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Clinical Trials: Nutrition/Metabolism/Exercise
IRB No. 19-206S-1 (Dr. Cato Laurencin, PI): Just Us Moving Program in the State of Connecticut (JUMP-CT)
JUMP-CT aims to increase light physical activity and reduce weight in the African and Hispanic American populations with type 2 diabetes in the greater Hartford region. This program is a simple behavioral modification program focused on decreasing the hemoglobin A1c levels, a marker of blood sugar levels,in diabetics and in turn improving the management of diabetes and its associated complications and risk factors over time.
IRB No. 19-121JS-1 (Dr. Daniel Rosenberg, PI): Ellagic Acid, Urolithins and Colonic Microbial Communities Affected by Walnut Consumption
The purpose of this study is to investigate whether adding walnuts to your diet can have a beneficial effect on your colon. Walnuts contain a natural compound called ellagitannin that is broken down in the stomach to ellagic acid. Ellagic acid is further broken down by your gut microbiota into a group of polyphenolic compounds called urolithins that have powerful anti-inflammatory actions. The gut microbiota is defined as the community of bacteria, fungi, viruses, etc. that live in your gut. Increasing evidence suggests that polyphenol consumption is associated with lower risk of colorectal cancer. We aim to investigate how a person's gut microbiome may contribute to your ability to form these powerful antioxidant urolithin compounds. Antioxidants are a group of substances that have the ability to reduce inflammation. In this study, we will collect demographic information and dietary records, and perform tests on proteins, DNA and/or RNA from samples of colon biopsies, blood, stool and urine to investigate how a person's microbiome may contribute to their ability to form urolithins.
IRB No. 21-001-1 (Dr. Daniel Rosenberg, PI): Determining the Role of Peanut Consumption on Dietary Habits, Gut Microbiome, and Colon Biomarkers in a Healthy Population
Colorectal cancer (CRC) is the second cancer-related cause of death among men and women in the United States. Dietary lifestyle is a contributing factor to CRC risk, and it plays a role in changing the bacteria living in the gut. Current research are now focusing on studying the effects of these bacteria and the compounds they produce, and how it is affecting cancer progression. Peanuts are part of the American diet, a food that is rich in nutrients such as protein, fiber, healthy fats, bioactive compounds, vitamins and minerals. The objective of this study is to determine if increasing peanut intake influences other dietary habits and gut bacteria composition. Secondary aims are as follows: 1) to understand if changes in dietary habits and gut bacteria affect biomarkers in the colon, and 2) to study possible mechanisms in early CRC prevention. Therefore, a dietary intervention will test the effects of peanut intake on dietary habits, gut microbiota, and colon biomarkers. Healthy participants (50-65 years old) scheduled for a screening colonoscopy will be recruited and start a 1-week washout period where they will be asked to avoid peanuts/nuts and other foods provided in a list throughout the study period. Then, they will be randomized into peanut or control group, where control gorup is gender and body mass index matched to peanut group. For 3 weeks, the peanut group will be consuming 2 ounces of roasted peanuts daily, while the control group will not consume peanuts. At baseline and end of clinical trial, blood, stool and 3-day dietary records will be collected. After the intervention, participants will have the colonoscopy done and eight colon biopsy samples will be collected. The hypothesis is that peanut consumption will increase intake of other healthy foods (increase in dietary fiber) and change the bacteria in the gut to a more diverse and rich community when compared to baseline and matched controls. We also expect an increase anti-inflammatory colon biomarker since peanuts contain fiber, unsaturated fats, and antioxidants that may help prevent cancer.
IRB No. 21-167JS-1 (Dr. Daniel Rosenberg, PI): Microbiota, Metabolites and Colon Neoplasia
Dr. Daniel W. Rosenberg and his project Co-Investigators are conducting a research study called ";Microbiota, Metabolites, and Colon Neoplasia"; to examine whether eating walnuts can have a beneficial effect on the gut bacteria population and the tissue that lines the inside of the colon in healthy individuals. Background & Hypothesis The human diet can positively or negatively impact cancer incidence, with plant-derived compounds - such as polyphenols - often exhibiting antioxidant cancer-preventive properties. Walnuts are an exceptional source of polyphenolic ellagitannins (ETs) that are converted to ellagic acid and various urolithins by gut microbiota in the colon. Urolithin A (UroA) is of particular interest for its potent anti-cancer, anti-inflammatory, and prebiotic activities. However, UroA production in individuals can vary significantly, likely based on differences in gut microbiota. We will substantiate the anti-cancer benefits of a prebiotic/probiotic complex derived from consuming walnuts and determine the basis of human inter-individual variability in UroA formation. Our overall hypothesis is that walnut supplementation improves colonic health and lowers colorectal cancer (CRC) risk through UroA formation. Study Design This is a controlled clinical trial to examine the effects of walnuts on CRC risk factors. Rationale While gut associated microbial metabolism of food-derived ETs is correlated with cardiovascular risk biomarkers, ET metabolism and how it relates to CRC risk has not been evaluated. Urolithins affect numerous cell signaling pathways relevant to cancer. The wide range of urolithin bioactivity provides the rationale for studying their potential cancer preventive properties. As part of an ongoing clinical study of early colonic neoplasia, our laboratory optimized ultra-sensitive analytical pipelines to perform a wide range of 'omics' analyses on human mucosal biopsies. This includes our recent study of the 'adherent' microbiome, raising the possibility that microbiota influence early CRC development, a time when prevention strategies are most efficacious. Our newly published findings demonstrate the feasibility of our analytical pipeline and our ability to associate molecular changes in the host colonic mucosa with the microbiota. Ultimately, these human and preclinical mouse studies may lead to the application of prebiotics and probiotics that enhance formation of protective urolithins for CRC prevention. These studies are of high significance as they will test the ability of the microbiota to generate agents (e.g., UroA) protective of the colonic mucosa. It is possible that high-risk patients can be efficiently converted to a protective state by taking probiotics to realize the full benefits of ET-rich foods. Study Population and Sample Size Men or women between the ages of 45-75 years who are scheduled to undergo a routine screening or surveillance colonoscopy for CRC. A total of 1,200 subjects will be enrolled across two sites (UConn Health and Weill Cornell Medicine). Major Study Interventions Subjects will be asked to consume 2 ounces of walnuts daily for 3 weeks prior to their routine colonoscopy. Food surveys, and blood, urine and stool samples will be collected at 2 time points over the course of study participation. A total of 8-10 colon biopsy specimens will be collected during a subject's colonoscopy procedure for the purposes of this study. Main Outcome Measures/Analyses 1) Association of the presence of colon lesions (AAs or SSA/Ps) with UroA production to assess whether UroA is associated with at-risk patients. 2) Identification and isolation of specific bacteria in the microbiome that either promote or impair urolithin synthesis and metabolism, and determine whether they have probiotic activity. 3) We will test whether the consumption of walnuts can elicit beneficial changes to host microbiota and associated functional metabolites (e.g., bile acids [BAs], SCFAs) in human colon. 4) Fecal (or bacterial) microbiome transplants will test for a causal link between UroA formation and cancer protection.