Disorder of Growth and Development, Health Behavior
Conditions
Keywords
Term Infants, Intestine flora, Stool characteristics
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.
Interventions
High sn-2 palmitic acid oil based infant formula
Standard vegetable oil based infant formula
Sponsors
Enzymotec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intestinal flora composition | Baseline, 5 weeks | infant feces microbial analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measurements | Baseline, 5 weeks | Body length, weight, and head circumferences |
| General Health and Well being | Baseline, 5 weeks | Physical examinations, Health (dieases, doctor visits) and well being (sleeping, crying) questionnaires, medications report |
Countries
Israel
Outcome results
None listed