Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet

NCT ID: NCT05658263

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2024-08-15

Brief Summary

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.

Conditions

Dysbiosis; Sarcopenia; Colon Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard Diet

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).

Group Type: ACTIVE_COMPARATOR

Standard Diet

Intervention Type: DIETARY_SUPPLEMENT

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).

BIG MACS Diet

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 Type: EXPERIMENTAL

BIG MACS Diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Standard Diet

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).

Intervention Type: DIETARY_SUPPLEMENT

BIG MACS Diet

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age 25-70 years
• Primary diagnosis of colon cancer, stages 1-3.
• Able and willing to provide informed consent.
• English-speaking.
• Willingness to return to the study site for specified study visits at D7 and D30.
• Able to comply with study measures.

Exclusion Criteria

• Age ≤ 25 years or ≥70 years
• If surgery is being performed for any reason other than resection of colon cancer. Neoadjuvant therapy, or if surgery is not the initial approach for the patient's colon cancer treatment
• Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy: any personal history of hereditary or acquired bleeding disorder, or thrombocytopenia with platelets under 100,000.
• Serum creatinine greater than 1.5 mg/dL.
• Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome or alkaline phosphatase or ALT or AST greater than 2.5 times the upper limit of normal. Elevated INR (1.5 or above).
• Alcohol intake more than one drink or greater than 20 grams per day for women or 30 grams per day for men.
• History of gastrointestinal surgery including stomach, small bowel or colon resection, pancreatic surgery, bile duct or gallbladder surgery, or splenectomy, or gastric bypass.
• History of intra-abdominal sepsis.
• Previous organ transplantation.
• Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
• Currently pregnant or nursing.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Depression: A CES-D score more than 16 and a psychologist determining that the patient is not a good fit for surgery.
• Body mass index (BMI) <20 or > 40 kilograms per meter squared:

obesity is known to impact the microbiome and immune system and the occurrence of anastomotic leak, and extreme obesity may confound interpretation of these factors in association to leak. Inferences may be made by matching participants with less severe obesity (BMI <40).

• Presence of any type of non-MRI compatible implant, including cardiac pacemakers or defibrillators, neurostimulators, cochlear implants, or other metallic hardware
• Self-reported history of claustrophobia.
• Incarceration
• Inability to adhere to the study protocol, procedures, and diet
• Exclusions may also be made at the discretion of the attending physician.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyrus Jahansouz

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

SURG-2023-31051

Identifier Type: -

Identifier Source: org_study_id