[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06117241":3,"trial-entities:NCT06117241":82,"trial-summary:NCT06117241":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":79,"references":80,"see_also_links":81},"NCT06117241","Pro00120270","Reducing Metabolic Dysregulation in Dyads","A Transdisciplinary Approach to Investigating Metabolic and Risk of Early-Onset Colorectal Cancer: A Randomized Intervention Trial in Human Dyads and Mechanistic Study in Animals","RECRUITING","2028-03-31","2026-01","2026-01-29","2023-10-17","University of South Carolina","OTHER",true,"This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg\u002Fm2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use. Their partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use.","This project leverages our expertise in the epidemiology of colorectal cancer (CRC); disparities; obesity; metabolic dysregulation, an important manifestation of inflammation; the microbiome; animal CRC models; and lifestyle intervention trials to address the growing problem of Early-Onset CRC (EOCRC) (i.e., \\\u003C50 years). Adiposity and diet drive metabolic dysregulation. So, understanding the interaction between diet and adiposity are key to understanding the genesis of EOCRC - and an array of other obesity-related cancers. This project will address the absence of critical clinical trials and mechanistic studies involving lifestyle interventions for EOCRC. We intend to address this gap; and have the transdisciplinary team representing complementary backgrounds to do so. We focus on dietary modulation of gut microbes to reduce metaflammation and subsequent metabolic dysfunction in obesity, with a goal of preventing EOCRC. We will perform an anti-inflammatory dietary intervention trial in dyads of adults and children at elevated risk for CRC. We also will conduct a complementary mechanistic animal study that builds on and leverages our expertise in mechanistic studies on obesity and CRC. This work is supported by infrastructure that we have built over the past decades in two key centers at the University of South Carolina (USC): (1) Center for Colon Cancer Research (CCCR, 2002 - present - which specializes in mouse models of CRC); and (2) the Cancer Prevention and Control Program (CPCP, 2003 - present - which specializes in the epidemiology of cancer and lifestyle intervention trials for cancer, with a focus on cancer disparities). The two projects that comprise the proposed grant address two Specific Aims that are represented by the human study and laboratory animal experiment: i.e. ,1: To establish the metabolic protective effects of an anti-inflammatory diet in obese, high-risk African-American (AA) and European-American (EA) adults and children in reducing inflammation as indicated by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), IGF-1, Tumor Necrosis Factor alpha (TNFα), Interleukin 6 (IL-6), and C-Reactive Protein (CRP), and a creating more favorable microbiome signature; 2: To establish gut microbes as mediators between anti-inflammatory dietary input and reversal of metabolic dysfunction and associated CRC risk. This complements the human study by carrying out pre-clinical murine model studies with similar inputs (diet), intermediate endpoints (inflammation, microbiome), and outcomes (CRC-related). We hypothesize that an anti-inflammatory dietary intervention will reduce metabolic dysfunction and metainflammation through regulatory effects on gut microbiota.\n\nResults from this work will address the role of metabolic dysregulation in relation to factors that are known to be important in carcinogenesis, that therefore could have profound effects on EOCRC, have implications for other obesity-related cancers, and have great promise for moving the field forward by addressing mechanisms that drive large health-related disparities that consistently disfavor African Americans.",[19,20,21],"Colorectal Cancer","Inflammation","Nutrition Related Cancer",[23,24,25,26],"Body Composition","Cancer","Digestive System","Microbiome","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},180,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","IMAGINE HEALTHY","An anti-inflammatory nutrition program including cooking classes, physical activity, and stress reduction.",[40],"Intervention",[42,46],{"measure":43,"description":44,"timeFrame":45},"Blood","Tumor Necrosis Factor alpha (TNFα), Interleukin 6 (IL-6), and C-Reactive Protein (CRP)","Baseline, 3-month, 6-month",{"measure":47,"description":48,"timeFrame":45},"Stool","Determine race-specific microbiome signatures associated with anti-inflammatory dietary input and reversal of metabolic dysfunction",[],"ALL","9 Years","55 Years",{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Individuals eligible to participate in this study will be apparently disease- free, obese (BMI ≥ 30kg\u002Fm2) AAs or EAs who have self-identified a partner who is at least 9 years old, with whom they live and who also is at least overweight. Each index patient will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have agreed to undergo colonoscopy screening and found to have ≥1 polyp(s) that place them at elevated risk for future adenomas and CRC; 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg\u002Fm2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use (≤3 months). Their dyad partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, anthropometric measurements, and self-reported dietary and other assessments; 5) Have no recent antibiotic use (≤3 months).",[58,59],"CHILD","ADULT",[61],{"facility":13,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":75},"Columbia","South Carolina","29208","United States",[67,72],{"name":68,"role":69,"phone":70,"email":71},"James R Hebert, ScD","CONTACT","803-576-5613","jhebert@sc.edu",{"name":73,"role":69,"phone":70,"email":74},"Gauri Sathe","satheg@mailbox.sc.edu",{"lat":76,"lon":77},34.00071,-81.03481,[],[],[],[],{"nct_id":4,"conditions":83,"biomarkers":85},[84],"Colorectal Carcinoma",[],{"nct_id":4,"found":15,"summary":87,"prompt_version":96},{"design":88,"status":89,"heading":6,"summary":90,"follow_up":91,"word_count":92,"commitments":93,"compensation":94,"drugs_mentioned":95},"This is a 6-month randomized controlled trial. It aims to enroll 180 participants.","completed","This 6-month study is looking for adults (ages 9-55) who are obese and have had at least one polyp found during a colonoscopy screening. You would also need to identify a partner (at least 9 years old and overweight) who lives with you. The study is testing an intervention called IMAGINE HEALTHY, which is an anti-inflammatory nutrition program. This program includes cooking classes, physical activity, and stress reduction. Researchers want to see if this program can help reduce chronic inflammation and reverse metabolic problems in people at risk for colorectal cancer. The study is currently unclear on its recruitment status and plans to enroll 180 participants.","Your blood and stool will be measured at 3 months and 6 months after starting the study.",106,"You would participate in an anti-inflammatory nutrition program including cooking classes, physical activity, and stress reduction. Blood and stool samples will be collected at the beginning, 3 months, and 6 months.","Not stated in the trial record.",[37],"v2"]