Pilot Study of a Modified Mediterranean Diet Versus Standard Western Diet in Adults With Metastatic Colorectal Cancer Receiving Chemotherapy

What this Trial Is About

Researchers are evaluating how a Modified Mediterranean Diet affects the diversity of gut bacteria in patients with metastatic colorectal cancer who are receiving chemotherapy with or without biological agents. The study compares this diet to a typical Western or standard diet to understand its influence on protecting the intestinal barrier and its potential impact on disease side effects and quality of life. Participants will be randomly assigned to one of two groups one following the Modified Mediterranean Diet, which emphasizes high-quality prebiotic fibers but reduces total fiber intake to ease chemotherapy side effects, and the other continuing their usual Western diet. The study includes a screening visit, a baseline visit where nutritional status and various measurements are taken, and follow-up visits approximately every 15 to 21 days. Stool samples will be collected at about 45 days and 90 days after baseline, with radiological re-evaluations performed as part of routine care. During the study, patients will undergo nutritional assessments, blood tests, bioimpedance analysis, and lifestyle evaluations. Researchers will monitor changes in gut microbiota composition, gastrointestinal side effects, and quality of life over time. The primary outcome is the effect of the diet on microbiota after 45 days, with additional measures including changes in microbiome composition and metabolome at baseline, 45 days, and 90 days. The total participation period includes visits up to 90 days after starting the diet intervention.

Study on the Impact of a Modified Mediterranean Diet, in Patients With Colorectal Cancer Undergoing Active Medical Oncology Treatment