The timing of BB-12 addition to yogurt smoothies in relation to the fermentation process influenced the impact of BB-12 on immune function and cold/flu severity in young healthy adults.

BackgroundSome probiotics have hypocholesterolemic effects in animal studies, which are mediated, in part, by increases in fecal short chain fatty acids (SCFAs). Clinical trials of probiotics on lipids/lipoproteins are inconsistent.ObjectiveWe examined the effects of Bifidobacterium animalis subsp. lactis BB-12® (BB-12®) (3.16 × 109 CFUs/day) on lipids and lipoproteins and fecal excretion of SCFAs in healthy adults.MethodsIn a randomized, partially blinded, 4-period, crossover study, 30 adults (11 men, 19 women) aged 18–40 years were randomly assigned to: 1) yogurt smoothie with no BB-12® (YS), 2) yogurt smoothie with BB-12® added pre-fermentation (PRE), 3) yogurt smoothie with BB-12® added post-fermentation (POST), 4) BB-12® containing capsule (CAP). We measured serum lipids/lipoproteins, glucose, insulin, C-reactive protein (CRP), and fecal SCFAs at baseline and after each treatment period.ResultsTotal cholesterol (TC), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), and triglycerides (TGs) did not differ after the PRE, POST, and CAP periods versus the YS or between treatments. Compared to baseline, fecal acetate was significantly increased after the YS (Δ = 211.89 ± 75.87 μg/g, P = 0.007) and PRE (Δ = 204.98 ± 75.70 μg/g, P = 0.009) periods. The percent increase in fecal acetate was significantly greater after the YS versus the POST period (52.2 ± 13.2% vs. 24.5 ± 13.2%, P = 0.023). Fecal total SCFAs, propionate and butyrate did not differ between treatment periods. Fecal total SCFAs were negatively associated with TC (r = -0.22, P = 0.01), LDL-C (r = -0.24, P = 0.004), age (r = -0.33, P < 0.001), and waist circumference (r = -0.25, P = 0.003).ConclusionsBB-12® supplementation did not improve lipids, lipoproteins and total and individual fecal SCFAs. Fecal SCFAs were negatively associated with TC, LDL-C, age, and waist circumference.Trial registrationThis trial was registered at clinicaltrials.gov as NCT01399996.

These findings not only demonstrate a potential anti-inflammatory effect of BB-12 in healthy adults, but also indicate that the delivery matrix influences the immunomodulatory properties of BB-12.

Objectives Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration (FDA) has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12® (BB-12®)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12®-supplemented yogurt on the gut microbiota of the children. Methods Sixty children aged 1–5 years were randomly assigned to consume four ounces of either BB-12®-supplemented yogurt or non-supplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events. Results A total of 186 non-serious adverse events were reported, with no significant differences between the control and BB-12® groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort. Conclusions BB-12®-supplemented yogurt is safe and well-tolerated when consumed by healthy children. This study will form the basis for future randomized clinical trials investigating the potential effects of BB-12®-supplemented yogurt in different disease states.

Assessment of immune responses in healthy adults following dietary or lifestyle interventions is challenging due to significant inter-individual variability. Thus, gaining a better understanding of host factors that contribute to the heterogeneity in immunity is necessary. To address this question, healthy adults [n = 36, 18–40 years old, body mass index (BMI) 20–35 kg/m2] were recruited. Dietary intake was obtained via 3-day dietary recall records, physical activity level was evaluated using the International Physical Activity Questionnaire, and peripheral blood mononuclear cells were isolated from peripheral blood. Expression of activation markers on unstimulated immune subsets was assessed by flow cytometry. T-cell proliferation and cytokine secretion was assessed following in vitro stimulation with anti-CD3 or lipopolysaccharide. Furthermore, the incidence and severity of cold or flu symptoms were obtained from self-reported upper respiratory tract infection (URTI) questionnaires. The relationship between activation marker expression on T cells and T-cell effector functions; and in vitro cytokine secretion and URTI was determined by linear or logistic regression. CD69 and CD25 expression on unstimulated T cells was significantly associated with T-cell proliferation and interleukin-2 secretion. Incidence and severity of cold or flu symptoms was significantly associated with in vitro interleukin-6 and interferon-gamma secretion, respectively. Furthermore, host factors (e.g., age, BMI, physical activity, and diet) contributed significantly to the relationship between activation marker expression and T-cell effector function, and cytokine secretion and cold and flu status. In conclusion, these results suggest that lifestyle and dietary factors are important variables that contribute to immune responses and should be included in human clinical trials that assess immune endpoints.