Optimizing Dietary Habits in Adolescents with Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention via Clinical Decision Support System-A Randomized Controlled Trial.

The hypothesis of this randomized controlled trial was that a clinical decision support system (CDSS) would increase adherence to the Mediterranean diet (MD) among adolescent females with polycystic ovary syndrome (PCOS). The objective was to assess the impact of personalized MD plans delivered via a CDSS on nutritional status and psychological well-being. Forty adolescent females (15-17 years) with PCOS were randomly assigned to the MD group (n = 20) or the Control group (n = 20). The MD group received personalized MD plans every 15 days via a CDSS, while the Control group received general nutritional advice. Assessments were conducted at baseline and after 3 months. Results showed significantly increased MD adherence in the MD group compared to the Control group (p < 0.001). The MD group exhibited lower intakes of energy, total fat, saturated fat, and cholesterol, and higher intakes of monounsaturated fat and fiber (p < 0.05). Serum calcium and vitamin D status (p < 0.05), as well as anxiety (p < 0.05) were improved. In conclusion, tailored dietary interventions based on MD principles, delivered via a CDSS, effectively manage PCOS in adolescent females. These findings highlight the potential benefits of using technology to promote dietary adherence and improve health outcomes in this population. ClinicalTrials.gov registry: NCT06380010.

Association of Serum Calcium Levels of Preterm Neonates at Birth with Calcium Intake from Foods and Supplements by Bedridden Women during Pregnancy.

Bone calcium turnover is aggravated in pregnant women recommended to bed rest. In the present cross-sectional study, we aimed to clarify whether preterm neonates would benefit from calcium supplementation during pregnancy. Forty-two mothers (37.5 ± 6.7 years), recommended bed rest at home, and 42 preterm neonates (24-37 weeks gestational age) were enrolled. Neonates' serum calcium was quantified at birth. Mothers' calcium intake from foods and supplements during pregnancy was assessed. Serum 25-OH-D was measured in both mothers and neonates at birth. Results showed that mothers' calcium intake from foods was significantly lower than the recommended daily reference value (p < 0.001), while total calcium intake including supplements was close to the calcium reference value of 1000 mg/day (p = 0.648). Neonates' serum calcium concentration was significantly higher in mothers receiving calcium supplementation during pregnancy compared to mothers who did not (p < 0.001). A significant association between neonates' serum calcium levels and mothers' calcium supplementation was evident, even when adjusted to mothers' age, pre-pregnancy BMI, gestational age, and neonates' birth weight (beta = +0.460, p = 0.025). A statistically significant correlation between neonates' and mothers' serum 25-OH-D levels was found (r = 0.891, p < 0.001). In conclusion, calcium status in preterm neonates, born by bedridden women, could be enhanced after calcium supplementation during gestation.

The Effect of Melatonin Supplementation on Cancer-Related Fatigue during Chemotherapy Treatment of Breast Cancer Patients: A Double-Blind, Randomized Controlled Study.

Cancer-related fatigue (CRF) is a common distressing complaint of breast cancer (BC) patients treated with chemotherapy. Nutritional quality plays a pivotal role in CRF, while increased interest towards new pharmacological agents has been observed. Melatonin, an endogenous hormone that regulates the human sleep-wake cycle, could alleviate CRF. In the present randomized, placebo-controlled 3-month trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo in BC patients on CRF. In both arms, the Mediterranean diet (MD) was implemented. Medical history, anthropometry and blood withdrawal were performed. CRF was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire and MD adherence by the MedDietScore. In total, 49 BC women (median age 52 years) were recruited, namely N = 23 in the intervention arm and N = 26 in the placebo arm. At baseline, CRF was positively associated with body mass index (BMI), even when adjusted for age, waist circumference and blood indices related to disease prognosis (beta = -0.882, p = 0.003). At 3 months, both groups showed a BMI decrease (p < 0.05), but only the intervention group improved CRF compared to baseline (p = 0.003). No differences in CRF were observed between the groups. In conclusion, melatonin oral supplementation could ameliorate CRF in BC patients.

Mediterranean Diet and Physical Activity Nudges versus Usual Care in Women with Rheumatoid Arthritis: Results from the MADEIRA Randomized Controlled Trial.

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.

Improving Adherence to the Mediterranean Diet in Early Pregnancy Using a Clinical Decision Support System; A Randomised Controlled Clinical Trial.

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.

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

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.

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

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.

Does a parenteral nutrition decision support system for total nutrients improve prescription procedure and neonatal growth?

