Fiber-rich Foods to Treat Obesity and Prevent Colon Cancer

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04780477

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

42.1

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Obesity	Dietary Supplement: Experimental: High Fiber Diet (HFD) Dietary Supplement: Healthy American Diet	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Jun 29, 2021

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Body weight measured in pounds [6 months]
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Ki-67+ level [6 months]
Colonic mucosal proliferative marker Ki-67+ will be measured

Secondary Outcome Measures

Body weight measured in pounds [12 months]
Participants will have their body weight measured in light clothing without shoes on a regularly calibrated digital scale
Ki-67+ level [12 months]
Colonic mucosal proliferative marker Ki-67+ will be measured
Gut transit time [6 months]
Gut transit time will be assessed using an indigestible single-use SmartPill capsule, a receiver, and display software.
Fasting plasma insulin level [6 months]
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Fasting plasma insulin level [12 months]
Biomarker of insulin resistance - fasting plasma insulin - will be measured by blood test
Fasting plasma glucose level [6 months]
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Fasting plasma glucose level [12 months]
Biomarker of insulin resistance - fasting plasma glucose - will be measured by blood test
Serum C-reactive protein [6 months]
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
Serum C-reactive protein [12 months]
Systemic inflammation indicator - serum C-reactive protein - will be measured by blood test
CD3+ intraepithelial lymphocytes count [6 months]
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
CD3+ intraepithelial lymphocytes count [12 months]
Colonic mucosal inflammatory biomarker - CD3+ intraepithelial lymphocytes - will be measured
CD68+ lamina propia macrophages count [6 months]
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured
CD68+ lamina propia macrophages count [12 months]
Colonic mucosal inflammatory biomarker - CD68+ lamina propia macrophages - will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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