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Completed

NCT Number: NCT05658263

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. Change in muscle mass

    Time frame: baseline and 4 weeks after surgery

    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.

  2. Frequency of accidental gas leakage

    Time frame: 4 weeks after surgery

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

  3. Frequency of accidental mucus leakage

    Time frame: 4 weeks after surgery

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

  4. Frequency of accidental liquid stool leakage

    Time frame: 4 weeks after surgery

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

  5. Frequency of bowel movements

    Time frame: 4 weeks after surgery

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

  6. stool consistency

    Time frame: 4 weeks after surgery

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

  7. Bowel emptying patterns

    Time frame: 4 weeks after surgery

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

  8. Laxative/stool softener use

    Time frame: 4 weeks after surgery

    Yes/No

  9. Laxative/stool softener use

    Time frame: 4 weeks after surgery

    times/day

  10. Laxative/stool softener use

    Time frame: 4 weeks after surgery

    times/week

  11. Laxative/stool softener use

    Time frame: 4 weeks after surgery

    times/month

  12. Gastrointestinal comfort

    Time frame: 24 hours before surgery

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

  13. Bowel emptying patterns

    Time frame: 24 hours before surgery

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

  14. Laxative/stool softener use

    Time frame: 24 hours before surgery

    range; 0-4+ doses

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

    Time frame: baseline

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

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

    Time frame: postop day 7

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

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

    Time frame: postop day 30

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

  18. Compliance with the dietary intervention or standard of care- survey

    Time frame: 4 weeks

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

Secondary outcomes

  1. Change in microbiome features- alpha diversity

    Time frame: Baseline, time of surgery, postop day 7 and 30

    Shannon, Simpson, and Chao1 indices

  2. Change in microbiome features- beta diversity

    Time frame: Baseline, time of surgery, postop day 7 and 30

    compositionally corrected Aitchison's distances

  3. Fecal metabolites

    Time frame: baseline and 4 weeks after surgery

    Targeted fecal and serum metabolomics will measure changes in short chain fatty acids (SCFAs) and bile acids.

  4. Fecal inflammatory markers

    Time frame: Baseline and 4 weeks after surgery

    ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.

  5. Changes in body composition- abdominal muscle

    Time frame: Baseline, time of surgery, postop day 7 and 30

    total abdominal muscle area in cm squared. Absolute and relative change in total abdominal muscle area per patient over time (cm squared ), with the average change per patient group compared between study and control group

  6. Changes in body composition- psoas muscle

    Time frame: Baseline, time of surgery, postop day 7 and 30

    total psoas muscle area in cm squared. Absolute and relative change in total psoas muscle area per patient over time (cm squared ), with the average change per patient group compared between study and control group

  7. Changes in body composition- volume of fat

    Time frame: Baseline, time of surgery, postop day 7 and 30

    MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue

  8. Changes in body composition- liver fat

    Time frame: Baseline, time of surgery, postop day 7 and 30

    MRI-measured liver fat content

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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