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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
14
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.
University of Minnesota
Minneapolis, Minnesota, United States
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.
Time frame: baseline and 4 weeks after surgery
Frequency of accidental gas leakage
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
Frequency of accidental mucus leakage
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
Frequency of accidental liquid stool leakage
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
Frequency of bowel movements
this will be assessed in numbers per day or numbers per week
Time frame: 4 weeks after surgery
stool consistency
Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid
Time frame: 4 weeks after surgery
Bowel emptying patterns
(includes constipation, diarrhea, urgency; range: always--\> never)
Time frame: 4 weeks after surgery
Laxative/stool softener use
Yes/No
Time frame: 4 weeks after surgery
Laxative/stool softener use
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times/day
Time frame: 4 weeks after surgery
Laxative/stool softener use
times/week
Time frame: 4 weeks after surgery
Laxative/stool softener use
times/month
Time frame: 4 weeks after surgery
Gastrointestinal comfort
range: 0 (no problem) --\> 4 (very strong discomfort)
Time frame: 24 hours before surgery
Bowel emptying patterns
includes constipation, diarrhea, urgency; range: 0 (never) --\> 4 (always)
Time frame: 24 hours before surgery
Laxative/stool softener use
range; 0-4+ doses
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks
Change in microbiome features- alpha diversity
Shannon, Simpson, and Chao1 indices
Time frame: Baseline, time of surgery, postop day 7 and 30
Change in microbiome features- beta diversity
compositionally corrected Aitchison's distances
Time frame: Baseline, time of surgery, postop day 7 and 30
Fecal metabolites
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
Fecal inflammatory markers
ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.
Time frame: Baseline and 4 weeks after surgery
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
Time frame: Baseline, time of surgery, postop day 7 and 30
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
Time frame: Baseline, time of surgery, postop day 7 and 30
Changes in body composition- volume of fat
MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue
Time frame: Baseline, time of surgery, postop day 7 and 30
Changes in body composition- liver fat
MRI-measured liver fat content
Time frame: Baseline, time of surgery, postop day 7 and 30