Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06117241 |
Other study ID # |
Pro00120270 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 17, 2023 |
Est. completion date |
July 2027 |
Study information
Verified date |
October 2023 |
Source |
University of South Carolina |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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/m2; 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.
Description:
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., <50 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.
Results 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.