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Effects of a chronotype-adapted diet on weight loss, cardiometabolic health, and gut microbiota: study protocol for a randomized controlled trial.
Dinu, M, Lotti, S, Pagliai, G, Napoletano, A, Asensi, MT, Giangrandi, I, Marcucci, R, Amedei, A, Colombini, B, Sofi, F
Trials. 2024;(1):152
Abstract
BACKGROUND Obesity and its associated health complications have become a global public health concern, necessitating innovative approaches to weight management. One emerging area of research focuses on the influence of chronotype, an individual's preferred timing for daily activities, on eating habits, weight regulation, and metabolic health. Recent observational studies suggest that the misalignment between an individual's chronotype and external cues, such as meal timing, may contribute to metabolic dysregulation and obesity, but evidence from intervention studies is still limited. This study protocol describes a randomized controlled trial designed to explore the effects of a chronotype-adapted diet, compared with a diet with a conventional calorie distribution, on weight loss, cardiometabolic health, and gut microbiota composition. METHODS A total of 150 overweight/obese adults will be recruited for this 4-month parallel-group, randomized, two-arm, open-label, superiority trial with 1:1 allocation ratio. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a low-calorie chronotype-adapted diet with a calorie distribution adapted to the individual chronotype (morning or evening), optimizing meal timing according to their peak metabolic periods. The control group will follow a standardized low-calorie healthy eating plan without considering chronotype. Both diets will have equivalent daily calorie content, adjusted according to gender and starting weight. Anthropometric measurements, body composition, blood, and fecal samples will be obtained from each participant at the beginning and the end of the study. The primary outcome is weight change from baseline. Secondary outcomes are changes from baseline in body mass index (BMI), fat mass, lipid and glycemic profile, fecal microbiota profile, and short-chain fatty acids (SCFAs). DISCUSSION The results of this randomized controlled trial have the potential to advance our understanding of the complex interactions between chronotype, diet, body weight, and health outcomes. By providing evidence for personalized dietary interventions based on individuals' circadian preferences, this research could offer insights into personalized nutrition strategies. Such knowledge could guide the development of innovative dietary interventions to optimize the prevention and management of overweight and obesity, while also improving the risk profile of these individuals. TRIAL REGISTRATION ClinicalTrials.gov NCT05941871. Registered on 18 May 2023.
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Quality of life and nutritional status of a group of post-operative head and neck cancer patients.
Tristan Asensi, M, Giangrandi, I, Sartini, L, Pagliai, G, Dinu, M, Lotti, S, Colombini, B, Sofi, F
Nutricion hospitalaria. 2023;(5):919-923
Abstract
Introduction: scientific evidence on the appropriate nutritional support in the treatment of post-operative head and neck cancer (HNC) patients is still limited. Objectives: our aim was to evaluate nutritional status and quality of life in HNC patients in post-operative phase with different nutritional support. Methods: fifty-four HNC patients (26 with enteral nutrition [EN] via percutaneous endoscopic gastrostomy [PEG] and 28 with oral nutrition [ON]) were included. Nutritional status was evaluated with biochemical parameters and quality of life through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Results: ON patients reported significantly (p < 0.05) lower levels of hemoglobin, lymphocytes, iron, folic acid, and vitamin D than EN patients, with greater percentage of ON patients found to be below the reference limits for hemoglobin (21.4 % vs 19.4 %), and significantly for serum iron (17.9 % vs 0 %) and vitamin D (78.6 % vs 30.8 %). Furthermore, EN patients had a better quality of life (63.8 ± 17.6) than ON (55.4 ± 20.3), although ON patients reported less symptoms related to dyspnea (-5.8 %), loss of appetite (-11.3 %) and vomiting (-23.1 %). Conclusions: these results suggest that the use of EN in post-operative HNC patients could have a positive effect on the nutritional status and quality of life of these patients. However, further research is needed to optimize the nutritional support in these patients in order to avoid malnutrition and improve their well-being.
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Adherence to the Mediterranean diet increased during the COVID-19 lockdown in Italy: results from the web-based Medi-Lite questionnaire.
