In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.
Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act independently of the matrix used to deliver them to the human host. This thinking ignores the impact the delivery matrix (food or dietary supplement) may have on both the physiology of the probiotic organism and on the human host and is likely not true. Historically the most common "probiotic foods" have been fermented dairy products, particularly yogurts. Since yogurts are commonly understood to contain live "good" bacteria they are well accepted by consumers. However, increasingly over the last decade, probiotics are being added to non-dairy-based foods (juice, chocolate, cookies, etc) or consumed as supplements (tablets/capsules). While this expands the options for people to obtain probiotic organism, it is not clear whether probiotics delivered in these products are as efficacious as when delivered in a dairy food. In fact, the buffering capacity and nutrient composition of milk products may directly influence efficacy of the probiotic by increasing survival during passage through the gastrointestinal tract (GIT) and by modifying the physiology of the probiotic organism. In addition, fermentation products produced by the probiotic during manufacture of yogurt may also have an influence on the efficacy of probiotic bacteria. Our hypotheses are: 1. The vehicle used to deliver probiotic bacteria into the body influences the performance of the probiotic in vivo. Specifically, consumption of yogurt-based smoothie containing probiotic bacteria will result in greater decrease in fecal transit time, and have a greater effect on the composition of the fecal microbiota and on markers of immune status than the same probiotic bacteria delivered at the same level in the form of a dietary supplement (tablet). 2. Timing of the addition of probiotic organism to the yogurt smoothie (pre or post fermentation) will not change the efficacy of the probiotic with respect to the outcomes being assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
36
A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
A daily 8 oz (240 mg) serving will provide 10x\^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
A capsule taken daily will provide between 10x\^y9 and 10x\^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
Penn State University
University Park, Pennsylvania, United States
Gastrointestinal transit time
Gastrointestinal transit time is the amount of time it takes for food to travel through the digestive tract to be excreted. It will be measured using the SmartPill wireless motility capsule.
Time frame: Weeks 4, 10, 16, 22
Change from baseline in the fecal microbiota profile at 4 weeks following each of the 4 interventions and 1 free living period
Time frame: Weeks 4, 10, 16, 22 and 28
Change from baseline in immune status at 4 weeks following each of the 4 interventions and 1 free living period
Time frame: Weeks 4, 10, 16, 22, 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.