search
Back to results

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

Primary Purpose

Dysbiosis, Sarcopenia, Colon Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Standard Diet
BIG MACS Diet
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysbiosis

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Diet

BIG MACS Diet

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.
Frequency of accidental gas leakage
this will be assessed in times per day or times per month
Frequency of accidental mucus leakage
this will be assessed in times per day or times per month
Frequency of accidental liquid stool leakage
this will be assessed in times per day or times per month
Frequency of bowel movements
this will be assessed in numbers per day or numbers per week
stool consistency
Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid
Bowel emptying patterns
(includes constipation, diarrhea, urgency; range: always--> never)
Laxative/stool softener use
Yes/No
Laxative/stool softener use
times/day
Laxative/stool softener use
times/week
Laxative/stool softener use
times/month
Gastrointestinal comfort
range: 0 (no problem) --> 4 (very strong discomfort)
Bowel emptying patterns
includes constipation, diarrhea, urgency; range: 0 (never) --> 4 (always)
Laxative/stool softener use
range; 0-4+ doses
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
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
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
Compliance with the dietary intervention or standard of care- survey
24-hour diet recall surveys conducted by Nutrition Coordinating Center at University of Minnesota

Secondary Outcome Measures

Change in microbiome features- alpha diversity
Shannon, Simpson, and Chao1 indices
Change in microbiome features- beta diversity
compositionally corrected Aitchison's distances
Fecal metabolites
Targeted fecal and serum metabolomics will measure changes in short chain fatty acids (SCFAs) and bile acids.
Fecal inflammatory markers
ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.
Changes in body composition- abdominal muscle
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
Changes in body composition- psoas muscle
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
Changes in body composition- volume of fat
MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue
Changes in body composition- liver fat
MRI-measured liver fat content

Full Information

First Posted
October 11, 2022
Last Updated
January 4, 2023
Sponsor
University of Minnesota
search

1. Study Identification

Unique Protocol Identification Number
NCT05658263
Brief Title
Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
Official Title
Bacterial Intestinal Gut Modification Around Cancer Surgery (BIG MACS) Diet
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbiosis, Sarcopenia, Colon Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Diet
Arm Type
Active Comparator
Arm Description
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).
Arm Title
BIG MACS Diet
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Standard Diet
Intervention Description
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
Intervention Name(s)
BIG MACS Diet
Intervention Description
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 Outcome Measure Information:
Title
Change in muscle mass
Description
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.
Time Frame
baseline and 4 weeks after surgery
Title
Frequency of accidental gas leakage
Description
this will be assessed in times per day or times per month
Time Frame
4 weeks after surgery
Title
Frequency of accidental mucus leakage
Description
this will be assessed in times per day or times per month
Time Frame
4 weeks after surgery
Title
Frequency of accidental liquid stool leakage
Description
this will be assessed in times per day or times per month
Time Frame
4 weeks after surgery
Title
Frequency of bowel movements
Description
this will be assessed in numbers per day or numbers per week
Time Frame
4 weeks after surgery
Title
stool consistency
Description
Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid
Time Frame
4 weeks after surgery
Title
Bowel emptying patterns
Description
(includes constipation, diarrhea, urgency; range: always--> never)
Time Frame
4 weeks after surgery
Title
Laxative/stool softener use
Description
Yes/No
Time Frame
4 weeks after surgery
Title
Laxative/stool softener use
Description
times/day
Time Frame
4 weeks after surgery
Title
Laxative/stool softener use
Description
times/week
Time Frame
4 weeks after surgery
Title
Laxative/stool softener use
Description
times/month
Time Frame
4 weeks after surgery
Title
Gastrointestinal comfort
Description
range: 0 (no problem) --> 4 (very strong discomfort)
Time Frame
24 hours before surgery
Title
Bowel emptying patterns
Description
includes constipation, diarrhea, urgency; range: 0 (never) --> 4 (always)
Time Frame
24 hours before surgery
Title
Laxative/stool softener use
Description
range; 0-4+ doses
Time Frame
24 hours before surgery
Title
Compliance with the dietary intervention or standard of care- Baseline veggie meter
Description
carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations
Time Frame
baseline
Title
Compliance with the dietary intervention or standard of care- Baseline veggie meter
Description
carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations
Time Frame
postop day 7
Title
Compliance with the dietary intervention or standard of care- Baseline veggie meter
Description
carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations
Time Frame
postop day 30
Title
Compliance with the dietary intervention or standard of care- survey
Description
24-hour diet recall surveys conducted by Nutrition Coordinating Center at University of Minnesota
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in microbiome features- alpha diversity
Description
Shannon, Simpson, and Chao1 indices
Time Frame
Baseline, time of surgery, postop day 7 and 30
Title
Change in microbiome features- beta diversity
Description
compositionally corrected Aitchison's distances
Time Frame
Baseline, time of surgery, postop day 7 and 30
Title
Fecal metabolites
Description
Targeted fecal and serum metabolomics will measure changes in short chain fatty acids (SCFAs) and bile acids.
Time Frame
baseline and 4 weeks after surgery
Title
Fecal inflammatory markers
Description
ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.
Time Frame
Baseline and 4 weeks after surgery
Title
Changes in body composition- abdominal muscle
Description
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
Time Frame
Baseline, time of surgery, postop day 7 and 30
Title
Changes in body composition- psoas muscle
Description
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
Time Frame
Baseline, time of surgery, postop day 7 and 30
Title
Changes in body composition- volume of fat
Description
MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue
Time Frame
Baseline, time of surgery, postop day 7 and 30
Title
Changes in body composition- liver fat
Description
MRI-measured liver fat content
Time Frame
Baseline, time of surgery, postop day 7 and 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyrus Jahansouz, MD
Phone
612-899-2176
Email
jahan023@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Kohn, MD
Phone
612-293-0201
Email
kohn0103@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyrus Jahansouz
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus Jahansouz, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs