The Effect of Mediterranean Diet on Body Composition, Inflammatory Factors, and Nutritional Status in Patients with Cachexia Induced by Colorectal Cancer: A Randomized Clinical Trial.

BACKGROUND: Along with high calorie and high protein diet, a new comprehensive dietary approach is needed to control cachexia caused by cancer and its related outcomes. This study was done to evaluate the effect of a Mediterranean diet on body composition, nutritional status, and inflammatory markers among cancer cachexia patients. METHODS: In this randomized clinical trial, 46 patients with colorectal cancer-induced cachexia were included. After randomization, 23 patients were allocated to the intervention group (Mediterranean diet) and 23 to the control group (nutritional counseling for weight gain and prevention of weight loss in cancer patients). The primary outcome including muscle health, nutritional status, and inflammatory markers along with secondary outcomes such as quality of life, and serum proteins were evaluated at the start and the eighth week of the study. Statistical analysis was performed according to the intention-to-treat concept. To compare changes in dependent variables between the 2 groups, analysis of covariance (ANCOVA) was performed. RESULTS: After adjustment for the baseline values, age, sex, and supplements use, in the Mediterranean diet group mean of weight (P < .001), lean body mass (P = .001), fat mass (P = .002), and muscle strength (P < .001) were significantly increased compared to the control group. Regarding inflammatory markers, the mean serum level of tumor necrosis factor-alpha (TNF-α) (P < .001), high sensitive-C-reactive protein (hs-CRP) (P = .01) and Interleukin 6 (IL-6) (P < .001) were significantly improved in the Mediterranean diet group. Moreover, in the Mediterranean diet group, the score for global health status (P = .02) and physical performance score (P < .001) were significantly increased. CONCLUSION: It appears that the implementation of the Mediterranean diet might be a strategy to improve nutritional status, quality of life, inflammatory markers, and body composition in patients with colorectal cancer cachexia. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (www.irct.ir); ID: IRCT20211027052884N1.

The effect of Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer-induced cachexia: study protocol for a randomized clinical trial.

BACKGROUND: Current dietary strategies to manage cancer cachexia and the relevant outcomes did not provide a comprehensive solution. This study will evaluate the effect of a Mediterranean diet on inflammatory markers, nutritional status, muscle mass, and strength among patients with cancer cachexia (CC). METHODS: This will be a randomized clinical trial involving men and women diagnosed with localized or advanced colorectal cancer-induced cachexia. In total, 40 patients with CC will be recruited based on inclusion criteria and then these patients will be randomly allocated to receive either a Mediterranean diet (n = 20) or only routine nutritional advice (n = 20) for 8 weeks. The primary outcome will be nutritional status, muscle mass and strength, and serum concentrations of inflammatory markers including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and high-sensitive C-reactive protein (hs-CRP). Moreover, we will consider serum albumin and total protein levels, complete blood count (CBC), and quality of life as the secondary outcomes. All outcomes will be measured at the beginning and end (the eighth week) of the study. We will assess participants' adherence to the prescribed diets by using a 1-day food record in the second, fourth, sixth, and eighth weeks of the study. DISCUSSION: Along with adequate calorie and protein intake in cancer cachexia, reducing inflammatory cytokines might be a useful strategy for maintaining nutritional status and body composition. Mediterranean diet has been shown to have anti-inflammatory properties, and by its components, it might help patients with cachexia to have a better nutritional status and quality of life. TRIAL REGISTRATION: Iranian Registry of Clinical Trials ( www.irct.ir ) RCT20211027052884N1. Prospectively registered on November 09, 2021.