Plant-Based Diet for Colorectal Cancer
(DIET Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Chicago
Must not be taking: Antibiotics, Prebiotics, Probiotics, others
Disqualifiers: Ostomy, Separate malignancy, Pregnancy, others
No Placebo Group
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.
12345Is 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.
26789How 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.
2671011Eligibility 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
+3 more
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.
+6 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Dietary Intervention ParticipantsExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Cereal fiber, calcium, and colorectal cancer. [2019]Food intake during the preceding 15 years was evaluated in detail in 41 patients treated for colorectal cancer and an equal number of matched control subjects by means of a dietary history technique that permitted quantitation of nutrients. Dietary habits of the control group could be compared against two larger groups of 371 hospital control and 430 population control subjects. Patients with cancer, who were interviewed after complete recovery from surgery, consumed more fat, protein, and carbohydrates, and thus more energy, than control subjects although these differences were not statistically significant. Per unit energy, the habitual diet of patients with cancer contained less cereal fiber (P less than 0.001), less riboflavin (P less than 0.05), less calcium (P less than 0.05), and less phosphorus (P less than 0.05) than the diet of the control subjects. A high intake of either cereal fiber, total fiber, calcium, and phosphorus in relation to energy intake was found to be associated with a reduced risk ratio of colorectal cancer. For colon cancer separately, a high intake of calcium and cereal fiber was associated with a reduced risk ratio. For rectal cancer, a high intake of total fiber and cereal fiber was associated with a reduced risk ratio. High alcohol consumption correlated with an increased risk ratio. These data are compatible with previous Scandinavian studies relating food consumption to the incidence and mortality of colorectal cancer.
Healthy and unhealthy plant-based diets in relation to the incidence of colorectal cancer overall and by molecular subtypes. [2022]Plant-based foods have been recommended for health. However, not all plant foods are healthy, and little is known about the association between plant-based diets and specific molecular subtypes of colorectal cancer (CRC). We examined the associations of healthy and unhealthy plant-based diets with the incidence of CRC and its molecular subtypes.
[Peri- and postoperative nutrition in colorectal cancer patients]. [2019]Peri- and postoperative nutrition in colorectal cancer patients Abstract. The long multimodal therapy regimens for colorectal cancer require a sufficient nutritional status of the patient. The "Enhanced Recovery After Surgery" concept aims for minimization of the interruption of nutrient intake and has been validated prospectively. Preoperative malnutrition as a strong risk factor for complications should be detected and treated early after cancer diagnosis by screening tools as the "Nutritional Risk Screening" (NRS-2002) or the "Malnutrition Universal Screening Tool" (MUST). High-caloric oral supplementation, enteral nutrition and parenteral nutrition are possible measures, which should be escalated stepwise. The recent concept of "prehabilitation" additionally includes short‑term optimization of the physical and psychological status. Postoperative attention should be paid to possible deficiency syndromes of single nutrients due to reduced resorption after bowel segment resection or stoma creation. Risk- and preventive factors in primary prevention of colorectal carcinoma are well-known, in secondary prevention knowledge is less clear. There is only low evidence for a positive effect of omega-3 fatty acids, coffee, high-fiber diet and vitamin D in secondary prevention of colorectal carcinoma, requiring further studies.
Effect of a one-year personalized intensive dietary intervention on body composition in colorectal cancer patients: Results from a randomized controlled trial. [2023]Changes in body composition may affect colorectal cancer (CRC) patient's risk of cancer recurrence, secondary cancer, and other chronic diseases. The suggested interventions for changes in body composition such as low muscle mass or high fat mass, are diet and physical activity. Nevertheless, there is limited evidence of how dietary intervention alone can impact body composition. This study aimed to investigate the effect of a 6 and 12 month dietary intervention with a focus on healthy eating according to Norwegian food-based dietary guidelines on weight and body composition in patients with CRC stage I-III, post-surgery.
Excessive fat restriction might promote the recurrence of colorectal tumors. [2022]The incidence of colorectal cancer is rapidly increasing in Japan. This trend has been suggested to be caused by an increasing fat intake as a result of the Westernized diet among Japanese. We investigated whether dietary instruction optimizing the fat energy ratio suppresses the recurrence of colorectal tumors. The subjects, 373 men and women, were the participants in a randomized clinical trial of colorectal cancer prophylaxis. At entry, each participant completed a 3-consecutive-day food record on which dietary instruction was given to restrict fat energy ratio to 18-22%. Data obtained before and after the intervention were examined by cohort analysis. The primary endpoint was the presence or absence of colorectal tumor(s) at colonoscopy after 4 yr. Unexpectedly, the recurrence of tumor increased as the subjects reduced their fat intake. The lowest tumor recurrence among the men was observed in the group with 23.8-26.4% fat energy ratio after the intervention. Furthermore, in men, the risk of tumors decreased significantly as the intake of linoleic acids per body weight increased. For women, similar trends were observed. These results suggest that extreme fat restriction is highly likely to promote the recurrence of colorectal tumors, which may be partly attributable to linoleic acid deficiency.
