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[Evaluation of a local infant formula enriched with polyunsaturated fatty acids produced in Israel]
Z Weizman1, E Brutman, D Leader
1Pediatric Gastroenterology Dept., Ben-Gurion University of the Negev, Beer Sheba.
Insights
A new locally-made polyunsaturated fatty acids (PUFA) enriched infant formula was found safe and effective in a 30-day study. The formula showed no significant differences in growth or infant behavior compared to standard formula.
Area of Science:
- Nutrition Science
- Pediatric Health
- Clinical Research
Background:
- Polyunsaturated fatty acids (PUFA) are essential for infant brain and eye development.
- Breast milk is a primary source of PUFA, compensating for low infant synthesis.
- Commercial infant formulas are increasingly fortified with PUFA.
Purpose of the Study:
- To assess the safety and clinical efficacy of a novel, locally produced PUFA-enriched infant formula.
- To compare a PUFA-enriched formula against a standard formula in healthy infants.
Main Methods:
- A prospective, randomized, double-blind study involving 50 healthy, full-term infants over 30 days.
- Infants received either a standard whey-predominant formula or a PUFA-enriched formula.
- Evaluations included physical exams, growth parameters, stool analysis, parental questionnaires, and developmental assessments.
Main Results:
- No significant differences were observed between the groups in growth parameters, infant behavior, or stool characteristics.
- No adverse side effects or abnormal stool findings were reported in either group.
- Developmental assessments at 3 months showed no differences between infants fed standard or PUFA-enriched formula.
Conclusions:
- The locally produced PUFA-enriched infant formula is safe and clinically effective for infants.
- The short study duration may explain the lack of observed developmental effects.
- PUFA supplementation remains crucial for optimal infant brain and eye development based on existing literature.
Abstract:
Polyunsaturated fatty acids (PUFA) are vital for the normal development of the brain and the eye retina in infancy. Breast milk contains significant amounts of PUFA, and compensates for their low production in infancy. Only recently a few companies with worldwide product distribution have started to enrich infant formula with PUFA. We evaluated the safety and clinical efficacy of a locally made PUFA-enriched infant formula, produced for the first time in Israel. 50 normal, full term infants participated in a prospective, randomized double-blind study. Half received a regular whey-predominant infant formula (Materna Plus), and the other half a PUFA-enriched formula (Materna Premium), both produced in Israel, for 30 days. Evaluation included physical examination, growth parameters, stool analysis, daily parental questionnaires regarding infant behavior and defecation, and developmental assessment. There were no significant differences on comparing growth parameters, infant behavior, attacks of restlessness, gas severity, or stool characteristics in the 2 groups. There were no side effects or abnormal stool findings in either group, and no differences in developmental assessment at 3 months of age. We conclude that the locally-produced PUFA-enriched infant formula is safe and clinically efficient. We assume that the lack of any effect on developmental indices is due to the relatively short exposure to the PUFA-enriched diet. Nevertheless, based on the recent literature, there is no doubt that PUFA supplementation is vital in improving infant brain and eye development.