Healthy
Conditions
Keywords
infant, infant formula, fatty acids, palmitic acid, stool, calcium
Brief summary
The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.
Detailed description
In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption. Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions. Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula. InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position. The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.
Interventions
BEHAVIORALInfant formula feeding (InFat™)
Infant formula with InFat™ oil (containing \ 49% of C16:0 at sn-2 position), 24 wk
DIETARY_SUPPLEMENTControl
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
1 Days to 8 Days
Healthy volunteers
Yes
Inclusion criteria
* Term infants: gestation 37-40 weeks * Birth weight 2500-4000 g * Apparent good health * The infant is a product of normal pregnancy and delivery.
Exclusion criteria
* Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant * Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant * Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis) * Born with a 5- or 10-minute Apgar score \<7 * Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula) * Breast-feeding for a week or over. * Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool biochemistry - soaped fatty acids | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Stool biochemistry - total fatty acids and calcium content | 6 weeks |
| Stool characteristics - 7days diaries | 3 months |
| General health | 3 months |
| Anthropometric parameters | 3-6 months |
Countries
China
Outcome results
None listed