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Probiotic

Yogurt smoothie with BB-12 for Metabolic Syndrome (PRO Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)
Awards & highlights

PRO Trial Summary

This trial looks at whether probiotics can help improve gut health by reducing inflammation.

PRO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline before intervention period 1, at endpoint of intervention period 1 (week 4), at baseline before intervention period 2 (week 8), at endpoint after intervention period 2 (week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in inflammatory markers
Secondary outcome measures
Change in gut microbiota populations
Change in gut permeability
Change in metabolism of gut microbiota populations
+1 more
Other outcome measures
Change in serum metabolomic profile
Change in trimethylamine N-oxide (TMAO) in serum

PRO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Participants will consume one yogurt smoothie daily for the duration of the intervention that contains 3.16 × 109 colony forming units (CFU) bifidobacterium animalis subsp. lactis BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.
Group II: ControlPlacebo Group1 Intervention
Participants will consume one yogurt smoothie daily for the duration of the intervention that contains no BB-12. Participants will be asked to refrain from consumption of other yogurt or probiotic-containing foods.

Find a Location

Who is running the clinical trial?

United States Department of Agriculture (USDA)FED
96 Previous Clinical Trials
350,632 Total Patients Enrolled
1 Trials studying Metabolic Syndrome
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
125,717 Total Patients Enrolled
8 Trials studying Metabolic Syndrome
537 Patients Enrolled for Metabolic Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Annual Review of NutritionJournal
Targeting Inflammation-induced Obesity and Metabolic Diseases by Curcumin and Other Nutraceuticals
Aggarwal, Bharat B.. 2010. “Targeting Inflammation-induced Obesity and Metabolic Diseases by Curcumin and Other Nutraceuticals”. Annual Review of Nutrition. Annual Reviews. doi:10.1146/annurev.nutr.012809.104755.
DiabetesJournal
Changes in Gut Microbiota Control Metabolic Endotoxemia-induced Inflammation in High-fat Diet–induced Obesity and Diabetes in Mice
Cani, Patrice D., Rodrigo Bibiloni, Claude Knauf, Aurélie Waget, Audrey M. Neyrinck, Nathalie M. Delzenne, and Rémy Burcelin. 2008. “Changes in Gut Microbiota Control Metabolic Endotoxemia-induced Inflammation in High-fat Diet–induced Obesity and Diabetes in Mice”. Diabetes. American Diabetes Association. doi:10.2337/db07-1403.
bifidobacterium AnimalisJournal
Evaluation of the Immune Benefits of Two Probiotic Strains <i>bifidobacterium Animalis</i> Ssp. <i>lactis</i>, Bb-12<sup>®</sup> and <i>lactobacillus Paracasei</i> Ssp. <i>paracasei</i>, L. Casei 431<sup>®</sup> in an Influenza Vaccination Model: A Randomised, Double-blind, Placebo-controlled Study
Rizzardini, Giuliano, Dorte Eskesen, Philip C. Calder, Amedeo Capetti, Lillian Jespersen, and Mario Clerici. 2011. “Evaluation of the Immune Benefits of Two Probiotic Strains bifidobacterium Animalis Ssp. lactis, Bb-12® and lactobacillus Paracasei Ssp. paracasei, L. Casei 431® in an Influenza Vaccination Model: A Randomised, Double-blind, Placebo-controlled Study”. British Journal of Nutrition. Cambridge University Press (CUP). doi:10.1017/s000711451100420x.
European Journal of NutritionJournal
Consumption of Bifidobacterium Animalis Subsp. Lactis BB-12 in Yogurt Reduced Expression of TLR-2 on Peripheral Blood-derived Monocytes and Pro-inflammatory Cytokine Secretion in Young Adults
Meng, Huicui, Zhaoyong Ba, Yujin Lee, Jiayu Peng, Junli Lin, Jennifer A. Fleming, Emily J. Furumoto, Robert F. Roberts, Penny M. Kris-Etherton, and Connie J. Rogers. 2015. “Consumption of Bifidobacterium Animalis Subsp. Lactis BB-12 in Yogurt Reduced Expression of TLR-2 on Peripheral Blood-derived Monocytes and Pro-inflammatory Cytokine Secretion in Young Adults”. European Journal of Nutrition. Springer Science and Business Media LLC. doi:10.1007/s00394-015-1109-5.
~6 spots leftby Apr 2025
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