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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of a plant-based diet on individuals with colorectal cancer, particularly those scheduled for surgery. Participants will consume low-fat, high-fiber meals (plant-based meals) for 21 days before surgery to determine if this diet influences cancer outcomes. The study will collect blood, stool, and tissue samples to identify any dietary changes. It suits individuals with confirmed colorectal cancer, who have surgery scheduled more than three weeks away, and can adhere to the dietary plan and sample collections. As a Phase 1, Phase 2 trial, it aims to understand the diet's effects and measure its initial effectiveness, offering participants a chance to contribute to groundbreaking research.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that eating a plant-based diet is linked to a lower risk of colorectal cancer. One study found that this type of diet can reduce the risk by about 14%, suggesting that a plant-based diet might help protect against this cancer.

Plant-based diets are generally safe and healthy. They are high in fiber and low in fat, which benefits overall health. Current research is exploring how a specific plant-based diet works before colorectal cancer surgery. This research is in the early stages and is still being tested for safety and effectiveness.

Overall, plant-based diets are often recommended for their health benefits and are considered safe for most people. However, it's important to consult a doctor before changing a diet, especially during cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer, which often involve surgery, chemotherapy, and radiation, this new approach focuses on the power of nutrition through a plant-based diet. Researchers are excited because this diet is low in fat and high in fiber, which could potentially enhance gut health and reduce inflammation, offering a non-invasive option. Additionally, this dietary intervention might improve patients' overall well-being and possibly slow cancer progression without the harsh side effects commonly seen in traditional therapies.

What evidence suggests that a plant-based diet might be an effective treatment for colorectal cancer?

Research has shown that a low-fat, high-fiber diet might help prevent the recurrence of colorectal cancer and aid recovery after surgery. One study found that this diet could significantly reduce the chances of small growths, called polyps, returning. These polyps can sometimes develop into cancer. Another study indicated that this diet might also enhance the body's healing after surgery. In this trial, participants will receive 21 days of standardized plant-based low-fat/high-fiber meals. These findings suggest that meals rich in plants and fiber could help the body combat colorectal cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Benjamin Shogan

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

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

Ability to understand and willing to sign an informed consent, participate in the dietary intervention, collect stools, donate blood, and complete a pre-nutritional evaluation and compliance/patient satisfaction survey

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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 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]

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]

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]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09390

A Standardized Diet before Colorectal Cancer Surgery ... A standardized low-fat/high-fiber diet before CRC surgery may prevent CRC that has come back after a period of improvement (recurrence) and CRC that has spread ...

2. mdpi.com mdpi.com/1648-9144/60/10/1587

The Impact of Preoperative and Postoperative Nutritional ... (1994) conducted a randomized trial, which showed that a low-fat, high-fiber diet could significantly reduce the recurrence of colorectal polyps. This ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8209565/

Association of Habitual Preoperative Dietary Fiber Intake ... These findings contradict a previous preclinical study showing that a high-fiber and low-fat diet resulted in a decreased risk of anastomotic ...

4. researchgate.net researchgate.net/publication/352472125_Association_of_Habitual_Preoperative_Dietary_Fiber_Intake_With_Complications_After_Colorectal_Cancer_Surgery

Association of Habitual Preoperative Dietary Fiber Intake ... Specifically, a low-fat/high-fiber diet has been shown to improve anastomotic healing in both animal and human visceral surgery. 85, 86 ...

5. mdpi.com mdpi.com/2072-6643/17/14/2386

Acceptability of a Colorectal Cancer-Preventive Diet ... Methods: A one-day sample diet for colorectal cancer prevention, consisting of fiber-rich meals excluding red meat and incorporating whole grains, legumes, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9398226/

Healthy and unhealthy plant‐based diets in relation to ... It is estimated that eliminating the effect of poor‐quality diet in the United States may reduce colorectal cancer (CRC) incidence by approximately 38%.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X25002914

Plant-based diet and colorectal cancer: a systematic review ... The random-effects model demonstrated a significant inverse association between plant-based dietary patterns and CRC risk (hazard ratio [HR], 0.91 [95% CI, 0.85 ...

8. withpower.com withpower.com/trial/plant-based-diet-for-colorectal-cancer-5cf2b

Plant-Based Diet for Colorectal Cancer (DIET Trial) 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 ...

9. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-023-04522-8

Plant-based dietary patterns, genetic predisposition and risk of ... Our results suggested that better adherence to overall and healthful plant-based diets was associated with a lower risk of CRC.