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1.
Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors.
Natalucci, V, Ferri Marini, C, De Santi, M, Annibalini, G, Lucertini, F, Vallorani, L, Panico, AR, Sisti, D, Saltarelli, R, Donati Zeppa, S, et al
Trials. 2023;(1):134
Abstract
BACKGROUND Breast cancer (BC) is the most common invasive cancer in women, and exercise can significantly improve the outcomes of BC survivors. MoviS (Movement and Health Beyond Care) is a randomized controlled trial aimed to evaluate the potential health benefits of exercise and proper nutritional habits. This study aims to assess the efficacy of aerobic exercise training in improving quality of life (QoL) and health-related factors in high-risk BC. METHODS One hundred seventy-two BC survivor women, aged 30-70 years, non-metastatic, stage 0-III, non-physically active, 6-12 months post-surgery, and post chemo- or radiotherapy, will be recruited in this study. Women will be randomly allocated to the intervention arm (lifestyle recommendations and MoviS Training) or control arm (lifestyle recommendations). The MoviS training consists of 12 weeks of aerobic exercise training (2 days/week of supervised and 1 day/week of unsupervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min). Both arms will receive counseling on healthy lifestyle habits (nutrition and exercise) based on the World Cancer Research Fund International (WCRF) 2018 guidelines. The primary outcome is the improvement of the QoL. The secondary outcomes are improvement of health-related parameters such as Mediterranean diet adherence, physical activity level, flexibility, muscular fitness, fatigue, cardiorespiratory fitness (estimated maximal oxygen uptake), echocardiographic parameters, heart rate variability (average of the standard deviations of all 5 min normal to normal intervals (ASDNN/5 min) and 24 h very low and low frequency), and metabolic, endocrine, and inflammatory serum biomarkers (glycemia, insulin resistance, progesterone, testosterone, and high-sensitivity C-reactive protein). DISCUSSION This trial aims to evaluate if supervised exercise may improve QoL and health-related factors of BC survivors with a high risk of recurrence. Findings from this project could provide knowledge improvement in the field of exercise oncology through the participation of a multidisciplinary team that will provide a coordinated program of cancer care to improve healthcare quality, improve prognosis, increase survival times and QoL, and reduce the risk of BC recurrence. TRIAL REGISTRATION ClinicalTrials.gov NCT04818359 . Retrospectively registered on March 26, 2021.
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2.
A proposal for the reference intervals of the Italian microbiota "scaffold" in healthy adults.
Sisti, D, Pazienza, V, Piccini, F, Citterio, B, Baffone, W, Donati Zeppa, S, Biavasco, F, Prospero, E, De Luca, A, Artico, M, et al
Scientific reports. 2022;(1):3952
Abstract
Numerous factors, ranging from genetics, age, lifestyle, and dietary habits to local environments, contribute to the heterogeneity of the microbiota in humans. Understanding the variability of a "healthy microbiota" is a major challenge in scientific research. The gut microbiota profiles of 148 healthy Italian volunteers were examined by 16S rRNA gene sequencing to determine the range and diversity of taxonomic compositions in the gut microbiota of healthy populations. Possible driving factors were evaluated through a detailed anamnestic questionnaire. Microbiota reference intervals were also calculated. A "scaffold" of a healthy Italian gut microbiota composition was identified. Differences in relative quantitative ratios of microbiota composition were detected in two clusters: a bigger cluster (C2), which included 124 subjects, was characterized by more people from the northern Italian regions, who habitually practised more physical activity and with fewer dietary restrictions. Species richness and diversity were significantly higher in this cluster (C2) than in the other one (C1) (C1: 146.67 ± 43.67; C2: 198.17 ± 48.47; F = 23.40; P < 0.001 and C1: 16.88 ± 8.66; C2: 35.01 ± 13.40; F = 40.50; P < 0.001, respectively). The main contribution of the present study was the identification of the existence of a primary healthy microbiological framework that is only marginally affected by variations. Taken together, our data help to contextualize studies on population-specific variations, including marginal aspects, in human microbiota composition. Such variations must be related to the primary framework of a healthy microbiota and providing this perspective could help scientists to better design experimental plans and develop strategies for precision tailored microbiota modulation.