Lotti, S, Dinu, M, Pagliai, G, Giangrandi, I, Colombini, B, Sofi, F
International journal of food sciences and nutrition. 2022;(5):650-656
Abstract
The aims of this study were to assess the Mediterranean Diet (MD) adherence in 2566 Italians who completed the validated Medi-Lite questionnaire during the year 2020, and to investigate the effect of COVID-19 confinement on dietary habits and MD adherence. To do this, we compared subjects (n = 389) that answered the questionnaire during the confinement occurred in Italy from March to May 2020 with subjects (n = 653) who completed the questionnaire in the same period (March-May) of the previous year (2019). From the results, a moderate level of MD adherence in the total sample emerged, and a significantly (p<.0001) increased adherence during lockdown was observed. Specifically, during confinement significantly (p < 0.05) higher consumption of vegetables (+9.4%), legumes (+13.5%) and pasta (+12.9%) emerged, while lower consumption was reported for bread (-13.4%) and meat and meat products (-15.4%). This study showed increased adherence to MD and a better-quality diet during the COVID-19 confinement in Italy.
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Effects of vegetarian versus Mediterranean diet on kidney function: Findings from the CARDIVEG study.
Dinu, M, Colombini, B, Pagliai, G, Giangrandi, I, Cesari, F, Gori, A, Giusti, B, Marcucci, R, Sofi, F
European journal of clinical investigation. 2021;(9):e13576
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Abstract
BACKGROUND The aim of the present study was to assess the effects of a lacto-ovo-vegetarian diet (VD), compared to a Mediterranean diet (MD), on kidney function in a group of subjects with medium-to-low cardiovascular risk profile. METHODS We analysed 107 subjects (82 women, 25 men; median age 52) who followed a VD (n = 54) and a MD (n = 53) for 3 months in the CARDIVEG study, a randomized, open, crossover trial that compared the effects of these 2 diets on cardiovascular disease risk. RESULTS The effect of the two diets on kidney function markers was evaluated by conducting a general linear model for repeated measurements adjusted for possible confounding factors such as age, sex, physical activity, alcohol, smoking, hypertension, LDL cholesterol, glucose and body weight change. A significant reduction in creatinine (-5.3%; P < .001), urea nitrogen levels (-9%; P = .001), blood urea nitrogen (BUN) (-8.7%; P = .001) and BUN/creatinine ratio (-5.8%; P < .001), and an increase in estimated glomerular filtration rate (eGFR) (+3.5%; P = .001) was observed during the VD period. On the contrary, no significant changes were noted in the MD group. Variations obtained in the two dietary interventions were significantly different (P < .0001) for creatinine levels, BUN/creatinine and eGFR, for which opposite trends were observed in the VD and MD groups. CONCLUSIONS In a selected group of subjects with medium-to-low cardiovascular risk profile, a 3 month VD period determined significant improvements in kidney function markers. Further trials are needed to confirm these results.
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Adherence to Mediterranean Diet Measured through Medi-Lite Score and Obesity: A Retrospective Study.
Dinu, M, Pagliai, G, Lotti, S, Giangrandi, I, Colombini, B, Sofi, F
Nutrients. 2021;(6)
Abstract
We recently developed and validated a questionnaire to measure adherence to the Mediterranean diet, called Medi-Lite. The aim of this study was to assess the accuracy of the Medi-Lite adherence score in relation to obesity status. A total of 208 patients who attended the Clinical Nutrition Unit of Careggi University Hospital, Florence, were included in this retrospective analysis. Of them, 126 (45%) had abdominal obesity (110 F; 16 M). The mean adherence score, calculated through the Medi-Lite questionnaire, was 9.5 ± 2.2, with significantly (p < 0.001) lower values in patients with abdominal obesity (8.9 ± 1.9) than those without abdominal obesity (10 ± 2.2). Logistic regression analysis adjusted for age and sex showed that the Medi-Lite score determined significant protection (-28%) against the risk of abdominal obesity for every one-unit increase in the total score (OR 0.72, 95% CI 0.63-0.82; p < 0.001). Looking for cut-off values that denote increased risk of having abdominal obesity, we observed that patients who scored ≤9 had a significantly increased risk (OR 3.21, 95% CI 1.91-5.39; p < 0.001). Adherence to the Mediterranean diet assessed through the Medi-Lite score was found to be associated with abdominal obesity. In particular, patients who reported a score of ≤9 had a 3.5-fold times higher risk of having abdominal obesity than those who scored >9.
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Effect of consumption of ancient grain bread leavened with sourdough or with baker's yeast on cardio-metabolic risk parameters: a dietary intervention trial.
