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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The long-term study objective is to develop optimized nutritional therapies for surgery and test them in clinical practice. This pilot study will test a microbiome-optimization diet in colorectal cancer surgery patients. The study hypothesizes that the Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet will provide participants with increased microbiota accessible carbohydrates (MACs) to support the microbiome and improve outcomes.

Research Team

Cyrus Jahansouz, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+