Clinical decision support systems (CDSS) are data aggregation tools based on computer technology that assist clinicians to promote healthy weight management and prevention of cardiovascular diseases. We carried out a randomised controlled 3-month trial to implement lifestyle modifications in breast cancer (BC) patients by means of CDSS during the COVID-19 pandemic. In total, 55 BC women at stages I-IIIA were enrolled. They were randomly assigned either to Control group, receiving general lifestyle advice (n = 28) or the CDSS group (n = 27), to whom the CDSS provided personalised dietary plans based on the Mediterranean diet (MD) together with physical activity guidelines. Food data, anthropometry, blood markers and quality of life were evaluated. At 3 months, higher adherence to MD was recorded in the CDSS group, accompanied by lower body weight (kg) and body fat mass percentage compared to control (p < 0.001). In the CDSS arm, global health/quality of life was significantly improved at the trial endpoint (p < 0.05). Fasting blood glucose and lipid levels (i.e., cholesterol, LDL, triacylglycerols) of the CDSS arm remained unchanged (p > 0.05) but were elevated in the control arm at 3 months (p < 0.05). In conclusion, CDSS could be a promising tool to assist BC patients with lifestyle modifications during the COVID-19 pandemic.
This randomized dietary intervention based on MD managed to ameliorate serum antioxidant capacity, body composition, adherence to MD and glycemic profile of postmenopausal BC survivors.
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.
Prenatal health is important for both mother and child. Additionally, the offspring’s development is affected by the mother’s diet. The aim of this study was to assess whether a Clinical Decision Support System (CDSS) can improve adherence to the Mediterranean diet in early pregnancy and whether this change is accompanied by changes in nutritional status and psychological parameters. We designed a three month randomised controlled clinical trial which was applied to 40 healthy pregnant women (20 in the CDSS and 20 in the control group). Medical history, biochemical, anthropometric measurements, dietary, and a psychological distress assessment were applied before and at the end of the intervention. Pregnant women in the CDSS group experienced a greater increase in adherence to the Mediterranean diet, as assessed via MedDietScore, in the first trimester of their pregnancy compared to women in the control group (p < 0.01). Furthermore, an improved nutritional status was observed in pregnant women who were supported by CDSS. Anxiety and depression levels showed a greater reduction in the CDSS group compared to the control group (p = 0.048). In conclusion, support by a CDSS during the first trimester of pregnancy may be beneficial for the nutritional status of the mother, as well as for her anxiety and depression status.
Background: Multiple sclerosis (MS) is a chronic immune-mediated central nervous system disorder that affects females twice as often as males. MS patients show increased susceptibility to obesity and related cardiometabolic disorders, while diet may influence disease course. In the present randomized controlled study, we aimed to increase Mediterranean Diet (MedDiet) adherence in MS women and improve their nutritional status. Methods: Adult women with relapsing-remitting MS (n = 40) were randomly allocated to intervention (n = 20) or control group (n = 20). Individual dietary plans based on MedDiet together with nutritional consultation were provided to the intervention group. Controls received general lifestyle advice according to “National Dietary Guidelines”. Medical history, anthropometry, dietary records, and blood withdrawal were performed at baseline and at 3 months. Results: Compared to controls, the intervention group demonstrated greater MedDiet adherence (p < 0.001), which was negatively associated with cholesterol intake levels (p < 0.05). At 3 months, women following MedDiet had ameliorated body weight and body composition compared to baseline (p < 0.001). Serum 1,25(OH)2D was significantly higher in both study groups at 3 months (p < 0.001), but in the intervention group, the mean increment was twofold compared to controls (p < 0.001). Conclusion: Personalized nutritional intervention in MS patients may improve MedDiet adherence and nutritional status towards cardioprotective health outcomes.
Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. We aimed to investigate the effects of a medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile and serum interleukin-6 (IL-6) in preterm neonates. In this double-blind randomized study, 92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g) were assigned to receive either MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry. Serum IL-6 was measured with sandwich ELISA in 59 neonates. Plasma FAs changed significantly over time; the MCT/ω-3 PUFA-IVFE group showed higher ω-3 PUFAs (p = 0.031), eicosapentaenoic acid (p = 0.000), and oleic acid (p = 0.003), and lower ω-6/ω-3 PUFAs ratio (p = 0.001) and ω-6 PUFAs (p = 0.023) compared to control group. Linoleic acid was higher in the soybean oil (SO)-based IVFE arm compared to the MCT/ω-3 PUFAs-IVFE arm (p = 0.006). Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups. Administration of MCT/ω-3 PUFA-enriched IVFE in preterm neonates is beneficial in changing the FA profile consistent with attenuated inflammatory response.
In rheumatoid arthritis (RA), diet quality and nutritional status have been shown to impact the disease activity and adherence to the Mediterranean diet (MD) has been suggested as an anti-inflammatory regime to improve disease status and reduce cardiovascular risk. The Mediterranean DiEt In Rheumatoid Arthritis (MADEIRA) was a single-blind (statistician), two-arm randomized clinical trial, investigating the effects of a 12-week lifestyle intervention, including a personalized isocaloric MD plan with the promotion of physical activity (PA), supported through a clinical decision support systems (CDSS) platform, versus usual care in women with RA. Forty adult women with RA on remission were randomly allocated (1:1 ratio) to either the intervention or the control arm. The intervention group received personalized MD plans and lifestyle consultation on improving PA levels, whereas the controls were given generic dietary and PA advice, based on the National Dietary Guidelines. The primary outcome was that the difference in the MD adherence and secondary outcomes included change in disease activity (DAS28), anthropometric indices (BodPod), dietary intake, PA, vitamin D concentrations, and blood lipid profiles after 12 weeks from the initiation of the trial. At 3 months post-baseline, participants in the MD arm exhibited greater adherence to the MD compared with the controls (p < 0.001), lower DAS28 (p < 0.001), favorable improvements in dietary intake (p = 0.001), PA (p = 0.002), body weight and body composition (p < 0.001), blood glucose (p = 0.005), and serum 1,25(OH)2D concentrations (p < 0.001). The delivery of the MD and PA promotion through CDSS nudges in women with RA in an intensive manner improves the MD adherence and is associated with beneficial results regarding disease activity and cardiometabolic-related outcomes, compared with the usual care.
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