Progress 07/01/17 to 06/30/23
Outputs
Target Audience:The target audience was twofold: 1) the scientific community and 2) the lay public. First the scientific community will benefit from the knowledge gained after conducing this research. A better understanding the role of probiotic supplemented yogurt in reducing obesity-induced inflammation, changes in gut permeability, and microbiome in older adults has been gained. Second, knowledge gained from this project can be translated into recommendation for the general public about the use of probiotic consumption to reduce inflammation in this population. Inflammation underlies many chronic disease, thus this knowledge and application may result in significant health benefits. Changes/Problems: This project had a recommended start date of March 1, 2017. I submitted an institutional review board (IRB) protocol in January of 2017. The Penn State IRB required us to contact the FDA to determine if we needed and investigational new drug application (IND) since were we feeding subjects yogurt with probiotics, which may be perceived as a drug. I've included our correspondence with the FDA and our IRB which took place over the course of 2017 to document this obstacle. We did not get permission to use the yogurt with probiotic from the FDA and subsequent IRB approval until March of 2018. We experienced slow recruitment in the first year of the study because one of our exclusion criteria was the use of statins. Over 70% of subjects in this age category are on statins, so we expanded our recruiting radius from local communities near the University (blue circle) to surrounding communities (red circle), and widened the age bracket for inclusion. Penn State experienced a COVID-related research shutdown for 15 months (March 2020-June 2021) during the project funding period, and as a consequence, we suffered a loss of data from 34 participants. Specifically, our enrollment numbers are explained below: We completed 8 subjects in 2018 (late start b/c of FDA delays described above); had 1 drop out Completed 19 people in 2019 up to Nov 2019; had 1 drop out. Had 8 subjects scheduled to start in Jan 2020; 14 scheduled to start in Feb of 2020, and 12 scheduled to start in March of 2020 (only 2 actually started in March 2020). Lost treatment 2 data collection on 8 subjects with Jan 2020 start. Only 3 of the 14 with Feb start finished treatment 1 by the time the University research shut down occurred in March 2020; the remaining 11 with a Feb 2020 start date and 12 with March start date could not complete treatment 1, and dropped out of the study. We completed 6 subjects in 2021. (We only could start recruiting again in July of 2021). We enrolled 6 subjects in Feb 2022, 8 subjects in March, and 14 subjects in April. 4. We experienced significant regulatory delays with the Penn State IRB and were unable to recruit the recommendation number of subjects to the trial. What opportunities for training and professional development has the project provided?The project has provided the opportunity to train undergraduate and graduate students in clinical and translational research. Furthermore, this project has given them the opportunity to interface with clinical staff in the Clinical Reseach Center, as part of the Clinical and Translational Science Institute at Penn State University. How have the results been disseminated to communities of interest?Students have presented results of this study at local and national meetings, and two manuscripts have been published in peer reviewed journals. What do you plan to do during the next reporting period to accomplish the goals?
Nothing Reported
Impacts
What was accomplished under these goals?
Probiotics have the potential to influence host inflammatory responses via direct modulation of the immune system, which may in turn, translate into a reduction in systemic inflammation. Probiotics may also alter intestinal permeability and gut microbiota, which could impact systemic inflammatory signals. These three physiologic responses are interrelated and the effect of BB-12 consumption on any one of these endpoints may influence the other. Therefore, the focus of this proposal was to determine if consumption of BB-12 in yogurt is reducing systemic inflammatory mediators by directly .down regulating inflammatory signaling pathways, altering gut permeability and/or modulating gut microbiota. This project explored these questions through a collaborative effort at the interface of nutrition, food science and microbiology, and contributed to a better understanding of the effects of BB-12 on inflammatory processes and gut health. Furthermore, results from this project will contribute to our understanding of the impact on BB-12 consumption on human health and chronic disease prevention.
