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

NCT05658263 | Completed Early Phase 1 DMC

• 1 other identifier: SURG-2023-31051
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (18)

• Change in muscle mass

  The change in muscle mass assessed by MRI-measured area and density of the psoas muscle at the level of the L3 vertebra with adjunct grip strength measurement.

  baseline and 4 weeks after surgery

• Frequency of accidental gas leakage

  this will be assessed in times per day or times per month

  4 weeks after surgery

• Frequency of accidental mucus leakage

  this will be assessed in times per day or times per month

  4 weeks after surgery

• Frequency of accidental liquid stool leakage

  this will be assessed in times per day or times per month

  4 weeks after surgery

• Frequency of bowel movements

  this will be assessed in numbers per day or numbers per week

  4 weeks after surgery

• stool consistency

  Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid

  4 weeks after surgery

• Bowel emptying patterns

  (includes constipation, diarrhea, urgency; range: always--\> never)

  4 weeks after surgery

• Laxative/stool softener use

  Yes/No

  4 weeks after surgery

• Laxative/stool softener use

  times/day

  4 weeks after surgery

• Laxative/stool softener use

  times/week

  4 weeks after surgery

• Laxative/stool softener use

  times/month

  4 weeks after surgery

• Gastrointestinal comfort

  range: 0 (no problem) --\> 4 (very strong discomfort)

  24 hours before surgery

• Bowel emptying patterns

  includes constipation, diarrhea, urgency; range: 0 (never) --\> 4 (always)

  24 hours before surgery

• Laxative/stool softener use

  range; 0-4+ doses

  24 hours before surgery

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

  carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations

  baseline

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

  carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations

  postop day 7

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

  carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations

  postop day 30

• Compliance with the dietary intervention or standard of care- survey

  24-hour diet recall surveys conducted by Nutrition Coordinating Center at University of Minnesota

  4 weeks

Secondary Outcomes (8)

• Change in microbiome features- alpha diversity

  Baseline, time of surgery, postop day 7 and 30

• Change in microbiome features- beta diversity

  Baseline, time of surgery, postop day 7 and 30

• Fecal metabolites

  baseline and 4 weeks after surgery

• Fecal inflammatory markers

  Baseline and 4 weeks after surgery

• Changes in body composition- abdominal muscle

  Baseline, time of surgery, postop day 7 and 30

Study Arms (2)

Standard Diet

ACTIVE COMPARATOR

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).

Dietary Supplement: Standard Diet

BIG MACS Diet

EXPERIMENTAL

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.

Dietary Supplement: BIG MACS Diet

Interventions

Standard Diet 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).

Standard Diet

BIG MACS Diet 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.

BIG MACS Diet

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Dysbiosis; Sarcopenia; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Cyrus Jahansouz

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: December 20, 2022
• Study Start: January 3, 2023
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)