BIG MACS Diet for Colon Cancer

Overseen By Julia Kohn, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Anemia, Coagulopathy, Alcoholism, Obesity, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special diet called the BIG MACS Diet, designed to aid individuals undergoing surgery for colon cancer. Researchers aim to determine if consuming more gut-friendly foods before and after surgery can enhance recovery. Participants will either follow the new diet plan or adhere to standard nutrition advice. The trial seeks individuals with stage 1-3 colon cancer who are about to undergo surgery and can meet the study's dietary and visit requirements. As an Early Phase 1 trial, this research focuses on understanding the diet's impact on recovery, offering participants an opportunity to contribute to groundbreaking nutritional science.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that the BIG MACS Diet is likely to be safe for humans?

Research has shown that diets high in fiber, like the BIG MACS Diet, are linked to a lower risk of colorectal cancer. Studies have found that more fiber and certain foods, like yogurt, can help reduce the risk of colon cancer. This suggests that the BIG MACS Diet, which aims to increase certain carbohydrates that support gut health, might be helpful.

Since the BIG MACS Diet is being tested in an early phase of clinical trials, clear information on its safety is not yet available. Early-stage trials mainly focus on tolerance, so researchers are checking for any negative reactions or side effects.

In summary, while positive evidence exists for diets similar to the BIG MACS Diet, the specific safety of this diet is still under study in this early trial. Participants' feedback will be crucial in determining how well the diet is tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the BIG MACS Diet for colon cancer because it offers a dietary approach rather than relying solely on traditional treatments like chemotherapy and radiation. Unlike standard nutritional advice, which typically focuses on basic dietary guidelines and protein shakes, the BIG MACS Diet is specifically structured to be followed both before and after surgery, potentially enhancing recovery and outcomes. This unique focus on nutrition as a significant part of cancer care could lead to a better quality of life and improved recovery times for patients.

What evidence suggests that the BIG MACS Diet might be an effective treatment for colon cancer?

Research has shown that dietary changes can affect colon cancer outcomes. Increasing fruit and vegetable intake while reducing meat and sweets can lower the risk of colorectal cancer. In this trial, participants will follow different diet plans. One group will adhere to the BIG MACS Diet, which aims to improve gut health by increasing certain carbohydrates that support beneficial gut bacteria. This approach might aid recovery from colon cancer surgery. Early studies suggest that following this diet before and after surgery could lead to better results. Another group will receive standard nutrition advice. Although specific data on the BIG MACS Diet's effectiveness is still being gathered, the concept is based on evidence linking diet to cancer outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Cyrus Jahansouz, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 25-70 with a primary diagnosis of colon cancer stages 1-3, who can consent and follow the study protocol. Excluded are those with significant health issues like anemia or liver problems, BMI <20 or >40, psychiatric conditions affecting adherence, history of substance dependency within five years, certain surgeries or diseases (like IBD), and pregnant/nursing individuals.

Inclusion Criteria

Able to comply with study measures

English-speaking

Willingness to return to the study site for specified study visits at D7 and D30

Exclusion Criteria

You had problems with alcohol, drugs, or opioids, except for smoking, in the last five years.

You are in prison.

Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Diet

Participants follow either the standard diet or the BIG MACS Diet with one protein shake per day for 4 weeks prior to surgery

4 weeks

Post-surgery Diet

Participants continue the BIG MACS Diet for an additional four weeks after surgery, with solid food reintroduction as early as tolerated

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of bowel movements, muscle mass, and microbiome changes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIG MACS Diet

Trial Overview The BIG MACS Diet aims to optimize gut microbiome before colorectal surgery by providing more microbiota accessible carbohydrates compared to a standard diet. The goal is to see if this special diet improves patient outcomes after surgery.

How Is the Trial Designed?

Group I: BIG MACS Diet Experimental Treatment 1 Intervention

Participants will be instructed to consume the study diet, referred to as the 'BIG MACS Diet' and one protein shake per day for 4 weeks prior to surgery (SOC). Following surgery, participants will continue to follow the BIG MACS Diet for an additional four weeks, with solid food reintroduction after surgery as early as tolerated.

Group II: Standard Diet Active Control 1 Intervention

Participants receiving only standard of care (SOC) nutrition advice, which is SOC Dietary Instructions, as provided by routine surgical consults and one protein shake per day for 4 weeks prior to surgery (SOC).

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5794031/

Dietary Patterns and Colorectal Cancer Risk: A Review of 17 ... Consuming a dietary pattern high in fruits and vegetables and low in meats and sweets is protective against CRC risk.

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00304

Bacterial Intestinal Gut Modification Around ... Following the BIG MACS diet before and after surgery may improve outcomes for patients with colon cancer undergoing surgery. Eligibility Criteria ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12107496/

Dietary patterns and colorectal cancer risk By cancer subsite, higher alignment with Mediterranean diet showed limited–suggestive evidence for lower rectal cancer risk, and that with HEI/alternate HEI and ...

4. nutritionfacts.org nutritionfacts.org/video/friday-favorites-the-best-dietary-changes-for-colon-cancer-prevention/

Friday Favorites: The Best Dietary Changes for Colon Cancer ... A plant-based diet may result in more beneficial metabolizes in the bloodstream and less of the bad stuff.

5. withpower.com withpower.com/trial/early-phase-1-dysbiosis-2023-2a243

BIG MACS Diet for Colon Cancer · Info for Participants This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9836915/

Association between Diet-related Behaviour and Risk of ... Two studies have shown that higher meal frequency was associated with lower colon cancer risk among subjects with higher insulin sensitivity, a higher physical ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2776517

Role of Diet in Colorectal Cancer Incidence This umbrella review found convincing evidence of an association between lower CRC risk and higher intakes of dietary fiber, dietary calcium, and yogurt.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0002916525000140

Dietary-Lifestyle Patterns and Colorectal Cancer Risk Most studies examining dietary-lifestyle patterns based on specific recommendations for cancer prevention found an inverse direction of association with CRC, ...