Pagliai, G, Venturi, M, Dinu, M, Galli, V, Colombini, B, Giangrandi, I, Maggini, N, Sofi, F, Granchi, L
International journal of food sciences and nutrition. 2021;(3):367-374
Abstract
The aim of this study was to compare the effect of consumption of ancient grain "Verna" bread obtained by two different leavening agents, sourdough (SD) and baker's yeast (BY), on inflammatory parameters and cardiometabolic risk factors. Seventeen clinically healthy subjects were included to consume SD or BY bread for 4 weeks each, and blood analyses were carried out. The consumption of "Verna" bread obtained with both leavening agents led to a significant improvement of LDL cholesterol. A reduction of -10.6% and -8.53% was observed after replacement with SD and BY bread, respectively. A significant increase in fasting blood glucose (+6%) was observed only after the intervention with BY bread. A 10.7% decrease of vascular endothelial growth factor was found after the SD bread replacement period. The consumption of "Verna" bread resulted significantly associated with an improvement in the cardiometabolic and inflammatory profile. However, only consumption of BY bread determined a significant increase in blood glucose levels.
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Nutritional Interventions in the Management of Fibromyalgia Syndrome.
Pagliai, G, Giangrandi, I, Dinu, M, Sofi, F, Colombini, B
Nutrients. 2020;12(9)
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Plain language summary
Fibromyalgia (FM) is a chronic pain condition, often presenting with widespread body pain, joint stiffness, sleep disorders, depression, anxiety, gastrointestinal and cognitive complaints. Despite being common, the cause of FM is not well understood. In the absence of effective treatments, the current management of FM involves a multidisciplinary approach utilizing pharmacological and non-pharmacological interventions. Growing evidence suggests a role for nutrition as a complementary strategy for FM management. This brief review summarises the possible impact of nutritional supplements and dietary interventions on FM. Previous reviews concluded that vitamin and mineral deficiencies themselves are unlikely to be significant in the development of FM. Yet, a few interventional studies investigating the use of Vitamin D, magnesium, iron and probiotics showed promising results. To date, there is no or limited evidence for the use of Vitamin C, E, selected amino acids, botanical or antioxidant supplements. Food-wise the inclusion of quality olive oil and the grain Khorasan proved helpful on FM presentation, whilst findings around the role of dietary monosodium glutamate and aspartame seem mixed. Regarding diet patterns, gluten-free, low-calorie, vegetarian, vegan, raw food or Mediterranean diets were all associated with improvement of symptoms. Equally a FODMAP diet can aid FM associated digestive complaints due to the significant overlap of Irritable Bowel Syndrome with FM. The authors concluded that the clinical application of dietary supplements in the management of FM remains controversial. Yet, dietary interventions appear to be an effective tool in the management of FM. Since various diet interventions demonstrated benefits, dietary adequacy and weight loss may be most critical from a clinical perspective.
Abstract
Fibromyalgia (FM) is a multifactorial syndrome of unknown etiology, characterized by widespread chronic pain and various somatic and psychological manifestations. The management of FM requires a multidisciplinary approach combining both pharmacological and nonpharmacological strategies. Among nonpharmacological strategies, growing evidence suggests a potential beneficial role for nutrition. This review summarizes the possible relationship between FM and nutrition, exploring the available evidence on the effect of dietary supplements and dietary interventions in these patients. Analysis of the literature has shown that the role of dietary supplements remains controversial, although clinical trials with vitamin D, magnesium, iron and probiotics' supplementation show promising results. With regard to dietary interventions, the administration of olive oil, the replacement diet with ancient grains, low-calorie diets, the low FODMAPs diet, the gluten-free diet, the monosodium glutamate and aspartame-free diet, vegetarian diets as well as the Mediterranean diet all appear to be effective in reducing the FM symptoms. These results may suggest that weight loss, together with the psychosomatic component of the disease, should be taken into account. Therefore, although dietary aspects appear to be a promising complementary approach to the treatment of FM, further research is needed to provide the most effective strategies for the management of FM.
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A Khorasan Wheat-Based Replacement Diet Improves Risk Profile of Patients With Nonalcoholic Fatty Liver Disease (NAFLD): A Randomized Clinical Trial.
