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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Health Behavior Disorder of Growth and Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard vegetable oil based formula

Group Type ACTIVE_COMPARATOR

Standard vegetable oil based infant formula

Intervention Type OTHER

Standard vegetable oil based infant formula

InFat™ based infant formula

Group Type ACTIVE_COMPARATOR

InFat™ based infant formula

Intervention Type OTHER

High sn-2 palmitic acid oil based infant formula

Breast-fed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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InFat™ based infant formula

High sn-2 palmitic acid oil based infant formula

Intervention Type OTHER

Standard vegetable oil based infant formula

Intervention Type OTHER

Other Intervention Names

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High sn-2 palmitic acid structured triglyceride Standard vegetable oil

Eligibility Criteria

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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.

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes