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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Diet | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Frequency of accidental gas leakage | this will be assessed in times per day or times per month | 4 weeks after surgery |
| Frequency of accidental mucus leakage | this will be assessed in times per day or times per month | 4 weeks after surgery |
| Frequency of accidental liquid stool leakage | this will be assessed in times per day or times per month | 4 weeks after surgery |
| Frequency of bowel movements | this will be assessed in numbers per day or numbers per week | 4 weeks after surgery |
| stool consistency | Bristol Stool Chart: Type 1 (hard lumps) through Type 7 (watery, no solid pieces, entirely liquid | 4 weeks after surgery |
| Bowel emptying patterns | (includes constipation, diarrhea, urgency; range: always--> never) | 4 weeks after surgery |
| Laxative/stool softener use |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome features- alpha diversity | Shannon, Simpson, and Chao1 indices | Baseline, time of surgery, postop day 7 and 30 |
| Change in microbiome features- beta diversity | compositionally corrected Aitchison's distances |
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Cyrus Jahansouz | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| D055948 | Sarcopenia |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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| 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. |
|
Yes/No
| 4 weeks after surgery |
| Laxative/stool softener use | times/day | 4 weeks after surgery |
| Laxative/stool softener use | times/week | 4 weeks after surgery |
| Laxative/stool softener use | times/month | 4 weeks after surgery |
| Gastrointestinal comfort | range: 0 (no problem) --> 4 (very strong discomfort) | 24 hours before surgery |
| Bowel emptying patterns | includes constipation, diarrhea, urgency; range: 0 (never) --> 4 (always) | 24 hours before surgery |
| Laxative/stool softener use | range; 0-4+ doses | 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 | 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 | 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 | 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 | 4 weeks |
| 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. | 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. | 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 | 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 | 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 | Baseline, time of surgery, postop day 7 and 30 |
| Changes in body composition- liver fat | MRI-measured liver fat content | Baseline, time of surgery, postop day 7 and 30 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |