Progress 06/01/17 to 05/31/21
Outputs
Target Audience:
Nothing Reported
Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?Dr. Hongwei Si (Tennessee State University) received an award (2018-38821-27733) from the National Institute of Food and Agriculture for "Professional Development in microRNA and Nutrition Research Using Human Subjects." He has continued working with our group and he is receiving training on microRNA measurement and statistical analyses and the preliminary ancillary results indicated above belong to this activity. How have the results been disseminated to communities of interest?Additional statistical and laboratory analyses are being conducted before dissemination to the communities of interest in the form of peer-reviewed publications and presentations at scientific meetings. What do you plan to do during the next reporting period to accomplish the goals?Although this is the final report, there is a need to complete laboratory analyses that were not carried out due to the pandemic restrictions. Moreover, the delay in getting data has also brought up delays in completing the statistical analyses in progress. Nevertheless, as shown by the analyses carried out so far, the body of evidence from this work will be of great interest to the scientific community, especially those involved in precision nutrition.
Impacts
What was accomplished under these goals?
Since the inception of the study, we have contacted 574 potential participants. Of those, 243 went to the first screen and the APOA2 genotype was performed on all of them to identify those who were eligible to participate in the study. These are carriers of the CC or TT genotypes. Seventy-five were identified with those genotypes, and forty-one subjects were selected and randomized to the study. Of those, 36 have already completed the study and five were discontinued. We accomplished the proposed goals of completing some of the four groups (10 TT males, 10 TT females) and we incentivized the efforts to complete the less common groups (10 CC males and 10 CC females). We have completed the intervention study for 16 of them. Since March 2020, we have had to interrupt recruitment and intervention. Therefore, we submitted the existing samples (20 TT and 16 CC) for laboratory measurements (NMR metabolomics) to a commercial laboratory and a collaborating laboratory operating during certain periods of the pandemic. Data was received and initial statistical analyses were carried out. The NMR metabolomic analyses show a very significant effect of dietary intervention on the response of key lipid-related biomarkers. Still, it did not have a statistically significant impact on glucose- and inflammation-related biomarkers. Moreover, according to the pre-existing hypothesis, the affected lipid-related biomarkers' response to the plant-based diet tended to be more pronounced (more statistically significant) in CC subjects than in TT subjects. However, the hypothesis could not be proven for glucose- and inflammation-related biomarkers. Principal component analyses (PCA) of the lipidomic data show a similar pattern to those seen for the metabolomic data. The global diet response for key metabolites was much more significant than the genotype effect on the response of those metabolites. Nevertheless, several CC subjects showed as outliers and this deserves further investigation to identify the reasons for that individuality. An important outcome of these results (metabolomics and lipidomics) is that lipid metabolism is very responsive to diet (in days) versus the traditional belief of the need for weeks of intervention. Therefore, in summary, the data so far demonstrates that: the type (animal versus plant)/time (1 week) resulted in very significant changes in lipid metabolism (as shown by NMR metabolomics and lipidomics), but not so for glucose- and inflammation-related biomarkers. Moreover, there was an increased response to the plant diet, compared to the animal diet, in CC carriers than in TT carriers for lipid-related traits. However, just like for the main effects, no gene-diet interactions were noted for glucose- and inflammation-related traits. As an ancillary study, we were able to measure non-coding RNAs, such as microRNAs (miRNAs), small nucleolar RNA (snoRNAs), and Piwi-interacting RNA (piRNAs). Data analyses for this study are ongoing. However, preliminary analyses have identified several non-coding RNAs that are responsive to diet. Due to the pandemic, we could not yet generate data on the microbiome; however, we have extracted the microbial DNA from the stools collected and they are now being readied for analysis.
Publications
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Progress 06/01/19 to 05/31/20
Outputs
Target Audience:Potential volunteers who are willing to participate in the study. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?Dr. Hongwei Si (Tennessee State University) received an award (2018-38821-27733) from the National Institute of Food and Agriculture for "Professional Development in microRNA and Nutrition Research Using Human Subjects." He has continued working with our group and he is receiving training on microRNA measurement and statistical analyses. 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?On March 17, 2020 due to the COVID-19 pandemic, the Human Nutrition Research Center on Aging at Tufts University transitioned all research operations to a virtual workplace to avoid face-to-face interactions. Given the nature of our human subjects' study which requires face-to-face meetings, it is temporarily suspended until further guidance. Study participant recruitment will restart as soon as the research center resumes operations and it is safe for our study participants to come to the Center for study-related measurements. Currently, the exact date of reopening remains unclear. However, once the study resumes, every effort will be made to accelerate recruitment to catch up for lost time to complete the dietary intervention on as many of the remaining subjects as possible. During the requested extension period, we will try to complete the dietary intervention on as many subjects as possible, to complete the proposed laboratory measurements and to complete the statistical analyses.
