NCT01116115

Brief Summary

The purpose of this study is to determine the effect of high sn-2 palmitic acid based infant formula on intestinal parameters in term formula fed infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

April 7, 2010

Last Update Submit

May 16, 2011

Conditions

Health BehaviorDisorder of Growth and Development

Keywords

Term InfantsIntestine floraStool characteristics

Outcome Measures

Primary Outcomes (1)

  • Intestinal flora composition

    infant feces microbial analysis

    Baseline, 5 weeks

Secondary Outcomes (2)

  • Anthropometric measurements

    Baseline, 5 weeks

  • General Health and Well being

    Baseline, 5 weeks

Study Arms (3)

Standard vegetable oil based formula

ACTIVE COMPARATOR
Other: Standard vegetable oil based infant formula

InFat™ based infant formula

ACTIVE COMPARATOR
Other: InFat™ based infant formula

Breast-fed

NO INTERVENTION

Interventions

InFat™ based infant formulaOTHER

High sn-2 palmitic acid oil based infant formula

Also known as: High sn-2 palmitic acid, structured triglyceride
InFat™ based infant formula
Standard vegetable oil based infant formulaOTHER

Standard vegetable oil based infant formula

Also known as: Standard vegetable oil
Standard vegetable oil based formula

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parental/ legal guardian written inform consent
  • The mother had unequivocally decided not to breast-feed (in formula groups) or the mother had decided to breast feed (in human breast milk group).
  • Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
  • Birth weight appropriate for gestational age (AGA).
  • The infant is apparently healthy at birth and entry to study.
  • Apgar after 5 minutes \>7
  • Enrolled within their first 7 days of life
  • The infant is a product of normal pregnancy and delivery, including C-section.
  • Parental ability to attend visits and interviews and willing to fill questionnaires.

You may not qualify if:

  • Mother health condition: (psychological or physical) or socioeconomic problems that may interfere with the mother's ability to take care of her infant or according to PI discretion may interfere with study results.
  • The infant suffers from a major congenital abnormality, a disease or chromosomal disorder with a clinical significance that can be detected at or around birth.
  • The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
  • The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
  • The infant or mother was treated with antibiotics around birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical center

Haifa, Israel

Location

Related Publications (1)

  • Yaron S, Shachar D, Abramas L, Riskin A, Bader D, Litmanovitz I, Bar-Yoseph F, Cohen T, Levi L, Lifshitz Y, Shamir R, Shaoul R. Effect of high beta-palmitate content in infant formula on the intestinal microbiota of term infants. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):376-81. doi: 10.1097/MPG.0b013e31827e1ee2.

    PMID: 23201699DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Arie Riskin, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

IL(1)