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3.
Clinical impact of first-line bevacizumab plus chemotherapy in metastatic colorectal cancer of mucinous histology: a multicenter, retrospective analysis on 685 patients.
Catalano, V, Bergamo, F, Cremolini, C, Vincenzi, B, Negri, F, Giordani, P, Alessandroni, P, Intini, R, Stragliotto, S, Rossini, D, et al
Journal of cancer research and clinical oncology. 2020;(2):493-501
Abstract
PURPOSE In metastatic colorectal cancer (MCRC), mucinous histology has been associated with poor response rate and prognosis. We investigated whether bevacizumab combined with different chemotherapy regimens may have an impact on clinical outcomes of MCRC patients with mucinous histology. METHODS 685 MCRC patients were classified in mucinous adenocarcinoma (MC) and non-mucinous adenocarcinoma (NMC) and were treated with first-line bevacizumab plus fluoropyrimidine (FP)-based, oxaliplatin (OXA)-based, irinotecan (IRI)-based, or FOLFOXIRI. RESULTS Ninety-four (13.7%) patients had MC. With a median follow-up of 50 months, MC patients had a median overall survival (OS) of 28.2 months compared with 27.7 months for the NMC group [hazard ratio (HR) = 0.92; 95% confidence interval (CI) 0.70-1.19, P = 0.530]. The overall response rates for MC and NMC were 41.5% (95% CI 31.5-51.4) and 62.4% (95% CI 58.4-66.3), respectively (Chi-square test, P <0.003). After correcting for significant prognostic factors by multivariate Cox regression analysis, age, resection of the primary tumour, and number of metastatic sites were found to be associated with poorer OS, but not mucinous histology. CONCLUSION Compared with NMC, MCRC patients with mucinous histology treated with bevacizumab plus chemotherapy had comparable OS despite lower overall response rate.
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4.
High-intensity Interval Training Promotes the Shift to a Health-Supporting Dietary Pattern in Young Adults.
Donati Zeppa, S, Sisti, D, Amatori, S, Gervasi, M, Agostini, D, Piccoli, G, Bertuccioli, A, Rocchi, MBL, Stocchi, V, Sestili, P
Nutrients. 2020;(3)
Abstract
A healthy lifestyle is based on a correct diet and regular exercise. Little is known about the effect of different types of exercise on dietary preferences. To address the question of whether high-intensity interval training (HIIT) could modulate spontaneous food choices, an experimental study was carried out on 32 young, healthy normal-weight subjects. The spontaneous diet of each subject has been monitored over nine weeks of indoor-cycling training, divided into three mesocycles with an incremental pattern: total energy intake, macronutrients and micronutrients have been analysed. A two-way mixed model has been used to assess differences in dietary variables; a principal factor analysis has been performed to identify sample subgroups. An increased energy intake (+17.8% at T3; p < 0.01) has been observed, although macronutrients' proportions did not vary over time, without differences between sexes. An increase of free fat mass was found in the last mesocycle (+3.8%), without an augmentation of body weight, when, despite the increased training load, a stabilization of energy intake occurred. Three different subgroups characterized by different dietary modifications could be identified among participants that showed a common trend towards a healthier diet. Nine weeks of HIIT promoted a spontaneous modulation of food choices and regulation of dietary intake in young normal-weight subjects aged 21-24. Importantly, this life-period is critical to lay the foundation of correct lifestyles to prevent metabolic diseases and secure a healthy future with advancing age.
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MicroRNAs Bioinformatics Analyses Identifying HDAC Pathway as a Putative Target for Existing Anti-COVID-19 Therapeutics.
