Plant-Based Diet for Colorectal Cancer

(DIET Trial)

Overseen By Teresa Barry

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Chicago

Must not be taking: Antibiotics, Prebiotics, Probiotics, others

Disqualifiers: Ostomy, Separate malignancy, Pregnancy, others

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

Compensation: Varies

Number of Visits: 30

80 Participants Needed

Trial Summary

What is the purpose of this trial?

A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that you should not have taken antibiotics or prebiotics/probiotics within 60 days before starting the diet.

What data supports the effectiveness of the treatment Plant-Based Meals, High-Fiber Diet, Low-Fat Diet, Standardized Preoperative Diet for colorectal cancer?

Research suggests that a high intake of cereal fiber and calcium is associated with a reduced risk of colorectal cancer, and plant-based diets are generally recommended for health. However, extreme fat restriction might increase the recurrence of colorectal tumors, indicating that balance is important in dietary interventions. ^{1 2 3 4 5}

Is a plant-based diet safe for humans?

Plant-based diets, including those high in fiber and low in fat, are generally considered safe for humans and have been studied for their potential health benefits, including reducing the risk of colorectal cancer. ^{2 6 7 8 9}

How does the plant-based diet treatment for colorectal cancer differ from other treatments?

The plant-based diet treatment for colorectal cancer is unique because it focuses on a high-fiber, low-fat diet, which may help reduce cancer risk by promoting healthier gut function and reducing inflammation, unlike traditional treatments that often involve medication or surgery. ^{2 6 7 10 11}

Research Team

Benjamin Shogan

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for individuals diagnosed with colorectal cancer who are scheduled for tumor removal surgery in more than 21 days. Participants will need to follow a special diet and keep a food diary before their operation, give blood samples, and provide stool samples at certain times.

Inclusion Criteria

I may have had chemotherapy or radiation before surgery.

I am 18 years old or older.

Patients with Hepatic arterial infusion (HAI) pumps are considered eligible

Exclusion Criteria

Prebiotic exposure within 90 days before diet initiation

I have not taken antibiotics in the last 90 days.

I have or have had an ileostomy or colostomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention

Participants receive 21 days of standardized high-fiber/low-fat meals and complete a food diary

3 weeks

Baseline visit for blood sample collection, stool samples collected at specific timepoints

Surgery

Tumor resection surgery is performed, and tissue is isolated for organoid cultures

1 day

Surgery day visit for blood and stool sample collection

Follow-up

Participants are monitored for safety and effectiveness after surgery, with stool samples collected 30 days post-surgery

6 months

Post-op visits including 30 days and 6 months post-surgery

Long-term Follow-up

Participants are followed per standard of care for up to 5 years or until disease recurrence

Up to 5 years

Treatment Details

Interventions

• Plant-Based Meals

Trial Overview The study tests if eating standardized plant-based low fat/high-fiber meals for 21 days before surgery can prevent the return or spread of colorectal cancer after the tumor is removed. It also involves monitoring through blood, stool samples, and tissue cultures.

Participant Groups

Group I: Dietary Intervention Participants Experimental Treatment 1 Intervention

Subjects will be provided 21 days of standardized plant-based low fat/ high-fiber meals and complete a food diary up until lunch on the day prior to surgery.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Patients with colorectal cancer consumed more energy from fats, proteins, and carbohydrates compared to matched control subjects, but their diets were significantly lower in cereal fiber, riboflavin, calcium, and phosphorus.

Higher intakes of cereal fiber, calcium, and total fiber were associated with a reduced risk of colorectal cancer, while high alcohol consumption was linked to an increased risk, supporting previous research on diet and cancer incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cereal fiber, calcium, and colorectal cancer. Arbman, G., Axelson, O., Ericsson-Begodzki, AB., et al.[2019]

A healthy plant-based diet (hPDI) is linked to a lower incidence of colorectal cancer (CRC), with a hazard ratio of 0.86, indicating a significant protective effect, especially against KRAS-wildtype CRC.

Conversely, an unhealthy plant-based diet (uPDI), characterized by refined grains and sugars, is associated with a higher incidence of CRC, with a hazard ratio of 1.16, highlighting the importance of diet quality in cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy and unhealthy plant-based diets in relation to the incidence of colorectal cancer overall and by molecular subtypes. Wang, F., Ugai, T., Haruki, K., et al.[2022]

Preoperative malnutrition is a significant risk factor for complications in colorectal cancer patients, and early detection using screening tools like NRS-2002 or MUST is crucial for effective intervention.

The Enhanced Recovery After Surgery (ERAS) concept emphasizes minimizing nutrient intake interruption and includes strategies like high-caloric oral supplementation and 'prehabilitation' to optimize patients' physical and psychological health before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peri- and postoperative nutrition in colorectal cancer patients]. Reischl, S., Wilhelm, DF., Neumann, PA., et al.[2019]

A 6-month dietary intervention focusing on healthy eating significantly reduced weight gain and fat mass gain in colorectal cancer survivors compared to a control group, with 0.7 kg less weight gain and 0.6 kg less fat mass gain observed.

