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.

The association between serum levels of micronutrients and the severity of disease in patients with COVID-19.

OBJECTIVES: This study aimed to compare the serum level of micronutrients with normal amounts, and assess their association with the severity of disease and inflammatory cytokines in patients with coronavirus disease 2019 (COVID-19). METHODS: The present cross-sectional study included 60 patients admitted to the intensive care unit with COVID-19. We recorded data on demographic characteristics, anthropometric information, and medical history. Serum levels of inflammatory markers (erythrocyte sedimentation rate, C-reactive protein, interferon-gamma, tumor necrosis factor-alpha, interleukin-6), vitamins (A, B9, B12, C, D, E), and minerals (magnesium, zinc, iron) were measured. A radiologist assessed the severity of lung involvement according to patient computed tomography scans. The severity of illness was evaluated with the Acute Physiologic Assessment and Chronic Health Evaluation (APACHE) score, oxygen saturation, and body temperature. Independent associations among the serum levels of micronutrients with the severity of COVID-19 were measured. RESULTS: Median patient age was 53.50 years (interquartile range, 12.75 years). Except for vitamin A and zinc, serum levels of other micronutrients were lower than the minimum normal. Patients with APACHE score ≥25 had a higher body mass index (P = 0.044), body temperature (P = 0.003), erythrocyte sedimentation rate (P = 0.008), C-reactive protein (P = 0.003), and lower oxygen saturation (P = 0.005), serum levels of vitamin D (P = < 0.001), and zinc (P = < 0.001) compared with patients with APACHE score <25. We found that lower serum levels of vitamin D, magnesium, and zinc were significantly and independently associated with higher APACHE scores (P = 0.001, 0.028, and < 0.001, respectively) and higher lung involvement (P = 0.002, 0.045, and < 0.001, respectively). CONCLUSIONS: Lower serum levels of vitamin D, zinc, and magnesium were involved in severe COVID-19.