Teodori, L, Sestili, P, Madiai, V, Coppari, S, Fraternale, D, Rocchi, MBL, Ramakrishna, S, Albertini, MC
Frontiers in pharmacology. 2020;:582003
Abstract
Over 313,000 SARS-CoV-2 positive cases have been confirmed in Italy as of 30 September 2020, and the number of deaths exceeding thirty-five thousand makes Italy among the list of most significantly affected countries in the world. Such an enormous occurrence of infections and death raises the urgent demand for effective available treatments. Discovering the cellular/molecular mechanisms of SARS-CoV-2 pathogenicity is of paramount importance to understand how the infection becomes a disease and how to plan any therapeutic approach. In this regard, we performed an in silico analysis to predict the putative virus targets and evidence the already available therapeutics. Literature experimental results identified angiotensin-converting enzyme ACE and Spike proteins particularly involved in COVID-19. Consequently, we investigated the signalling pathways modulated by the two proteins through query miRNet, the platform linking miRNAs, targets, and functions. Our bioinformatics analysis predicted microRNAs (miRs), miR-335-5p and miR-26b-5p, as being modulated by Spike and ACE together with histone deacetylate (HDAC) pathway. Notably, our results identified ACE/ACE2-ATR1-Cholesterol-HDAC axis signals that also matched with some available clinical data. We hypothesize that the current and EMA-approved, SARS-CoV-2 off-label HDAC inhibitors (HDACis) drugs may be repurposed to limit or block host-virus interactions. Moreover, a ranked list of compounds is provided for further evaluation for safety, efficacy, and effectiveness.
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Effects of a commercially available branched-chain amino acid-alanine-carbohydrate-based sports supplement on perceived exertion and performance in high intensity endurance cycling tests.
Gervasi, M, Sisti, D, Amatori, S, Donati Zeppa, S, Annibalini, G, Piccoli, G, Vallorani, L, Benelli, P, Rocchi, MBL, Barbieri, E, et al
Journal of the International Society of Sports Nutrition. 2020;(1):6
Abstract
BACKGROUND Sports nutritional supplements containing branched-chain amino acids (BCAA) have been widely reported to improve psychological and biological aspects connected to central fatigue and performance in endurance exercise, although the topic is still open to debate. The aim of the present study was to determine whether the intake of a commercially available BCAA-based supplement, taken according to the manufacturer's recommendations, could affect the rating of perceived exertion (RPE) and performance indexes at the beginning (1d) and end of a 9-week (9w) scheduled high intensity interval training program, with an experimental approach integrating the determination of psychometric, performance, metabolic and blood biochemical parameters. METHODS This was a randomized double-blind placebo-controlled study. Thirty-two untrained, healthy young adults (20 males and 12 female) were enrolled. A high-intensity endurance cycling (HIEC) test was used to induce fatigue in the participants: HIEC consisted in ten 90 s sprints interspersed by ten 3 min recovery phases and followed by a final step time to exhaustion was used. In parallel with RPE, haematological values (creatine kinase, alanine, BCAA, tryptophan, ammonia and glucose levels), and performance indexes (maximal oxygen consumption - VO2max, power associated with lactate thresholds - WLT1, WLT2 and time to exhaustion - TTE) were assessed. All subject took the supplement (13.2 g of carbohydrates; 3.2 g of BCAA and 1.6 g of L-alanine per dose) or placebo before each test and training session. Dietary habits and training load were monitored during the entire training period. RESULTS The administration of the supplement (SU) at 1d reduced RPE by 9% during the recovery phase, as compared to the placebo (PL); at 9w the RPE scores were reduced by 13 and 21% during the sprint and recovery phase, respectively; at 9w, prolonged supplement intake also improved TTE and TRIMP. SU intake invariably promoted a rapid increase (within 1 h) of BCAA serum blood levels and prevented the post-HIEC tryptophan: BCAA ratio increase found in the PL group, at both 1d and 9w. There was no difference in dietary habits between groups and those habits did not change over time; no difference in glycemia was found between SU and PL. VO2max, WLT1 and WLT2 values improved over time, but were unaffected by supplement intake. CONCLUSIONS On the whole, these results suggest that i) the intake of the BCAA-based commercially available supplement used in this study reduces RPE as a likely consequence of an improvement in the serum tryptophan: BCAA ratio; ii) over time, reduced RPE allows subjects to sustain higher workloads, leading to increased TRIMP and TTE.
