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

NCT01373541 | Completed

• 1 other identifier: InFat_003
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Personal Satisfaction

Outcome Measures

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

  6 postnatal weeks

Secondary Outcomes (4)

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

  Baseline, 6, 12 and 24 postnatal weeks

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

  6, 12 and 24 postnatal weeks

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

  Baseline, 6,12 and 24 postnatal weeks

• Bone speed of sound measured by ultrasonic device at each visit

  Baseline, 6,12 and 24 postnatal weeks

Study Arms (3)

InFat group

ACTIVE COMPARATOR

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

Other: InFat™ based infant formula

Control group

ACTIVE COMPARATOR

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

Other: Standard vegetable oil based infant formula

Referance group

NO INTERVENTION

Human milk breastfeeding

Interventions

InFat™ based infant formula OTHER

high sn-2 palmitic acid oil based infant formula

Also known as: high sn-2 palmitic acid, structured triglyceride

InFat group

Standard vegetable oil based infant formula OTHER

standard vegetable oil based infant formula

Also known as: standard vegetable oil

Control group

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enzymotec: lead
• Biostime, Inc. (Guangzhou): collaborator

Study Sites (1)

Rui Jin Hospital - Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Related Publications (1)

• Bar-Yoseph F, Lifshitz Y, Cohen T, Malard P, Xu C. SN2-Palmitate Reduces Fatty Acid Excretion in Chinese Formula-fed Infants. J Pediatr Gastroenterol Nutr. 2016 Feb;62(2):341-7. doi: 10.1097/MPG.0000000000000971.

  PMID: 26334255 DERIVED

MeSH Terms

Conditions

Health Behavior; Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Xu Chundix, Prof.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: February 13, 2014

Record last verified: 2012-01

Locations

CN (1)