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Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

Primary Purpose

Colon Cancer, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: High Fiber Diet (HFD)
Healthy American Diet
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colon Cancer focused on measuring Fiber-rich Foods, Legumes, Weight loss, Intestinal health, Cancer prevention

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • free-living adults 40-75 yrs. old
  • BMI 25-40 kg/m2
  • colonoscopy within 3 years that found ≥1 adenoma >0.5 cm
  • English speaking,
  • ambulatory, able to pick up food, participate in clinical exams and laboratory tests - able to provide informed consent

Exclusion Criteria:

  • serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes,)
  • history of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
  • smoked regularly in the past year
  • dietary restrictions substantially limiting compliance (e.g., must be willing to be randomized to either diet)
  • planning on substantially changing usual exercise behavior in the next 6 mos
  • regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (e.g., non-steroidal anti-inflammatory drugs, antibiotics, insulin, steroids)
  • pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation

Sites / Locations

  • Rollins School of Public Health, Emory UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Fiber Diet (HFD)

Healthy American Diet

Arm Description

High Fiber Diet (HFD) will add approximately 25-30 grams of dietary fiber/d from legume dishes.

Healthy American Diet pre-portioned meal replacement entrées with legumes replaced by lean chicken/meat.

Outcomes

Primary Outcome Measures

Body weight measured in pounds
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Ki-67+ level
Colonic mucosal proliferative marker Ki-67+ will be measured

Secondary Outcome Measures

Body weight measured in pounds
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Ki-67+ level
Colonic mucosal proliferative marker Ki-67+ will be measured
Gut transit time
Gut transit time will be assessed using an indigestible single-use SmartPill capsule, a receiver, and display software.
Fasting plasma insulin level
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Fasting plasma insulin level
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Fasting plasma glucose level
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Fasting plasma glucose level
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Serum C-reactive protein
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
Serum C-reactive protein
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
CD3+ intraepithelial lymphocytes count
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
CD3+ intraepithelial lymphocytes count
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
CD68+ lamina propia macrophages count
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured
CD68+ lamina propia macrophages count
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured

Full Information

First Posted
March 2, 2021
Last Updated
March 15, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04780477
Brief Title
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Official Title
Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
June 15, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.
Detailed Description
The goal of the research is to conduct a clinical trial featuring study-provided pre-portioned entrées (2 entrées per day months 1-3, 1 entrée per day months 4-6) and strategic nutritional instruction to guide participants to integrate legumes into a healthy high-fiber diet pattern. The research will target a population at high risk for colorectal cancer, overweight and obese participants with a history of a colon polyp in the past 3 years, to test whether a high-legume, high-fiber diet will simultaneously increase weight loss and suppress intestinal biomarkers of cancer risk compared to a control diet (healthy American). In addition, it will explore potential mechanisms through which the high-legume intervention diet facilitates weight loss and intestinal health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Obesity
Keywords
Fiber-rich Foods, Legumes, Weight loss, Intestinal health, Cancer prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Fiber Diet (HFD)
Arm Type
Experimental
Arm Description
High Fiber Diet (HFD) will add approximately 25-30 grams of dietary fiber/d from legume dishes.
Arm Title
Healthy American Diet
Arm Type
Active Comparator
Arm Description
Healthy American Diet pre-portioned meal replacement entrées with legumes replaced by lean chicken/meat.
Intervention Type
Dietary Supplement
Intervention Name(s)
Experimental: High Fiber Diet (HFD)
Intervention Description
Experimental: High Fiber Diet (HFD) pre-portioned entrées for two meals/d in mos. 1-3, and one meal/d in mos. 4-6. Participants continue on their respective diets in mos. 7-12 but assume responsibility for food preparation. The HLD will contain approximately 250g of legumes per day (~1 ½ cups cooked) in months 1-3 provided in two pre-portioned single serving entrées (i.e. ~125g each). A study nutritionist will provide in-person and written guidance for including sides that are nutritionally balanced with energy intake to lose 1-2 lbs. /wk.
Intervention Type
Dietary Supplement
Intervention Name(s)
Healthy American Diet
Intervention Description
Healthy American Diet pre-portioned meal replacement entrées with legumes replaced by lean chicken/meat. A study nutritionist will provide in-person and written guidance for including sides that are nutritionally balanced with energy intake to lose 1-2 lbs. /wk.
Primary Outcome Measure Information:
Title
Body weight measured in pounds
Description
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Time Frame
6 months
Title
Ki-67+ level
Description
Colonic mucosal proliferative marker Ki-67+ will be measured
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Body weight measured in pounds
Description
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Time Frame
12 months
Title
Ki-67+ level
Description
Colonic mucosal proliferative marker Ki-67+ will be measured
Time Frame
12 months
Title
Gut transit time
Description
Gut transit time will be assessed using an indigestible single-use SmartPill capsule, a receiver, and display software.
Time Frame
6 months
Title
Fasting plasma insulin level
Description
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Time Frame
6 months
Title
Fasting plasma insulin level
Description
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Time Frame
12 months
Title
Fasting plasma glucose level
Description
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Time Frame
6 months
Title
Fasting plasma glucose level
Description
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Time Frame
12 months
Title
Serum C-reactive protein
Description
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
Time Frame
6 months
Title
Serum C-reactive protein
Description
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
Time Frame
12 months
Title
CD3+ intraepithelial lymphocytes count
Description
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
Time Frame
6 months
Title
CD3+ intraepithelial lymphocytes count
Description
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
Time Frame
12 months
Title
CD68+ lamina propia macrophages count
Description
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured
Time Frame
6 months
Title
CD68+ lamina propia macrophages count
Description
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: free-living adults 40-75 yrs. old BMI 25-40 kg/m2 colonoscopy within 3 years that found ≥1 adenoma >0.5 cm English speaking, ambulatory, able to pick up food, participate in clinical exams and laboratory tests - able to provide informed consent Exclusion Criteria: serious medical condition (e.g., cancer, heart disease, kidney disease, diabetes,) history of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease smoked regularly in the past year dietary restrictions substantially limiting compliance (e.g., must be willing to be randomized to either diet) planning on substantially changing usual exercise behavior in the next 6 mos regular use of medication that may alter inflammation markers, insulin, glucose, or gut function (e.g., non-steroidal anti-inflammatory drugs, antibiotics, insulin, steroids) pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terry Hartman, PhD, MPH, RD
Phone
404-727-9134
Email
tjhartm@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Hartman, PhD, MPH, RD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rollins School of Public Health, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Hartman, PHD, MPH
Email
fiber.diet.study@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Limited de-identified participant phenotypic data will be shared but limited to health/biomedical purposes including age, obesity status, presence of colon polyps and history of diabetes. The data will be coded. Only the coded data set and not the master list will be shared.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Proposals should be directed to tjhartm@emory.edu. To gain access requestors will need to sign a data access agreement. To meet NIH data sharing requirements selected data will be deposited in appropriate research data repositories (e.g., NIH Common Fund Metabolomics Workbench). For genomic data, all data generated by this project will be made publicly available through adequate public genomic data warehouses as appropriate to the data type (NCBI Short Read Archives, Gene expression omnibus, etc.). Sequence data will be screened for the presence of sequences from human and these will be removed from public submissions unless directed otherwise by the NIH. Our algorithms will be made available through publications and as standalone programs when this is feasible. All new genomic and microbiome datasets will be deposited in public databases.

Learn more about this trial

Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

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