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Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

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ClinicalTrials.gov Identifier: NCT04780477
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Terry Hartman, Emory University

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Obesity Dietary Supplement: Experimental: High Fiber Diet (HFD) Dietary Supplement: Healthy American Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: High Fiber Diet (HFD)
High Fiber Diet (HFD) will add approximately 25-30 grams of dietary fiber/d from legume dishes.
Dietary Supplement: Experimental: High Fiber Diet (HFD)
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.

Active Comparator: Healthy American Diet
Healthy American Diet pre-portioned meal replacement entrées with legumes replaced by lean chicken/meat.
Dietary Supplement: Healthy American Diet
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 Measures :
  1. Body weight measured in pounds [ Time Frame: 6 months ]
    Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale

  2. Ki-67+ level [ Time Frame: 6 months ]
    Colonic mucosal proliferative marker Ki-67+ will be measured


Secondary Outcome Measures :
  1. Body weight measured in pounds [ Time Frame: 12 months ]
    Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale

  2. Ki-67+ level [ Time Frame: 12 months ]
    Colonic mucosal proliferative marker Ki-67+ will be measured

  3. Gut transit time [ Time Frame: 6 months ]
    Gut transit time will be assessed using an indigestible single-use SmartPill capsule, a receiver, and display software.

  4. Fasting plasma insulin level [ Time Frame: 6 months ]
    Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test

  5. Fasting plasma insulin level [ Time Frame: 12 months ]
    Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test

  6. Fasting plasma glucose level [ Time Frame: 6 months ]
    Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test

  7. Fasting plasma glucose level [ Time Frame: 12 months ]
    Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test

  8. Serum C-reactive protein [ Time Frame: 6 months ]
    Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test

  9. Serum C-reactive protein [ Time Frame: 12 months ]
    Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test

  10. CD3+ intraepithelial lymphocytes count [ Time Frame: 6 months ]
    Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured

  11. CD3+ intraepithelial lymphocytes count [ Time Frame: 12 months ]
    Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured

  12. CD68+ lamina propia macrophages count [ Time Frame: 6 months ]
    Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured

  13. CD68+ lamina propia macrophages count [ Time Frame: 12 months ]
    Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780477


Contacts
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Contact: Terry Hartman, PhD, MPH, RD 404-727-8713 tjhartm@emory.edu

Locations
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United States, Georgia
Rollins School of Public Health, Emory University
Atlanta, Georgia, United States, 30322
Contact: Terry Hartman, PHD, MPH    404-727-8713    terryl.johnson.hartman@emory.edu   
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Terry Hartman, PhD, MPH, RD Emory University
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Responsible Party: Terry Hartman, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04780477    
Other Study ID Numbers: STUDY00000563
R01CA245063 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Terry Hartman, Emory University:
Fiber-rich Foods
Legumes
Weight loss
Intestinal health
Cancer prevention
Additional relevant MeSH terms:
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Colonic Neoplasms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases