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Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants

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Background: Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life. Methods: The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed. Results: Formula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001). Conclusion: This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes.Trial Registrationclinicaltrials.gov: NCT00666120


Use of dried blood for measurement of trans fatty acids

Background: Fatty acid measurements especially trans fatty acid has gained interest in recent times. Among the various available biomarkers, adipose tissue is considered to be the best for the long term dietary intake but the invasive nature of tissue aspiration reduces its utility. Phlebotomy is a much less invasive method of sample collection when a large number of participants are involved in the study and therefore is an alternative, most suitable for large population based studies. In the present study fatty acid (with special emphasis on trans fatty acid) extraction from blood spotted and dried on filter paper was carried out to simplify the sample collection procedure and transportation. Methods: Blood samples were collected from 19 healthy volunteers. The blood was spotted (30 spots of 10 ?l each) on filter paper, dried at room temperature and stored at 4C in zip-lock poly bags. For comparison whole blood stored at -70C was simultaneously analyzed. Results: A good agreement was seen between trans fatty acid values obtained in dried blood and whole blood as evident from the pearson correlation coefficients ('r' for monounsaturated (trans) 0.70 and for polyunsaturated (trans) 0.692 respectively). The intraclass correlation coefficient for monounsaturated trans was 0.805 and for polyunsarurated trans was 0.776. Conclusion: Dried blood spots can be used for trans fatty acid analysis.