Abstract
Objectives: The pig is a common model utilized to support substantiation of novel bioactive components in infant formula. However, reference ranges for outcomes to determine safety are unclear. Our objective was to use historical data to objectively define typical body and organ growth metrics of the domesticated pig in research.Methods: Twenty-two studies were compiled to assess typical growth of body and organ weights in young pigs. Metadata were organized to include milk replacer sources, bioactive components, sex, breed, source of herd, feeding regimen, and rearing environment. A combination of statistical models including simple linear regression and linear mixed effect models were used to assess typical growth patterns.Results: Over 18,000 data points from 786 animals were available. In general, minimal differences in the growth of pigs who were male and female, artificially- or sow-reared, or fed ad libitum- or by scheduled-feeding, were observed in the first 30 days of life (P > 0.05). A weight-for-age chart from reference pigs was developed to compare body weights of pigs demonstrating growth characterized as accelerated, typical, reduced, and failure to thrive to illustrate effects of dietary interventions. Distributions of relative brain, liver, and intestine weights (as % of total body weight) were similar between rearing environments and sexes. An alternative bivariate level approach was utilized for the analysis of organ weights. This approach revealed significant biologically-relevant insights into how deficient diets can affect organ weight that a univariate level assessment of weight distribution was unable to detect.Conclusions: Ultimately, these data can be used to better interpret whether bioactive ingredients tested in the pig model affect growth and development within typical reference values for pigs in the first 30 days of life.
Highlights
The National Academy of Medicine, formerly named The Institute of Medicine (IOM), provided guidelines on considerations to make in the testing of safety and quality of ingredients in infant formula [1]
The European Food and Safety Administration (EFSA) provided guidance promoting the use of a neonatal pig model for a repeated dose study with direct oral administration for the study of non-absorbed substances intentionally added to foods for infants below 16 weeks of age [2]
While the data used in this modeling exercise were generated in the context of nutritional studies on infant formula, they may be used for any research context that can benefit from typical growth reference ranges using the domestic pig in research
Summary
The National Academy of Medicine, formerly named The Institute of Medicine (IOM), provided guidelines on considerations to make in the testing of safety and quality of ingredients in infant formula [1] They stated that preclinical studies are a necessary component of safety testing, but that rodent models were not recommended due to the difficulty of conducting nutritional studies on pre-weaning rodents. The artificially-reared pig is a common model utilized in pediatric nutrition research as it allows for control of nutritive intake when testing the effects of various dietary ingredients Examples of this model in the literature include assessments of the safety and efficacy of milk fat globule membrane [6], soy- vs dairy-based formulas [7], human milk oligosaccharides [8], and fortification of donor milk for preterm models [9]
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