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

This study has been completed.
Sponsor:
Information provided by:
Enzymotec
ClinicalTrials.gov Identifier:
NCT01116115
First received: April 7, 2010
Last updated: May 16, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Health Behavior
Disorder of Growth and Development
 Other: InFat™ based infant formula
Other: Standard vegetable oil based infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • Intestinal flora composition [ Time Frame: Baseline, 5 weeks ] [ Designated as safety issue: No ]
    infant feces microbial analysis


Secondary Outcome Measures:
  • Anthropometric measurements [ Time Frame: Baseline, 5 weeks ] [ Designated as safety issue: Yes ]
    Body length, weight, and head circumferences

  • General Health and Well being [ Time Frame: Baseline, 5 weeks ] [ Designated as safety issue: Yes ]
    Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard vegetable oil based formula Other: Standard vegetable oil based infant formula
Standard vegetable oil based infant formula
Other Name: 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:
  • High sn-2 palmitic acid
  • structured triglyceride
No Intervention: Breast-fed

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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116115

Locations
Israel
Bnai Zion Medical center
Haifa, Israel
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Arie Riskin, MD Bnai Zion Medical Center
  More Information

No publications provided by Enzymotec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fabiana Bar-Yoseph, Enzymotec
ClinicalTrials.gov Identifier: NCT01116115     History of Changes
Other Study ID Numbers: InFat_005
Study First Received: April 7, 2010
Last Updated: May 16, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Enzymotec:
Term Infants
Intestine flora
Stool characteristics

Additional relevant MeSH terms:
Palmitic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013