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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116115
• Other study ID #: InFat_005
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: May 16, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Disorder of Growth and Development
• Health Behavior

Intervention

Other:
• InFat™ based infant formula
High sn-2 palmitic acid oil based infant formula
• Standard vegetable oil based infant formula
Standard vegetable oil based infant formula

Locations

Country	Name	City	State
Israel	Bnai Zion Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal flora composition	infant feces microbial analysis	Baseline, 5 weeks	No
Secondary	Anthropometric measurements	Body length, weight, and head circumferences	Baseline, 5 weeks	Yes
Secondary	General Health and Well being	Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report	Baseline, 5 weeks	Yes