Clinical trial NCT01116115: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters in Infants (InFat_005)
Official title: The Effects of Dietary Palmitic Acid Triacylglyceride Position on Intestinal Parameters, Anthropometric Parameters and Stool Characteristics in Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Disorder of Growth and Development
Keywords: Term Infants
Intestine flora
Stool characteristics
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 30
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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.

Primary outcomes:
measure: Intestinal flora composition
timeFrame: Baseline, 5 weeks
Secondary outcomes:
measure: Anthropometric measurements
timeFrame: Baseline, 5 weeks
measure: General Health and Well being
timeFrame: Baseline, 5 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical center
Study officials:
affiliation: Bnai Zion Medical Center
name: Arie Riskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yaron S, Shachar D, Abramas L, Riskin A, Bader D, Litmanovitz I, Bar-Yoseph F, Cohen T, Levi L, Lifshitz Y, Shamir R, Shaoul R. Effect of high beta-palmitate content in infant formula on the intestinal microbiota of term infants. J Pediatr Gastroenterol Nutr. 2013 Apr;56(4):376-81. doi: 10.1097/MPG.0b013e31827e1ee2.