Navy Bean Diet for Obesity and Colorectal Cancer Risk

Recruiting in Houston (>99 mi)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Cytokines, Immunosuppressants, Chemopreventives, others

Disqualifiers: Antibiotic use, Smoking, Heavy drinking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

71 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies if eating canned beans regularly can improve gut health and reduce cancer risk in colorectal cancer survivors or those with precancerous polyps and a BMI of 25 or higher. Beans help by boosting healthy bacteria in the digestive system.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, like cytokines, immunosuppressive agents, chemopreventive drugs, bile acid sequestrants, cholesterol absorption inhibitors, anti flatulence medications, probiotics, and fiber supplements, to participate in this study.

What data supports the effectiveness of the treatment Navy Beans (Canned) for obesity and colorectal cancer risk?

Research suggests that a diet high in vegetable fibers, like those found in navy beans, may help reduce the risk of colorectal cancer. Additionally, high fiber intake is associated with lower cancer progression and death rates in people with colorectal cancer. ^{1 2 3 4 5}

Is the Navy Bean Diet safe for humans?

Studies show that consuming navy beans is generally safe for humans and may even offer health benefits, such as reducing waist circumference and providing cancer-protective effects. ^{6 7 8 9 10}

How does the navy bean diet treatment differ from other treatments for obesity and colorectal cancer risk?

The navy bean diet is unique because it uses canned navy beans, a natural food source, to reduce obesity-related risk factors and potentially lower colorectal cancer risk by improving gut health. Unlike traditional treatments, which may involve medications or invasive procedures, this approach focuses on dietary changes that are easy to incorporate into daily life. ^{6 7 8 9 11}

Research Team

Carrie Daniel-MacDougall, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking adults over 30 in the Houston area who are overweight or obese, with a history of colorectal cancer or precancerous polyps and normal bowel habits post-treatment. Participants must be willing to follow dietary instructions involving beans, provide stool samples, undergo blood draws, and complete web-based dietary assessments.

Inclusion Criteria

Ability to complete web-based dietary assessments twice per week

I am willing to give stool samples and have my blood drawn.

Willingness to consume/avoid beans as instructed during the 16 weeks from randomization

Exclusion Criteria

Current smoker

I have taken antibiotics in the last month and cannot delay joining the trial.

I am not on any drugs that might interfere with the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Phase 1

Participants follow a diet for 8 weeks; intervention group adds beans to their diet, control group follows normal diet

8 weeks

5 visits (in-person), stool samples collected

Treatment Phase 2

Participants switch groups and follow the opposite diet for another 8 weeks

8 weeks

5 visits (in-person), stool samples collected

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-Term Follow-Up

Participants are contacted up to 2 times each year for up to 5 years to assess long-term outcomes

Up to 5 years

Contact by phone, email, or mail

Treatment Details

Interventions

• Navy Beans (Canned)

Trial Overview The BE GONE Trial aims to determine if consuming canned navy beans can enhance gut microbiome health and mitigate obesity's adverse effects on cancer risk. All participants will either continue their regular diet or add navy beans to their meals for 16 weeks.

Participant Groups

Group I: Regular Diet + Beans, Then Regular Diet - Beans Experimental Treatment 2 Interventions

Group II: Regular Diet - Beans, Then Regular Diet + Beans Active Control 2 Interventions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

High dietary fat intake (40-45% of calories) is linked to an increased risk of large bowel cancer, particularly in the descending and sigmoid colon, while a high intake of cereal fibers is associated with a lower risk, as seen in Finland.

Recommendations suggest reducing fat intake to 20-25% of calories and increasing fiber intake to about 30 grams daily from whole grains and cruciferous vegetables, as these dietary changes have no obvious adverse effects and can help in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large bowel cancer: prospects for control. Wynder, EL.[2017]

In a 28-day dietary intervention trial with 16 adults (7 non-cancer and 9 CRC survivors), the inclusion of 35 grams of cooked navy bean powder in meals was feasible and led to significant increases in fiber intake, particularly for CRC survivors.

Non-cancer participants showed a significant decrease in total caloric intake after four weeks, suggesting that navy bean powder can be a beneficial addition to diets for both cancer prevention and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. Borresen, EC., Gundlach, KA., Wdowik, M., et al.[2021]

In a study of 14 overweight and obese adults, consuming 5 cups of canned navy beans per week for 4 weeks significantly reduced waist circumference, with females losing an average of 2.5 cm and males 2.1 cm (P < 0.001).

The consumption of navy beans also positively affected metabolic risk factors, showing a notable decrease in pulse rate, total cholesterol, and LDL cholesterol in males, while females experienced an increase in pulse rate but stable cholesterol levels, indicating a sex-dependent response to bean consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canned Navy Bean Consumption Reduces Metabolic Risk Factors Associated with Obesity. Luhovyy, BL., Mollard, RC., Panahi, S., et al.[2017]

The BE GONE trial is investigating whether increasing the intake of pre-cooked, canned dry beans can improve metabolic health and reduce cancer risk in overweight/obese patients with a history of colorectal polyps or cancer, using a randomized crossover design with 16 weeks of monitoring.

This study aims to understand how dietary changes, specifically the addition of dry beans, affect the gut microbiome and related health markers, potentially offering a scalable prevention strategy against colorectal cancer and other obesity-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. Zhang, X., Browman, G., Siu, W., et al.[2023]

In a study involving 160 male obese mice, diets containing cooked navy beans significantly reduced the incidence of colon cancer lesions compared to a control diet, with reductions of up to 91% for adenomas and adenocarcinomas.

Both the soluble and insoluble fractions of cooked navy beans contributed to their cancer-preventive effects, indicating that consuming whole beans may provide multiple protective benefits against colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cooked navy beans and their fractions attenuate colon carcinogenesis in azoxymethane-induced ob/ob mice. Bobe, G., Barrett, KG., Mentor-Marcel, RA., et al.[2021]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Obesity and colorectal cancer. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Obesity and Colorectal Cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Dietary fat in relation to all-cause mortality and cancer progression and death among people with metastatic colorectal cancer: Data from CALGB 80405 (Alliance)/SWOG 80405. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of cereal fibre source and processing on rectal epithelial cell proliferation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Large bowel cancer: prospects for control. [2017]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Feasibility of Increased Navy Bean Powder Consumption for Primary and Secondary Colorectal Cancer Prevention. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Canned Navy Bean Consumption Reduces Metabolic Risk Factors Associated with Obesity. [2017]

8. England pubmed.ncbi.nlm.nih.gov

The BE GONE trial study protocol: a randomized crossover dietary intervention of dry beans targeting the gut microbiome of overweight and obese patients with a history of colorectal polyps or cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary cooked navy beans and their fractions attenuate colon carcinogenesis in azoxymethane-induced ob/ob mice. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Plasma and Urine Metabolite Profiles Impacted by Increased Dietary Navy Bean Intake in Colorectal Cancer Survivors: A Randomized-Controlled Trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Consumption of black beans and navy beans (Phaseolus vulgaris) reduced azoxymethane-induced colon cancer in rats. [2013]