Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

NCT04780477 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00000563R01CA245063
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether a high-fiber diet based on legumes, such as dry beans, can lead to sustained reductions in obesity and colon cancer risk in persons at highest risk, namely overweight or obese, post-polypectomy patients.

Conditions

Colon Cancer; Obesity

Keywords

Fiber-rich Foods; Legumes; Weight loss; Intestinal health; Cancer prevention

Outcome Measures

Primary Outcomes (2)

• Change in Body Weight

  Body weight is measured (in pounds) on a regularly calibrated digital scale while wearing light clothing without shoes.

  Baseline, Month 6 (end of intense intervention)

• Change in Ki-67+ Level

  Mucosal biopsies are obtained to measure the colonic mucosal proliferative biomarker Ki-67+.

  Baseline, Month 6 (end of intense intervention)

Secondary Outcomes (8)

• Change in Body Weight During Maintenance Period

  Month 6, Month 12

• Change in Ki-67+ Level During Maintenance Period

  Month 6, Month 12

• Change in Gut Transit Time

  Baseline, Month 6 (end of intense intervention)

• Change in Fasting Plasma Insulin Level

  Baseline, Month 6, Month 12

• Change in Fasting Plasma Glucose Level

  Baseline, Month 6, Month 12

Study Arms (2)

High Fiber Diet Featuring Legumes (HLD)

EXPERIMENTAL

Participants randomized to the high fiber diet featuring legumes (HLD) will add approximately 30 grams of dietary fiber per day from legume dishes, ensuring a total intake of approximately 50 grams of dietary fiber per day.

Dietary Supplement: High Fiber Diet Featuring Legumes (HLD)

Healthy American Diet Control Arm

ACTIVE COMPARATOR

Participants randomized to the healthy American diet control arm will receive pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat.

Dietary Supplement: Healthy American Diet

Interventions

High Fiber Diet Featuring Legumes (HLD) DIETARY_SUPPLEMENT

The high fiber diet featuring legumes (HLD) provides pre-portioned entrées for two meals per day in months 1-3, and one meal per day in months 4-6. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. The HLD will contain approximately 250 grams (g) of legumes per day (\~1 ½ cups cooked legumes) in months 1-3 provided in two pre-portioned single serving entrées (i.e. \~125g in each serving). A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

High Fiber Diet Featuring Legumes (HLD)

Healthy American Diet DIETARY_SUPPLEMENT

The healthy American diet provides pre-portioned meal replacement entrées with legumes replaced by lean chicken or meat. Participants continue on the diet in months 7-12 but assume responsibility for food preparation. A study nutritionist provides in-person and written guidance for including side dishes that are nutritionally balanced with energy intake to lose 1-2 pounds of weight per week.

Healthy American Diet Control Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• free-living adults 40 to 75 years old
• BMI 25-40 kg/m\^2
• able to provide documentation confirming a colonoscopy within 3 years that found ≥1 adenoma \>0.5 cm or a sessile serrated polyp (any)
• English speaking
• ambulatory, able to pick up food, participate in clinical exams and laboratory tests
• able to provide informed consent

You may not qualify if:

• serious and/or unstable medical condition as deemed by study physician
• history of colorectal cancer, 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 months
• regular or recent use of prescription medication that may alter inflammation markers or gut function as deemed by study physician
• pregnant women, breast feeding women, or women planning pregnancy within the year of active study participation

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rollins School of Public Health, Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• Hartman TJ, Christie J, Wilson A, Ziegler TR, Methe B, Flanders WD, Rolls BJ, Loye Eberhart B, Li JV, Huneault H, Cousineau B, Perez MR, O'Keefe SJD. Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerous adenomatous polyps. BMJ Open. 2024 Feb 5;14(2):e081379. doi: 10.1136/bmjopen-2023-081379.

  PMID: 38316601 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Terry Hartman, PhD, MPH, RD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 3, 2021
• Study Start: June 29, 2021
• Primary Completion: May 29, 2025
• Study Completion: December 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be made available for sharing beginning 9 months and ending 36 months following publication of findings for this study.
• Access Criteria: Proposals to share individual participant data 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.

Locations

US (1)