Publications
- Type:
Journal Articles
Status:
Published
Year Published:
2023
Citation:
Van Syoc EP, Damani J, DiMattia Z, Ganda E, Rogers CJ. The Effects of Bifidobacterium Probiotic Supplementation on Blood Glucose: A Systematic Review and Meta-Analysis of Preclinical Animal Models and Clinical Evidence.Adv Nutr. 2023 Nov 2:S2161-8313(23)01398-4. doi: 10.1016/j.advnut.2023.10.009. Online ahead of print. PMID: 37923223
- Type:
Journal Articles
Status:
Accepted
Year Published:
2023
Citation:
DiMattia, Z., Damani, J.J., Van Syoc, E., Rogers, C.J. Effect of probiotic supplementation on intestinal permeability in overweight and obesity: A systematic review of randomized controlled trials and preclinical studies, in press.
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Progress 07/01/21 to 06/30/22
Outputs
Target Audience:The target audience reached on this grant during this reporting period were scientists, students and the general public. We continued to work closely with our clinical research center staff to recuit subjects following all safetly measures instituted post COVID for human subjects research. We continued to vigoruosly recruit subjects on this trial thus were interfacing with the general public explaining the goals of the trial to interested subjects. Changes/Problems:No changes in approach from last reporting period. What opportunities for training and professional development has the project provided?I have one graduate student and three undergraduate students working on data collection for this trial. The graduate student received a university fellowship and the undergraduate students are getting research credits to work on the project. How have the results been disseminated to communities of interest?Results of this clinical trial will be disseminated upon completion of the trial. What do you plan to do during the next reporting period to accomplish the goals?I am requesting an additional no cost extension on the grant to i) complete the existing subjects enrolled on the trial in April of 2022 (we need to reimburse subjects for participating in the trial); ii) pay for the cost of analyses of the major endpoints on the trial including cytokine multiplex assays, gas chromatographic analyses of urine, and microbiome analyses. These endpoints are being run at the end of the trial to prevent inter-assay variability. And, iii) pay for manuscript publication fees. We have made significant progress on this trial despite a number of obstacles out of our control. 26 subjects completed the trial; and biological endpoints have been collected and stored for assessment. An additional 12-month extension on this grant will allow us to complete the aims proposed, publish our important findings and fulfill our obligation to the USDA to complete the project.
Impacts
What was accomplished under these goals?
Penn State experienced a COVID-related research shutdown for 15 months (March 2020-June 2021) during the project funding period, and as a consequence, we suffered a loss of data from 34 participants. We completed 6 subjects in 2021. (We only could start recruiting again in July of 2021). We enrolled 6 subjects in Feb 2022, 8 subjects in March, and 14 subjects in April.
Publications
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Progress 07/01/20 to 06/30/21
Outputs
Target Audience:Our target audience during the reporting period were scientists and the general public. We have worked closely with our clinical research center at Penn State to facilitate recruitment of subjects according to COVID protocols. We have recruited subjects onto the trial thus have interfaced with the general public during the screening process. Changes/Problems:We experienced slow recruitment after the COVID research shut down, so we continued to expand our recruiting radius from local communities near the University to surrounding communities, and widened the age bracket for inclusion. What opportunities for training and professional development has the project provided?I am training one graduate student and three undergradaute students by working on the trial. They are not listed on the FTE report because the graduate student has a university fellowship and the undergraduate students are assisting for research credits. How have the results been disseminated to communities of interest?Not in this funding period. Results will disseminated at the end of the trial. What do you plan to do during the next reporting period to accomplish the goals?We will i) complete the existing subjects enrolled on the trial; ii) complete the analyses of the major endpoints on the trial including cytokine multiplex assays, gas chromatographic analyses of urine, and microbiome analyses. We have made significant progress on this trial despite a number of obstacles out of our control.
Impacts
What was accomplished under these goals?
