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Dietary Supplement
BIG MACS Diet for Colon Cancer
Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, time of surgery, postop day 7 and 30
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My colon cancer is in stage 1, 2, or 3.
Select...
I am between 25 and 70 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bowel emptying patterns
Change in muscle mass
Compliance with the dietary intervention or standard of care- Baseline veggie meter
+8 moreSecondary outcome measures
Change in microbiome features- alpha diversity
Change in microbiome features- beta diversity
Changes in body composition- abdominal muscle
+5 moreTrial 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).
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,485 Total Patients Enrolled
Cyrus JahansouzPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had problems with alcohol, drugs, or opioids, except for smoking, in the last five years.You are in prison.You drink more than one alcoholic drink per day if you're a woman, or more than 20 grams per day if you're a woman, or more than 30 grams per day if you're a man.I have HIV, active tuberculosis, malaria, hepatitis B or C, cirrhosis, or inflammatory bowel disease.I have depression with a CES-D score over 16 and am not considered suitable for surgery by a psychologist.My colon cancer is in stage 1, 2, or 3.I have had an organ transplant.I have had a severe infection in my abdomen before.Your blood test shows that your creatinine level is higher than 1.5 mg/dL.Your blood tests show high levels of bilirubin, alkaline phosphatase, ALT, AST, or INR.I have had surgery on my stomach, intestines, pancreas, bile duct, gallbladder, or spleen.I have significant anemia or a history of bleeding disorders.Your BMI is less than 20 or more than 40.I am 25 years old or younger, or 70 years old or older.My surgery is not for removing colon cancer, preparing for other treatments, or my first treatment.I am between 25 and 70 years old.You have a history of feeling very scared in small, enclosed spaces.You have any type of implant that is not safe for MRI scans, like a pacemaker or metallic hardware.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Diet
- Group 2: BIG MACS Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric individuals being included in the recruitment process of this research project?
"Aspiring participants for this study must be between 25 and 70 years old."
Answered by AI
Who meets the criteria to be a part of this research endeavor?
"To qualify for this medical experiment, individuals must have dysbiosis and be aged between 25 to 70. The investigators are currently searching for a total of 24 study participants."
Answered by AI
Does this experiment presently admit volunteers?
"Clinicaltrials.gov indicates that this medicla study, which was initially posted on January 15th 2023 and last updated on December 19th 2022, is presently not recruiting patients. However, there are currently 278 other trials searching for participants at the moment."
Answered by AI
What are the intended outcomes of this medical experiment?
"Through a baseline and 4-week post-surgical assessment, this study seeks to assess the incidence of accidental gas leakage. Additionally, Aitchison's distances will be used to calculate beta diversity in microbial communities; ELISA analysis is utilized for quantifying fecal inflammatory markers such as calprotectin and IgA levels; finally, targeted metabolomics research shall measure changes found in short chain fatty acids (SCFAs) and bile acids."
Answered by AI
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