Background: Colostrum is the first milk that supplies newborns with immune supporting peptides. Due to its heterogeneous and variable characteristics, standardized assays for assessment of its biological activities are a challenge. The current set of studies were aimed to investigate the immune activity of bovine colostrum blends as well as develop a method to assess variability across different lots. Methods: Immune activity of a bovine colostrum blend was evaluated by their ability to enhance PBMC (peripheral blood mononuclear cell)-mediated killing of K562 cells. K562 cell killing was assessed by flow cytometry using DAPI. PBMCs derived from multiple healthy donors were initially investigated. Frozen PBMC aliquots from one of the highest responders were used for subsequent studies. Different doses and lots of product were assessed. Incubation time was also explored. Results: Bovine colostrum blend similarly reduced K562 cells number and these effects were often greater than the IL-2 positive control. Despite consistent efficacy at enhancing PBMCs-mediated K562 killing, the degree of the effect was significantly variable across different lots. These biological effects were largely dependent on the solubility of the product. Conclusion: Assessment of PBMC-mediated killing of K562 cells by flow cytometry using DAPI can be a reliable method for measuring immune activity of bovine colostrum when the material is well-dissolved into solution and the same biological sample from a single donor is used.

Sleep disorders, specifically insomnia, are recognized as global public health concerns. The present study is to evaluate the potential effects of a multi-ingredient formula through a multimodal approach on sleep quality in people with insomnia. The study supplement contained bovine colostrum and egg yolk extracts, ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium. Colostrum and egg yolk extracts have been shown to support immune system function and thus likely support sleep health. Ashwagandha root extract, lavender oil, pyridoxal-5-phosphate, melatonin, GABA, and magnesium have been shown to help sleep health and quality via different mechanisms of action. A total of 30 healthy adults with self-reported symptoms of insomnia, divided into placebo and treatment groups, completed a 6-week randomized, double-blinded, placebo-controlled crossover study (1-week washout, 2-week intervention, 1-week washout, and 2-week intervention, sequentially). Participants were instructed to fill out Insomnia Severity Index (ISI) and the Leeds Sleep Evaluation Questionnaire (LSEQ) survey weekly, and keep a sleep diary daily, which were used to assess their sleep quality. Saliva samples were taken from participants before and after each 2-week treatment period to measure salivary melatonin level. Participants were instructed to wear a Fitbit Inspire 2 device to track their sleep and wake data. Linear mixed model ANOVA was used to evaluate statistics for the study. Study supplement significantly improved sleep quality of participants compared to placebo group, specifically difficulty falling asleep (p < 0.01). The study supplement also significantly improved the number of awakenings during the night compared to baseline (p < 0.01). Overall sleep health was improved, specifically sleep quality (wakefulness) (p < 0.01). Study supplement also significantly improved salivary melatonin levels compared to placebo group (p < 0.01). Some limitations of the study include a lack of controlled environment and a heterogeneous population, among others. The preliminary findings observed in the present study showed that the study supplement improved sleep health and quality for people with insomnia. The importance of finding effective and safe solutions for poor sleep and insomnia cannot be overstated. ClinicalTrials.gov NCT05368909 “Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality “, registered May 10, 2022. https://clinicaltrials.gov/study/NCT05368909 .