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Half-life of plasma phytosterols in very low birth weight preterm infants on routine parenteral nutrition with vegetable oil-based lipid emulsions.
Pupillo, D, Correani, A, Biagetti, C, D'Ascenzo, R, Simonato, M, Verlato, G, Cogo, P, Rocchi, MBL, Carnielli, VP
Clinical nutrition (Edinburgh, Scotland). 2018;(1):262-269
Abstract
BACKGROUND Phytosterols in vegetable oil (VO)-based lipid emulsions (LE) likely contribute to parenteral nutrition-associated cholestasis (PNAC) in preterm infants. No characterization of plasma phytosterol half-lives has been done in very low birth weight (VLBW) preterm infants receiving parenteral nutrition (PN) with LE. METHODS In a prospective cohort study, 45 VLBW preterm infants who received PN underwent serial blood sample measurements of sitosterol (SITO), campesterol (CAMP), and stigmasterol (STIGM). Plasma phytosterol half-lives were calculated from the phytosterol concentrations-decay curves by using a single-compartment model. RESULTS After the stop of the intravenous LE, study infants had significantly lower plasma total CAMP, STIGM and SITO concentrations. The decay of plasma phytosterol concentrations was monoexponential. Half-life of plasma total CAMP, STIGM and SITO was 13.5 ± 6.9, 10.3 ± 4.5 and 10.3 ± 4.0 days, respectively. Plasma phytosterol half-lives did not correlate with gestational age, birth weight, cumulative phytosterol intakes and plasma conjugated bilirubin. CONCLUSION VLBW preterm infants on PN with LE had rather long plasma phytosterol half-lives similar to hypercholesterolemic adults and phytosterolemic homozygotes patients. We speculate that the accumulation of phytosterols could contribute to their vulnerability to PNAC. CLINICAL TRIAL REGISTRY The Ethics Committee of Marche-Italy (DG/469); www.clinicaltrials.gov (identification number NCT02758834).
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Plasma Phytosterol Half-Life and Levels Are Increased in Very Low Birth Weight Preterm Infants with Parenteral Nutrition-Associated Cholestasis.
Correani, A, Pignotti, A, Marinelli, L, Biagetti, C, D'Ascenzo, R, Vedovelli, L, Verlato, G, Cogo, P, Rocchi, MBL, Carnielli, VP
Lipids. 2018;(7):717-725
Abstract
Parenteral nutrition-associated cholestasis (PNAC) has been linked to plasma accumulation of phytosterols in infants receiving vegetable-oil-based lipid emulsions (LE). To date, information on the ability of infants with PNAC to metabolize intravenous (IV) phytosterols has been very limited. We characterized plasma phytosterol half-life in very low birth weight (VLBW) preterm infants with PNAC. As part of a prospective cohort study, VLBW infants with PNAC underwent serial blood sample measurements of sitosterol (Sito), campesterol (Camp), and stigmasterol (Stigma). Infants without PNAC served as controls (CTRL, control infants). Thirty-seven PNAC infants and 14 CTRL were studied. On PN day 7 and PN day 14, PNAC infants had higher plasma phytosterol concentrations compared to those of CTRL (p < 0.05). A significant and positive correlation was found between plasma Camp, Stigma, Sito concentrations, and IV phytosterol intake from birth to PN day 7 (p = 0.001, p = 0.001, and p = 0.005, respectively). Stigma concentration was positively correlated with conjugated bilirubin on PN day 7 (p = 0.012). After stopping IV LE, half-lives of Camp, Stigma, and Sito became significantly longer in PNAC infants than in CTRL (Camp: 18.8 ±6.2 vs 11.8 ±3.0 days, p = 0.001; Stigma: 13.8 ±5.8 vs 9.4 ±3.4 days, p = 0.023; Sito: 15.3 ±5.0 vs 9.8 ±3.0 days, p = 0.002). In conclusion, phytosterols increased earlier during PN and were eliminated slowly after stopping IV LE in PNAC infants than in CTRL. The Stigma concentration on PN day 7 could represent an early marker of cholestasis. Our results provide additional evidence on the relationship between IV phytosterols and PNAC.
