Mediterranean Diet Implementation to Protect against Advanced Lung Cancer Index (ALI) Rise: Study Design and Preliminary Results of a Randomised Controlled Trial

Abstract

The Mediterranean diet (MD) has been inversely associated with lung cancer (LC) risk. Hereby we show the preliminary results of our prospective randomised controlled trial in inflammatory and nutritional status of LC patients after 3-month implementation of MD. In total, 30 patients with small-cell or non-small-cell LC (stages III–IV) were enrolled. They were randomly assigned either to Control group, receiving general nutritional guidelines, or the MD group, in which a personalised MD plan was provided. Medical and dietary history, anthropometrics, blood biomarkers, and circulating antioxidant vitamins were assessed. The main outcome was a significantly higher advanced lung cancer inflammation index (ALI) in patients of the control arm than those following MD (p = 0.003). In the MD group, platelets were significantly reduced at the study endpoint (p = 0.044). BMI and body fat mass remained unchanged in both arms, but serum glucose was significantly higher in control compared to MD group (p = 0.017). In conclusion, we showed for the first time that implementing a personalised MD for 3 months is promising to regulate prognostic biomarkers in advanced LC. The final results of our on-going trial will shed a light on the inflammatory, antioxidant and nutritional status of LC patients following MD.

Application of Clinical Decision Support System to Assist Breast Cancer Patients with Lifestyle Modifications during the COVID-19 Pandemic: A Randomised Controlled Trial

“…The daily amount of fiber consumption accounted for 20–30 g. Other health issues such as constipation, diarrhoea or gastro-esophageal reflux were also assessed by the CDSS for the formulation of the dietetic scheme. Furthermore, the dieticians provided nutritional consultation on MD [ 32 ]. Patients were trained to use the CDSS and received individual login passwords allowing access to their personal profile from home.…”

“…Anthropometric measurements: The BOD POD, an air displacement plethysmography device (BOD POD® Body Composition Tracking Systems, Life Measurement, Inc., Rome, Italy), was applied to measure body weight (BW) and body fat mass (BFM) as has been previously described [ 32 ]. Patients’ height was recorded to the nearest millimeter using a standard stadiometer.…”

“…Quantification of serum 1,25-dihydroxyvitamin D [1,25(OH)2D] involved an automated chemiluminescence system (Cobas e 801 analytical module, Roche Diagnostics GmbH, Mannheim, Germany) and deficiency was defined as circulating 1,25(OH)2D < 18 pg/mL [ 40 ]. Levels of plasma ascorbic acid (vitamin C) were measured by reversed-phase high performance liquid chromatography (HPLC), as has been previously described [ 32 ]. Concentration less than 1.94 mg/L determined vitamin C deficiency [ 41 ].…”

The Effects of a Mediterranean Diet Intervention on Cancer-Related Fatigue for Patients undergoing Chemotherapy: A Pilot Randomized Controlled Trial

“…Our data add to the growing body of literature that a MedDiet intervention is safe and feasible during active cancer treatment. Mediterranean-inspired diets have been conducted with success in other randomized controlled trials among patients undergoing chemotherapy including patients with lung cancer (inclusion criteria included patients on other active treatments as well) [44], breast cancer [45], and acute myeloid leukemia [46]. Gioxari et al [44] administered a resource-intensive 3-month intervention with personalized nutritional counseling, daily diet plans, and educational booklets, delivered by experienced dietitians.…”

“…Mediterranean-inspired diets have been conducted with success in other randomized controlled trials among patients undergoing chemotherapy including patients with lung cancer (inclusion criteria included patients on other active treatments as well) [44], breast cancer [45], and acute myeloid leukemia [46]. Gioxari et al [44] administered a resource-intensive 3-month intervention with personalized nutritional counseling, daily diet plans, and educational booklets, delivered by experienced dietitians. They used a different MedDiet score than used herein, and observed a 5.5-point increase in score in the MedDiet group (n=12) compared to a 1.5-point increase in the control group (n=12, p=0.031).…”