Background and objectives: Parenteral nutrition (PN) is an integral part of the nutritional support of critically ill neonates in the intensive care units (ICU). The evaluation of a decision support system for total nutrients (DSSFTN) is of great importance for clinical practice. This study's aim was to evaluate the impact caused by implementation of a DSSFTN on PN support and neonatal growth. This pilot work was supported by the hospital PN team (PNT) in order to assess possible benefits stemming from the use of DSSFTN.Materials and methods: DSSFTN development is based on the incorporation of pharmaceutical and therapeutic protocols. Thirty-eight neonates were recruited. Inclusion criteria included: patients should (a) be hospitalized in ICU, (b) receive PN support at least for 15 days, (c) have birth weight 550-1600 g. One exclusion criterion was applied: patients should have no inborn error of metabolism. 15 doctors prescribed PN for two groups of neonates. PN was calculated by doctors for Group 1 (19 neonates) and respectively was calculated by the DSSFTN (and checked by doctors) for Group 2 (19 neonates). A questionnaire was completed later by doctors to evaluate DSSFTN.Results: The implementation of DSSFTN led to appropriate composition and administration of PN. Growth was not significantly different between the study groups. Compliance with guidelines was observed. DSSFTN ameliorated intercommunication among doctors.Conclusions: The implementation of DSSFTN enables health professionals to facilitate the complex task of prescribing. It ensures the consistency of PN prescriptions, as it leads to appropriate dosing in all nutrients. DSSFTN provides real-time PN interventions (clinical conditions and enteral amounts are included additionally) and minimizes exposure to human errors.

Administration of an Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids is Beneficial Towards Anti-Inflammatory Related Fatty Acid Profile in Preterm Neonates: A Randomized, Double-Blind Clinical Trial.

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.

Early Postnatal Changes of Bone Turnover Biomarkers in Very Low-Birth-Weight Neonates-The Effect of Two Parenteral Lipid Emulsions with Different Polyunsaturated Fatty Acid Content: A Randomized Double-Blind Study.

BACKGROUND: ω-3 polyunsaturated fatty acids (n-3 PUFAs) are reported to have beneficial effect on bone mineral density. This study aimed to evaluate early changes of bone turnover biomarkers in very low-birth-weight (VLBW) neonates and the effect of 2 parenteral lipid emulsions (PLEs) with different PUFA composition. METHODS: This is a randomized double-blind study with parallel design. VLBW neonates (n = 66) receiving parenteral nutrition (PN)>70% of daily energy requirements for >14 days were assigned into 2 groups that were prescribed soybean oil-based (n = 35) and n-3-enriched PLE (n = 31), respectively. Osteoprotegerin (OPG), soluble receptor activator of nuclear factor-kB ligand (sRANKL), osteocalcin (OC), interleukin-6 (enzyme-linked immunoblot assay kits), Ca, and P plasma levels were assessed before PLE implementation (T1) and on day 20 of life (T2). RESULTS: In the total population, sRANKL and OC significantly increased, whereas OPG and the OPG/sRANKL ratio decreased from T1 to T2. Within each group, T1-to-T2 changes of OC were significant in both groups, whereas those of OPG/sRANKL were significant only in the soybean-based group. Multiple regressions showed an independent effect of group allocation on OPG change. Significant associations were observed between PN duration and sRANKL change (negatively), n-6/n-3 and OC changes (positively), and OPG and sRANKL changes (positively). CONCLUSIONS: A high bone-turnover rate in VLBW neonates with predominance of bone resorption is confirmed. The lower rate of OPG/sRANKL reduction in the n-3-enriched PLE group indicates that n-3 PUFA-enriched PLEs may help to attenuate early bone loss in VLBW neonates.

Nutrition-drug interactions: a Web-based approach to pharmaceutical care in Greece.

OBJECTIVES: To evaluate Greek pharmacists' willingness to use a new Web-based software program to detect drug-food interactions, to assess the experience of those pharmacists opting to use the program, and to estimate the public benefit associated with use of the program. PRACTICE INNOVATION AND RESULTS: The Nutrition-Drug Interaction program was developed to enable Greek pharmacists to access an online database of medication-related information, including detailed drug and pharmaceutical company listings, nutritional guidelines for patients, potential drug-food and drug-drug interactions, and reaction alerts. More than 50% of the community pharmacists agreeing to use the program found it "quite useful" or "very useful," with more than 62% saying they were "very satisfied" or "quite satisfied" with the quality of information provided through the program. CONCLUSION: A significant proportion of Greek pharmacists, especially those 50 years of age or younger, found a new Web-based drug-food interaction software program to be both informative and useful. Participating pharmacists reported that use of the new program enhanced their role as health consultants and helped improve the quality of the patient services they provide.