Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753359
Status:
RECRUITING
Last Update Posted:
2023-04-13
First Post:
2021-01-29
Brief Title:
Mediterranean Diet and Weight Loss Targeting the Bile AcidGut Microbiome Axis to Reduce Colorectal Cancer
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Mediterranean Diet and Weight Loss Targeting the Bile AcidGut Microbiome Axis to Reduce Colorectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bridge CRC
Brief Summary:
A Mediterranean Diet MedDiet a largely plant-based dietary pattern is relevant to CRC prevention and microbial production of anti-cancer metabolites in observational studies A MedDiet can shift BA metabolism as shown in primates and when combined with calorie restriction shows superior adherence and weight control in humans given its palatability To date no studies have tested in an RCT the effects of a MedDiet alone MedA WL through lifestyle intervention WL-A or a calorie-restricted MedDiet for WL WL-Med on the BA-gut microbiome axis and its relevance to CRC prevention among AAs A multidisciplinary team combining expertise in psychology nutrition microbiology molecular cell biology computational biology medicine and biostatistics proposes to conduct a four-arm RCT in which 232 obese AAs 45-75 years old complete one of the following 6-month interventions Med-A weight stable WL-A calorie restriction with no diet pattern change WLMed or Control The investigators will use samples and data collected at baseline mid-study month-3 and post-intervention to compare the effects of the interventions on 1 Concentration and composition of circulating and fecal BAs 2 Gut microbiota and metabolic function and 3 Gene expression profiles of exfoliated intestinal epithelial cells
Detailed Description:
Colorectal cancer CRC is associated with multiple risk factors including obesity low fiber diets and diets high in animal protein and saturated fat SFat African Americans AAs have a higher prevalence of these risk factors and they have the highest incidence of CRC and related mortality These multiple risk factors are also linked to higher circulating and fecal bile acids BA and a shift in BA amino acid conjugation from glycine to taurine These BA-related changes can alter the composition structure and metabolic activity of the gut microbiota fostering conditions for gut bacteria to expand and metabolize taurine-conjugated BAs to genotoxic hydrogen sulfide H2S and the tumor promoter deoxycholic acid DCA a colonic milieu conducive to the formation of CRC The investigators have shown that the abundance of H2S-producing bacteria is significantly higher in the colon of AAs compared to non-Hispanic whites NHWs and is a defining feature among AA CRC cases implicating these bacteria as contributors to CRC development in a race-dependent manner Moreover the microbial difference is associated with higher intake of SFat and animal protein in AAs providing a pivotal intervention target The investigators hypothesize that targeting the BA-gut microbiome axis to suppress abundance growth and metabolic activity of H2S and DCA producing bacteria through diet and weight loss WL may reduce CRC risk especially among AAs A Mediterranean Diet MedDiet a largely plant-based dietary pattern is relevant to CRC prevention and microbial production of anti-cancer metabolites in observational studies A MedDiet can shift BA metabolism as shown in primates and when combined with calorie restriction shows superior adherence and weight control in humans given its palatability To date no studies have tested in an RCT the effects of a MedDiet alone MedA WL through lifestyle intervention WL-A or a calorie-restricted MedDiet for WL WL-Med on the BA-gut microbiome axis and its relevance to CRC prevention among AAs Our multidisciplinary team combining expertise in psychology nutrition microbiology molecular cell biology computational biology medicine and biostatistics propose to conduct a four-arm RCT in which 232 obese AAs 45-75 years old complete one of the following 6-month interventions Med-A weight stable WL-A calorie restriction with no diet pattern change WLMed or Control The investigators will use samples and data collected at baseline mid-study month-3 and post-intervention to compare the effects of the interventions on 1 Concentration and composition of circulating and fecal BAs 2 Gut microbiota and metabolic function and 3 Gene expression profiles of exfoliated intestinal epithelial cells The investigators approach is strong given the multidisciplinary team use of evidence-based lifestyle interventions and sophisticated -omics analyses to examine crosstalk between dietWL gut microbiome and host intestinal physiology If successful this study could have profound public health impact on CRC risk among AAs and other high-risk populations that would translate into timely dissemination opportunities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA250390-01A1 | NIH | None | httpsreporternihgovquickSearch1R01CA250390-01A1 |