Impacts
What was accomplished under these goals?
Up to May 12, 2020, these are the accomplishments: During this reporting period, several amendments to the initially approved IRB were filed and approved. Since the inception of the study, we have contacted 574 potential participants. Of those, 243 went to the first screen and the APOA2 genotype was performed on all of them to identify those who were eligible to participate in the study. These are carriers of the CC or TT genotypes. Seventy-five were identified with those genotypes, and forty-one subjects were selected and have been randomized to the study. Of those, 36 have already completed the study and five were discontinued. We accomplished the proposed goals of completing some of the four groups (10 TT males, 10 TT females) and we incentivized the efforts to complete the less common groups (10 CC males and 10 CC females). We have completed the intervention study for 16 of them. Currently we had to interrupt recruitment and intervention for an unknown period of time. Therefore, while this possibility was still available, laboratory measurements (NMR metabolomics) was conducted by a commercial laboratory on the 36 subjects (20 TT and 16 CC) that have completed the study and the data are being processed for statistical analyses that will began during the next 2-weeks.
Publications
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Progress 06/01/18 to 05/31/19
Outputs
Target Audience:Potential volunteers who are willing to participate in the study. Changes/Problems:
Nothing Reported
What opportunities for training and professional development has the project provided?Dr. Hongwei Si (Tennessee State University) received an award (2018-38821-27733) from the National Institute of Food and Agriculture for "Professional Development in microRNA and Nutrition Research Using Human Subjects." He has visited the HNRCA and received training on the conduct of research using human subjects as stipulated in his project. 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?During the next period, we will complete the dietary intervention on nine subjects, and with that, we will accomplish our recruitment objective of 40 subjects (10 TT males, 10 TT females and 10 CC males and 10 CC females). Once all the participants have completed the dietary study and all the biological samples have been collected; then we will carry out of the proposed laboratory measurements.
Impacts
What was accomplished under these goals?
Up to February 28, 2019, these are the accomplishments: During this reporting period, several amendments to the initially approved IRB were filed and approved. Since the inception of the study, we have contacted 411 potential participants. Of those 180 went to the first screen and APOA2 genotype was performed on all of them to identify those who were eligible to participate in the study. These are carriers of the CC or TT genotypes. Sixty-seven were identified with those genotypes, and thirty-five subjects were selected and have been randomized to the study. Of those 31 have already completed the study and four were discontinued. The recruitment efforts are according to the expectations. We accomplished the proposed goals of completing some of the four groups (10 TT males, 10 TT females) and we incentivized the efforts to complete the less common groups (10 CC males and 10 CC females), and we have completed the intervention study for 11 of them. This sums to 31 subjects having completed the dietary intervention study. We did not conduct laboratory measurements at this point as we considered that to minimize batch to batch variation on the analytics it will be much more appropriate to conduct all the assays once all the samples have been collected.
Publications
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Progress 06/01/17 to 05/31/18
Outputs
Target Audience:Potential volunteers who are willing to participatein the study. Changes/Problems:
Nothing Reported
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?During the next period, we will be able to achieve full recruitment for some of the 4 groups (10 TT males, 10 TT females and we will incentivize the efforts to complete the less common groups (10 CC males and 10 CC females). To minimize technical variability, laboratory measures will take place in batches and the first one will be carried out once 50% of the targeted number of participants has completed the study.
Impacts
What was accomplished under these goals?
Up to March1, 2018, these are the accomplishments: The initial objective of this reporting period was to prepare the documentation for IRB approval of the proposed human randomized trial. This was accomplished and the study protocol was approved by the local IRB. Since its approval, we have contacted 188 potential participants. Of those 73 went to the first screen and APOA2 genotype was performed on all of them to identify those who were eligible to participate in the study. These are carriers of the CC or TT genotypes. Twenty-nine subjects were selected and 18 have been randomized to the study. Of those 7 have already completed the study and one was discontinued. The recruitment efforts are according to the expectations.
Publications
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