NCT05658263

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysbiosis
• Sarcopenia
• Colon Cancer

Interventions

Type	Name	Description
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).
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2023-01-03
• Primary completion: 2024-08-15
• Completion: 2024-08-15
• First posted: 2022-12-20
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States