The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)

May 16, 2011 updated by: Enzymotec

The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

InFatTM is an advanced basic-fat ingredient, which mimics the fat composition and properties of human milk fat and enabling optimal intake of the essential calcium and energy (in the form of fatty acids) and easy digestion. These benefits are the result of a unique fatty acid composition on the glycerol backbone, which ensures high level of palmitic acid at the middle (sn-2) position.

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Bnai Zion Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Parental/ legal guardian written inform consent
  2. 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).
  3. Term infants of born at 37-42 gestation weeks as determined by menstrual history and corroborated by prenatal US and/or physical examination.
  4. Birth weight appropriate for gestational age (AGA).
  5. The infant is apparently healthy at birth and entry to study.
  6. Apgar after 5 minutes >7
  7. Enrolled within their first 7 days of life
  8. The infant is a product of normal pregnancy and delivery, including C-section.
  9. Parental ability to attend visits and interviews and willing to fill questionnaires.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. The infant suffers/ed from a disease requiring mechanical ventilation or medication treatment at the first week after birth.
  4. The infant suffers from any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula).
  5. The infant or mother was treated with antibiotics around birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Breast-fed
ACTIVE_COMPARATOR: Standard vegetable oil based formula
Other: Standard vegetable oil based infant formula
Standard vegetable oil based infant formula
Other Names:
  • Standard vegetable oil
ACTIVE_COMPARATOR: InFat™ based infant formula
Other: InFat™ based infant formula
High sn-2 palmitic acid oil based infant formula
Other Names:
  • structured triglyceride
  • High sn-2 palmitic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal flora composition
Time Frame: Baseline, 5 weeks
infant feces microbial analysis
Baseline, 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measurements
Time Frame: Baseline, 5 weeks
Body length, weight, and head circumferences
Baseline, 5 weeks
General Health and Well being
Time Frame: Baseline, 5 weeks
Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report
Baseline, 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzymotec

Investigators

  • Principal Investigator: Arie Riskin, MD, Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (ESTIMATE)

May 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InFat_005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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