The intervention also led to a lower increase in visceral adipose tissue and a more favorable fat-to-fat-free mass ratio, suggesting that dietary changes can positively impact body composition in CRC patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a one-year personalized intensive dietary intervention on body composition in colorectal cancer patients: Results from a randomized controlled trial. Alavi, DT., Henriksen, HB., Lauritzen, PM., et al.[2023]

In a study involving 373 participants over 4 years, reducing fat intake to 18-22% of energy did not decrease colorectal tumor recurrence; in fact, the lowest recurrence was found in men consuming 23.8-26.4% fat energy ratio.

The findings suggest that extreme fat restriction may actually increase the risk of colorectal tumors, potentially due to a deficiency in linoleic acid, highlighting the importance of balanced dietary fat intake rather than strict reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excessive fat restriction might promote the recurrence of colorectal tumors. Nakamura, T., Ishikawa, H., Takeyama, I., et al.[2022]

A Phase III Dietary Intervention Study is underway to assess whether a low-fat, high-fiber diet rich in fruits and vegetables can reduce the recurrence of large bowel adenomatous polyps, which are precursors to colorectal cancer.

The Chemoprevention Program is conducting four Phase III trials to evaluate the cancer-inhibiting effects of various substances, including beta-carotene and calcium, in individuals with a history of adenomas, highlighting ongoing efforts to find effective preventive therapies for colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colon cancer overview. Greenwald, P.[2019]

Higher fiber intake is associated with a reduced risk of colorectal cancer (CRC), as it promotes the production of butyrate, a compound with anti-cancer properties.

Conversely, a high-fat diet increases CRC risk by enhancing the conversion of bile acids into harmful compounds like deoxycholic acid, suggesting that managing fiber and fat intake could be effective strategies for CRC prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. Ocvirk, S., Wilson, AS., Appolonia, CN., et al.[2023]

This study is a double-blinded, randomized controlled trial involving 60 Alaska Native participants to assess whether dietary fiber supplementation can significantly reduce colorectal cancer risk, particularly in a population with the highest reported incidence of CRC.

Participants will be monitored for changes in inflammatory and proliferative biomarkers related to cancer risk after an 8-week period of fiber supplementation, with additional assessments of gut microbiota and metabolites, ensuring a comprehensive evaluation of the intervention's effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol. Koller, KR., Wilson, A., Normolle, DP., et al.[2021]

In a study of 173,427 participants over a mean follow-up of 19.2 years, men who adhered more closely to healthful plant-based diets showed a significantly reduced risk of colorectal cancer (CRC), with hazard ratios of 0.77 for overall plant-based diet index and 0.80 for healthful plant-based diet index.

No significant association was found between plant-based diet adherence and CRC risk in women, indicating that the protective effects of plant-based diets may be gender-specific and vary by race and tumor location in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plant-based dietary patterns defined by a priori indices and colorectal cancer risk by sex and race/ethnicity: the Multiethnic Cohort Study. Kim, J., Boushey, CJ., Wilkens, LR., et al.[2023]

A study involving 152 proximal and 201 distal colon cancer patients, along with 618 controls, found that vegetable consumption is protective against both types of colon cancer, challenging previous beliefs about dietary fat and fiber's specific roles.

The research highlights that a 'prudent diet' rich in vegetables and low in processed foods may lower the risk of colon cancer, with significant odds ratios indicating that high salad and cruciferous vegetable intake is associated with reduced cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case-control study of proximal and distal colon cancer and diet in Wisconsin. Young, TB., Wolf, DA.[2019]

A study involving 29 colorectal cancer survivors demonstrated that increasing the intake of navy beans and rice bran is feasible and can significantly boost dietary fiber levels without causing major gastrointestinal issues.

The increased consumption of these foods showed potential benefits, including improved serum inflammatory biomarkers, suggesting a positive impact on health that warrants further long-term research in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. Borresen, EC., Brown, DG., Harbison, G., et al.[2018]

References

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

Cereal fiber, calcium, and colorectal cancer. [2019]

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

Healthy and unhealthy plant-based diets in relation to the incidence of colorectal cancer overall and by molecular subtypes. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[Peri- and postoperative nutrition in colorectal cancer patients]. [2019]

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

Effect of a one-year personalized intensive dietary intervention on body composition in colorectal cancer patients: Results from a randomized controlled trial. [2023]

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

Excessive fat restriction might promote the recurrence of colorectal tumors. [2022]

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

Colon cancer overview. [2019]

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

Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. [2023]

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

Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Plant-based dietary patterns defined by a priori indices and colorectal cancer risk by sex and race/ethnicity: the Multiethnic Cohort Study. [2023]

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

Case-control study of proximal and distal colon cancer and diet in Wisconsin. [2019]

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

A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. [2018]