Skip to main content
OpenTrials
Completed

NCT Number: NCT01116115

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical center

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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. Intestinal flora composition

    Time frame: Baseline, 5 weeks

    infant feces microbial analysis

Secondary outcomes

  1. Anthropometric measurements

    Time frame: Baseline, 5 weeks

    Body length, weight, and head circumferences

  2. General Health and Well being

    Time frame: Baseline, 5 weeks

    Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report

Sponsors and collaborators

Lead sponsor

Enzymotec

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 4, 2010
Registry last updated
May 17, 2011

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.

Published trials that share one or more normalized conditions with this study.