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Dietary Supplement

BIG MACS Diet for Colon Cancer

Phase < 1

Waitlist Available

Led By Cyrus Jahansouz

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of colon cancer, stages 1-3

Age 25-70 years

Must not have

Previous organ transplantation

Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, time of surgery, postop day 7 and 30

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a special diet to help colorectal cancer surgery patients. The diet aims to improve outcomes by providing beneficial bacteria with more carbohydrates.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include gastrointestinal discomfort such as bloating or changes in bowel habits due to increased fiber intake from the BIG MACS Diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My colon cancer is in stage 1, 2, or 3.

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I am between 25 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant.

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I have HIV, active tuberculosis, malaria, hepatitis B or C, cirrhosis, or inflammatory bowel disease.

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I have had a severe infection in my abdomen before.

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I have had surgery on my stomach, intestines, pancreas, bile duct, gallbladder, or spleen.

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I have significant anemia or a history of bleeding disorders.

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I am 25 years old or younger, or 70 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, time of surgery, postop day 7 and 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, time of surgery, postop day 7 and 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, time of surgery, postop day 7 and 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bowel emptying patterns

Change in muscle mass

Compliance with the dietary intervention or standard of care- Baseline veggie meter

+8 more

Secondary study objectives

Change in microbiome features- alpha diversity

Change in microbiome features- beta diversity

Changes in body composition- abdominal muscle

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BIG MACS DietExperimental Treatment1 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 DietActive Control1 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).

0 / 8Eligibility criteria met