Colon cancer overview. [2019]The scope of current prevention research support by the National Cancer Institute includes the clinical assessment of dietary modifications and cancer screening trials, epidemiologic studies, development of new chemopreventive therapies, and the use of advanced molecular biologic technologies to probe the genetic determinants of colorectal adenomas. Colorectal cancer frequently has been associated with high-fat low-fiber diets in epidemiologic and experimental studies. A recently initiated Phase III Dietary Intervention Study of Recurrence of Large Bowel Adenomatous Polyps will investigate the potential benefits of a low-fat high-fiber fruit-and-vegetable-enriched eating pattern to decrease the polyp recurrence rate. The Chemoprevention Program currently is supporting four Phase III controlled clinical intervention trials investigating the cancer-inhibiting effects on colorectal cancer of beta-carotene, piroxicam, calcium, and calcium plus fiber in persons with previous adenomas. A proposed early detection trial will screen for colorectal, prostate, lung, and ovarian cancers. A comparison of incidence and mortality trends indicates progress in colorectal cancer detection and therapy.
Fiber, Fat, and Colorectal Cancer: New Insight into Modifiable Dietary Risk Factors. [2023]To review recent data on the role and interactions of fiber and fat as dietary risk factors associated with colorectal cancer (CRC) risk in humans.
Dietary fibre to reduce colon cancer risk in Alaska Native people: the Alaska FIRST randomised clinical trial protocol. [2021]Diet, shown to impact colorectal cancer (CRC) risk, is a modifiable environmental factor. Fibre foods fermented by gut microbiota produce metabolites that not only provide food for the colonic epithelium but also exert regulatory effects on colonic mucosal inflammation and proliferation. We describe methods used in a double-blinded, randomised, controlled trial with Alaska Native (AN) people to determine if dietary fibre supplementation can substantially reduce CRC risk among people with the highest reported CRC incidence worldwide.
Plant-based dietary patterns defined by a priori indices and colorectal cancer risk by sex and race/ethnicity: the Multiethnic Cohort Study. [2023]Plant-based diets assessed by a priori indices are associated with health outcomes. This study investigated the associations between pre-defined indices of plant-based diets and risk of colorectal cancer (CRC) and evaluated whether the association varies by sex, race and ethnicity, and anatomic subsite of tumors.
Case-control study of proximal and distal colon cancer and diet in Wisconsin. [2019]The relationship between diet and subsite-specific colon cancer was investigated using dietary histories obtained from a statewide, population-based sample of 152 proximal colon cancer patients, 201 distal colon cancer patients and 618 general population controls. The results do not support hypotheses that (1) dietary fat and cholesterol are more strongly related to proximal colon cancer and (2) vegetables and other dietary sources of fiber are more strongly associated with distal colon cancer. Vegetable consumption over lifetime was consistently protective for both proximal and distal colon cancer. Odds ratios and 95% confidence intervals for the most significant dietary factors (based on high vs. low consumption) for proximal colon cancer were: salad, 0.29 (0.17, 0.48); miscellaneous vegetables, 0.58 (0.35, 0.97); cruciferous vegetables, 0.59 (0.35, 0.97); processed lunchmeat, 2.04 (1.31, 3.17); pan-fried foods, 1.79 (1.15, 2.80); eggs, 1.75 (1.02, 2.99) and for distal colon cancer they were: salad, 0.43 (0.28, 0.67); cruciferous vegetables, 0.44 (0.28, 0.71); cheese, 0.62 (0.40, 0.96); processed lunchmeat, 1.79 (1.17, 2.73); pan-fried foods, 1.55 (1.03, 1.27). The results support recommendations that the "prudent diet" (low-fat, high-vegetable) may reduce colon cancer risk.
A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors. [2018]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 (CRC) survivors and low reported intake of whole grains and legumes, practical strategies to increase consumption merit attention. This study determined feasibility of increasing NB or RB intake in CRC survivors to increase dietary fiber and examined serum inflammatory biomarkers and telomere lengths. Twenty-nine subjects completed a randomized controlled trial with foods that included cooked NB powder (35 g/day), heat-stabilized RB (30 g/day), or no additional ingredient. Fasting blood, food logs, and gastrointestinal health questionnaires were collected. The amount of NB or RB consumed equated to 4-9% of subjects' daily caloric intake and no major gastrointestinal issues were reported with increased consumption. Dietary fiber amounts increased in NB and RB groups at Weeks 2 and 4 compared to baseline and to control (P ≤ 0.01). Telomere length correlated with age and HDL cholesterol at baseline, and with improved serum amyloid A (SAA) levels at Week 4 (P ≤ 0.05). This study concludes feasibility of increased dietary NB and RB consumption to levels associated with CRC chemoprevention and warrants longer-term investigations with both foods in high-risk populations that include cancer prevention and control outcomes.