostime, Inc. (Guangzhou)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 15, 2011
Registry last updated
Feb 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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