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The Effect of Experimental Supplementation with the Klamath Algae Extract Klamin on Attention-Deficit/Hyperactivity Disorder.
Cremonte, M, Sisti, D, Maraucci, I, Giribone, S, Colombo, E, Rocchi, MBL, Scoglio, S
Journal of medicinal food. 2017;(12):1233-1239
Abstract
Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurobiological condition with onset in childhood. The disorder is characterized by inattention, impulsivity, and/or motor hyperactivity, which often affect the development and social integration of affected subjects. Phenylethylamine (PEA), naturally contained in the Klamath Lake microalgae and concentrated in the Klamin® extract, is an endogenous molecule with a general neuromodulatory activity. It functions as an activator for the neurotransmission of dopamine and other catecholamines, and very low concentrations of PEA may be associated with specific psychological disorders such as ADHD. The aim of our study was to evaluate the efficacy of the Klamin extract in treating a group of subjects diagnosed with ADHD. Thirty subjects, aged 6-15, who had been diagnosed with ADHD according to the DSM-IV TR criteria, were enrolled. The supplement was administered to all the subjects, who reported to an ADHD clinic for routine follow-up visits. Observations were made and data collected over a 6-month period. After 6 months of therapy the subjects appeared to show significant improvements based on assessments of their overall functioning, behavioral aspects related to inattention and hyperactivity-impulsivity, attention functions in both the selective and sustained component and executive functions. The study appears to confirm the initial hypothesis that the Klamin extract may positively affect the expression of ADHD symptoms. Additional larger studies on the effects of Klamin on ADHD are needed to further investigate the potential of this extract in ADHD treatment.
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The effect of topical thiocolchicoside in preventing and reducing the increase of muscle tone, stiffness, and soreness: A real-life study on top-level road cyclists during stage competition.
Gervasi, M, Sisti, D, Benelli, P, Fernández-Peña, E, Calcabrini, C, Rocchi, MBL, Lanata, L, Bagnasco, M, Tonti, A, Vilberto, S, et al
Medicine. 2017;(30):e7659
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Abstract
In professional road cyclists, the majority of overuse injuries affect the lower limbs and are mostly represented by contractures or muscle shortening, characterized by an increase of tone and stiffness and a variation of elasticity. Treatment and prevention of these specific conditions may include physical, supplementary, and pharmacologic support. The aim of this real-life study was to determine: first, the alterations of tone, stiffness, elasticity, and soreness of rectus femoris (RF) and biceps femoris (BF) in top class cyclists engaged in 3 multistage races, and second, whether any variable in the management of the athletes may affect the prevention and/or reduction of such alterations.Twenty-three professional cyclists competing in 3 international, cycling stage races were assessed. Athletes could receive, upon the approval of the medical staff, physical, dietary, and/or pharmacological management which could include treatments with topical over-the-counter myorelaxants to prevent and/or reduce muscle contractures. MyotonPro was used to daily measure tone, stiffness, and elasticity in RF and BF in relaxed and contracted state after every stage. In parallel, BF and RF soreness was also assessed with a Likert scale.All athletes received the same general massage management; none of them received dietary supplements; some of the athletes were treated with a topical myorelaxant thiocolchicoside (TCC 0.25%) foam 3 times daily. TCC was identified as the only variable able to affect these muscle parameters in the cyclists. Tone, stiffness (regardless of the state), and soreness significantly increased over time either in BF or RF in all athletes. In the group of athletes that used TCC (n = 11; TCC+) the increase in tone, stiffness, and soreness was significantly lower than in the group not receiving TCC (n = 12; No-TCC). Elasticity varied coherently with tone and stiffness.A very intense and protracted sport activity increases muscular tone, stiffness, and soreness over time. Topical TCC foam significantly attenuates these alterations and might represent an efficient strategy both to prevent and manage contractures and their consequences in professional cyclists as well in athletes from other disciplines involving similar workloads.