Dinu, M, Whittaker, A, Pagliai, G, Giangrandi, I, Colombini, B, Gori, AM, Fiorillo, C, Becatti, M, Casini, A, Benedettelli, S, et al
Journal of the American College of Nutrition. 2018;37(6):508-514
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Non-alcoholic fatty liver disease (NAFLD) is prevalent, however early intervention with lifestyle modifications such as weight loss, dietary therapy and physical activity may reverse it. Previous studies have shown that the Mediterranean diet, which includes a large proportion of grains, may reduce NAFLD. However no prior studies have assessed grains in isolation on these individuals. This randomised double blind parallel arm study aimed to assess the effects of a replacement diet with ancient khorasan wheat products on patients with NAFLD. 40 people with mild- moderate NAFLD were assigned to either khorasan wheat diet or a modern wheat grain diet for three months. This comparatively small study found that a khorasan wheat based diet improved liver function and inflammation. However regardless of the diet, measures of oxidative stress, which assesses the imbalance of free radicals and antioxidants in the body, was significantly reduced and some individuals were shown to regress from moderate to mild NAFLD. Nutrition practitioners who have clients with mild-moderate NAFLD may recommend a khorasan wheat based diet in the short term to improve biochemical and inflammatory markers and to potentially reverse disease development.
Abstract
OBJECTIVE KAMUT khorasan is an ancient grain with widely acclaimed health benefits. The aim of this study was to investigate the effects of a replacement diet with ancient khorasan wheat products in patients with NAFLD, in comparison to a similar replacement diet with control products made from organic semi-whole-grain modern wheat. METHODS Forty NAFLD patients (12 M/28 F; age 55.2 ± 10.4 years) with mild to moderate liver steatosis were included. The experimental design was a randomized, double-blind, parallel-arm study with 20 participants assigned to consume either KAMUT khorasan or control wheat products (pasta, bread, crackers, biscuits) over a 3-month period. Anthropometric measurements, blood analyses, and ultrasonography examination were performed at both the beginning and end of each dietary intervention. RESULTS After the implementation of a general linear model for repeated measurements adjusted for baseline demographic details, risk factors, and medication, alanine aminotransferase (ALT) was significantly reduced by 12%, aspartate aminotransferase (AST) by 14%, alkaline phosphatase (ALP) by 8%, and cholesterol by 6% only in the khorasan group (p < 0.05 for all). Similarly, significant reductions in circulating proinflammatory tumor necrosis factor-alpha by 50%, interleukin l-receptor antagonist-alpha by 37%, interleukin-8 by 24%, and interferon gamma by 24% were evident only in participants who consumed the khorasan products (p < 0.05 for all). Finally, significant improvements in the liver steatosis grading, Doppler perfusion index values, and reactive oxygen species (ROS) production were evident after consumption of both the khorasan and control products. CONCLUSIONS This study suggests that a short-term replacement diet with ancient KAMUT khorasan products is most effective in reducing metabolic risk factors and ameliorating the liver profile in patients with NAFLD.
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Effects of a 1-year dietary intervention with n-3 polyunsaturated fatty acid-enriched olive oil on non-alcoholic fatty liver disease patients: a preliminary study.
Sofi, F, Giangrandi, I, Cesari, F, Corsani, I, Abbate, R, Gensini, GF, Casini, A
International journal of food sciences and nutrition. 2010;(8):792-802
Abstract
BACKGROUND AND AIMS Non-alcoholic fatty liver disease (NAFLD) is a worldwide diffuse condition due to alimentary, environment and genetic factors. The aim of our preliminary study was to evaluate the effectiveness of long-term consumption of food enriched with n-3 polyunsaturated fatty acids (PUFA) in patients with NAFLD. METHODS Eleven patients were enrolled; six (four males, two females) were planned for oral administration of 6.5 ml olive oil enriched with n-3 PUFA for 12 months, while five (four males, one female) were used as controls. RESULTS Consumption of olive oil enriched with n-3 PUFA demonstrated a significant improvement of liver echo-texture and of the Doppler Perfusion Index after 12 months (after: 0.19 ± 0.02 vs. pre: 0.15 ± 0.03; P < 0.05), whereas no significant changes were seen at the end of follow-up in controls. Moreover, patients who consumed the olive oil enriched with n-3 PUFA showed a significant amelioration of liver enzymes, and of triglycerides (post: 132.8 ± 63.7 vs. pre: 164.5 ± 85.5 mg/dl; P = 0.04) in a general linear model adjusted for age and gender. Interestingly, patients reported to have a significant increase of adiponectin levels (post: 1,487.9 ± 96.7 vs. pre: 1,143 ± 24.8 μg/ml; P = 0.04). CONCLUSION The results of this preliminary study showed that long-term consumption of olive oil enriched with n-3 PUFA in patients with NAFLD is able to decrease circulating liver enzymes and triglycerides, with a significant improvement of adiponectin levels.