Penn State experienced a COVID-related research shutdown for 15 months (March 2020-June 2021) during the project funding period, and as a consequence, we suffered a loss of data from 34 participants. We 8 subjects scheduled to start in Jan 2020; 14 scheduled to start in Feb of 2020, and 12 scheduled to start in March of 2020 (only 2 actually started in March 2020). Lost treatment 2 data collection on 8 subjects with Jan 2020 start. Only 3 of the 14 with Feb start finished treatment 1 by the time the University research shut down occurred in March 2020; the remaining 11 with a Feb 2020 start date and 12 with March start date could not complete treatment 1, and dropped out of the study.
Publications
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Progress 07/01/19 to 06/30/20
Outputs
Target Audience:We performed the microbiota analyses on six subjects on the trial to guide future analyses. However Human Subjects Research was halted at our University from March 2020-March 2021 so no additional progress has been made. Changes/Problems:We have submitted a modification to our Institutional Review Board to expand the eligibility criteria of the trial. This includes accepting a wider age range, and a loosening of the restrictions on prescription drug use for subjects on the trial. We do not believe this will compromise the science, but will allow us to speed up recruitment following the COVID-19 research shutdown at our university. What opportunities for training and professional development has the project provided?
Nothing Reported
How have the results been disseminated to communities of interest?
Nothing Reported
What do you plan to do during the next reporting period to accomplish the goals?We have received institutional approval to resume the clinical trial. We will ramp up recruitment and data collection with the goal of completing the trial in the next reporting period.
Impacts
What was accomplished under these goals?
We have microbial analysese completed on six subjects. All other outcomes will be evaluated at the completion of the RCT.
Publications
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Progress 07/01/18 to 06/30/19
Outputs
Target Audience:The target audience reached by our efforts on this grant during this reporting period were scientists, clinicians, and the general public. We worked closely with scientists, clinicians, and regulatory personnel to obtain IRB approval for the project. We have also worked with the general public to advertise and recruit for our study. Changes/Problems:We have had difficulty recruiting subjects who meet are eligibility criteria in the State College area. We have recently expanded our recruitment efforts to surrounding communities (75 mile radius) and expect recruitment to increase. What opportunities for training and professional development has the project provided?I have a PhD student working on subject recruitment and sample analysis. How have the results been disseminated to communities of interest?Not yet. This will be done upon trial completion. What do you plan to do during the next reporting period to accomplish the goals?We will continue to actively recruit subjects for the trial, and will continue data analysis.
Impacts
What was accomplished under these goals?
We are still actively recruiting subjects for the study. We have collected complete data on 8 subjects, and have 4 more subjects on study. We have expanded our recruiting radius to increase the accural rate on the trial. All we have analysed the microbiome data on the first 6 subjects, and have the cytokine supernatants and urine samples frozen for analyses upon completion of the trial.
Publications
- Type:
Journal Articles
Status:
Submitted
Year Published:
2019
Citation:
N/A
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Progress 07/01/17 to 06/30/18
Outputs
Target Audience:The target audience reached by our efforts on this grant during this reporting period were scientists, clinicians, and the general public. We worked closely with the FDA to determine if we needed an IND prior to obtaining IRB approval. We then worked with scientists and clinicians to obtain IRB approval for the project. Lastly, we have now started working with the general public to advertise and recruit for our study. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?The project has enabled me to train two students (graduate and undergraduate) in data collection and analysese methods related to the project. I attended the Program Directors meeting in June of 2018 and had the opportunity to discuss the project and form new potential collaborations with other PDs. How have the results been disseminated to communities of interest?This has not occurred yet in this reporting period as we only have begun participant recruitment. What do you plan to do during the next reporting period to accomplish the goals?We will contine to recruit subjects, collect data, and plan to present preliminary findings at both the program directors meeting and the American Society for Nutrition annual conference.
Impacts
What was accomplished under these goals?
We have obtained an exception to submit an IND for this work from the Food and Drug Administration. We have obtained IRB approval at Penn State for the proposed study. We have begun participant recruitment. I have trained the graduate student and undergraduate student working on the project to collect data on all study outcomes.
Publications
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