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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658263
• Other study ID #: HRP-590
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 3, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: Cyrus Jahansouz, MD
• Phone: 612-899-2176
• Email: jahan023[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 15, 2025
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Dysbiosis
• Sarcopenia

Intervention

Dietary Supplement:
• 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).
• 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Frequency of accidental gas leakage	this will be assessed in times per day or times per month	4 weeks after surgery
Primary	Frequency of accidental mucus leakage	this will be assessed in times per day or times per month	4 weeks after surgery
Primary	Frequency of accidental liquid stool leakage	this will be assessed in times per day or times per month	4 weeks after surgery
Primary	Frequency of bowel movements	this will be assessed in numbers per day or numbers per week	4 weeks after surgery
Primary	stool consistency	Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid	4 weeks after surgery
Primary	Bowel emptying patterns	(includes constipation, diarrhea, urgency; range: always--> never)	4 weeks after surgery
Primary	Laxative/stool softener use	Yes/No	4 weeks after surgery
Primary	Laxative/stool softener use	times/day	4 weeks after surgery
Primary	Laxative/stool softener use	times/week	4 weeks after surgery
Primary	Laxative/stool softener use	times/month	4 weeks after surgery
Primary	Gastrointestinal comfort	range: 0 (no problem) --> 4 (very strong discomfort)	24 hours before surgery
Primary	Bowel emptying patterns	includes constipation, diarrhea, urgency; range: 0 (never) --> 4 (always)	24 hours before surgery
Primary	Laxative/stool softener use	range; 0-4+ doses	24 hours before surgery
Primary	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
Primary	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
Primary	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
Primary	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	Change in microbiome features- alpha diversity	Shannon, Simpson, and Chao1 indices	Baseline, time of surgery, postop day 7 and 30
Secondary	Change in microbiome features- beta diversity	compositionally corrected Aitchison's distances	Baseline, time of surgery, postop day 7 and 30
Secondary	Fecal metabolites	Targeted fecal and serum metabolomics will measure changes in short chain fatty acids (SCFAs) and bile acids.	baseline and 4 weeks after surgery
Secondary	Fecal inflammatory markers	ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.	Baseline and 4 weeks after surgery
Secondary	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	Baseline, time of surgery, postop day 7 and 30
Secondary	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	Baseline, time of surgery, postop day 7 and 30
Secondary	Changes in body composition- volume of fat	MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue	Baseline, time of surgery, postop day 7 and 30
Secondary	Changes in body composition- liver fat	MRI-measured liver fat content	Baseline, time of surgery, postop day 7 and 30