University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT05658263
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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Notify Me25 year–70 year
All sexes
Interventional
Early Phase 1
Minneapolis, Minnesota, 55455, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
Time frame: 4 weeks after surgery
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
this will be assessed in times per day or times per month
Time frame: 4 weeks after surgery
this will be assessed in numbers per day or numbers per week
Time frame: 4 weeks after surgery
Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid
Time frame: 4 weeks after surgery
(includes constipation, diarrhea, urgency; range: always--> never)
Time frame: 4 weeks after surgery
Yes/No
Time frame: 4 weeks after surgery
times/day
Time frame: 4 weeks after surgery
times/week
Time frame: 4 weeks after surgery
times/month
Time frame: 24 hours before surgery
range: 0 (no problem) --> 4 (very strong discomfort)
Time frame: 24 hours before surgery
includes constipation, diarrhea, urgency; range: 0 (never) --> 4 (always)
Time frame: 24 hours before surgery
range; 0-4+ doses
Time frame: baseline
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
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
carotenoid score, triplicate measurement; range: 0 (lower estimated value)-800 (arbitrary units; higher estimated value correlates with greater carotenoid concentrations
Time frame: 4 weeks
24-hour diet recall surveys conducted by Nutrition Coordinating Center at University of Minnesota
Time frame: Baseline, time of surgery, postop day 7 and 30
Shannon, Simpson, and Chao1 indices
Time frame: Baseline, time of surgery, postop day 7 and 30
compositionally corrected Aitchison's distances
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.
Time frame: Baseline and 4 weeks after surgery
ELISA. Fecal calprotectin and IgA levels will be measured using ELISA as markers of intestinal inflammation.
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
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
Time frame: Baseline, time of surgery, postop day 7 and 30
MRI-measured area (cm2) and volume (L) of subcutaneous and visceral adipose tissue
Time frame: Baseline, time of surgery, postop day 7 and 30
MRI-measured liver fat content
University of Minnesota
Other
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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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