Navy Bean Diet for Obesity and Colorectal Cancer Risk

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if eating canned navy beans can boost healthy gut bacteria and reduce obesity's impact on colorectal cancer risk. Participants will follow a specific diet plan with and without these beans to compare effects. Ideal candidates include those who have had colorectal cancer or precancerous polyps and are currently overweight (with a body mass index of 25 or higher). Participants must be comfortable traveling to MD Anderson and willing to follow dietary instructions, including eating beans during the trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and cancer prevention.

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 prior data suggests that this diet is safe for humans?

Research has shown that adding navy beans to the diet is safe and easy to manage. One study found that eating navy beans daily safely improved gut health by altering the types of bacteria in the digestive system. Another study on mice demonstrated that diets including navy beans reduced colon cancer growths, suggesting potential benefits without harmful effects. Evidence also indicates that navy beans can provide important nutrients to individuals at risk for colorectal cancer without causing major side effects. These findings suggest that navy beans are a safe addition to the diet for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for obesity and colorectal cancer risk, which often involve medications, surgery, or intensive lifestyle changes, the use of navy beans is unique because it taps into the power of natural dietary modification. Navy beans are rich in fiber, which may help in weight management and potentially lower cancer risk by improving gut health. Researchers are excited because this approach is simple, accessible, and could offer a natural, less invasive alternative to current options. By incorporating navy beans into a regular diet, there is potential for a novel, food-based intervention that could complement existing treatments and provide additional health benefits.

What evidence suggests that eating navy beans might be an effective treatment for obesity and colorectal cancer risk?

Research has shown that eating navy beans might help lower the risk of colon cancer. In a study with mice, a diet including cooked navy beans greatly reduced the number of cancerous spots in the colon. Other research suggests that navy beans can improve gut health, which is important for colorectal cancer survivors. This trial will evaluate two dietary approaches involving navy beans. One group will follow a regular diet with beans, then switch to a regular diet without beans. The other group will start with a regular diet without beans, then add beans. For those who have had colorectal cancer, adding navy beans to their diet can help increase healthy gut bacteria. Overall, these findings suggest that navy beans could benefit gut health and might reduce cancer risk, especially for those with a history of colorectal issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Carrie Daniel-MacDougall, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2423381/

Dietary Cooked Navy Beans and Their Fractions Attenuate ... The 60% ethanol-soluble fraction of dietary cooked navy beans significantly decreased the incidence of neoplastic colon lesions (adenoma and adenocarcinoma) to ...

2. withpower.com withpower.com/trial/phase-colorectal-neoplasms-6-2016-78dca

Navy Bean Diet for Obesity and Colorectal Cancer Risk 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 ...

3. news-medical.net news-medical.net/news/20231130/Navy-beans-may-improve-gut-health-and-metabolism-in-colorectal-cancer-survivors.aspx

Navy beans may improve gut health and metabolism in ... Incorporating navy beans into the diet of colorectal cancer (CRC) survivors has the potential to positively impact both gut and host health.

4. medicalnewstoday.com medicalnewstoday.com/articles/eating-more-navy-haricot-beans-may-help-colorectal-cancer-prevention-treatment

Colorectal cancer: Eating more navy beans may improve ... Adding navy beans, also known as haricot beans, to the diet of colorectal cancer survivors helps improve their gut microbiome.

5. mdpi.com mdpi.com/2072-6643/11/1/28

Navy Beans Impact the Stool Metabolome and Metabolic ... This 4-week, randomized-controlled trial with overweight and obese CRC survivors involved consumption of 1 meal and 1 snack daily. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5145262/

A randomized-controlled trial to increase navy bean or rice ... Consumption of navy beans (NB) and rice bran (RB) have been shown to inhibit colon carcinogenesis. Given the overall poor diet quality in colorectal cancer ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6356708/

Navy Beans Impact the Stool Metabolome and Metabolic ... The stool relative abundance of ophthalmate increased 5.25-fold for navy bean consumers that can indicate glutathione regulation, and involving ...

8. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(23)00439-5/fulltext

insights from the BE GONE trial - eBioMedicine Adding one cup of navy beans to the diet on all or most days of the week was a safe, scalable dietary strategy to modulate the gut microbiome of ...

9. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article-abstract/14/4/497/666110

Plasma and Urine Metabolite Profiles Impacted by Increased ... This clinical study suggests that increased consumption of navy beans would deliver bioactive metabolites to individuals at high risk for colorectal cancer ...