Very-low-calorie ketogenic diet vs hypocaloric balanced diet in the prevention of high-frequency episodic migraine: the EMIKETO randomized, controlled trial.

BACKGROUND: Migraine is the second world's cause of disability. Among non-pharmacological treatments, nutritional intervention, particularly ketogenic diet, represents one of the most promising approaches. METHODS: This a prospective, single center, randomized, controlled study aimed at evaluating the efficacy of a very low-calorie ketogenic diet (VLCKD) compared to a hypocaloric balanced diet (HBD) in migraine prophylaxis in patients affected by high-frequency episodic migraine (HFEM) with a Body Mass Index (BMI) > 27 kg/m2. Fifty-seven patients were randomly assigned to a VLCKD (group 1) or HBD (group 2). Group 1 patients followed a VLCKD for 8 weeks, followed by a low calorie diet (LCD, weeks 9-12), and a HBD (weeks 13-24), whereas group 2 patients followed a HBD from week 0 to 24. Anthropometric indexes, urine and blood chemistry were assessed at enrollment, baseline, weeks 4, 8, 12, and 24. Migraine characteristics were evaluated at baseline, weeks 8, 12 and 24. Change in monthly migraine days (MMDs) at weeks 5-8 compared to baseline was the primary endpoint. Secondary endpoints encompassed changes in visual analogue scale (VAS), Headache Impact Test-6 (HIT-6) and Short Form Health Survey-36 (SF-36) scores. We also studied effects on circulating lymphocytes and markers of inflammation, changes in plasma aldosterone and renin levels before and after VLCKD or HBD treatment. RESULTS: Reduction from baseline in MMDs was greater in VLCKD compared to HBD group at week 8 (p = 0.008), at week 12 (p = 0.007), when ketosis had been interrupted by carbohydrates reintroduction, and at week 24 (p = 0.042), when all patients were following the same dietary regimen. Quality of life scores (SF-36) were improved in VLCKD group at week 8 and 12, and were also improved in HBD group, but only at week 12. Weight-loss was significantly higher in VLCKD group at week 8 (p = 0.002) and week 12 (p = 0.020). At the end of the study weight loss was maintained in VLCKD group whereas a slight weight regain was observed in HBD group. Inflammatory indexes, namely C reactive protein (CRP), neutrophil to lymphocyte ratio (NLR) and total white blood cell count (WBC) were significantly reduced (p < 0.05) in VLCKD group at week 12. Aldosterone plasma level were significantly increased in both groups at week 8, particularly in VLCKD group. However, electrolytes and renin plasma levels were never altered throughout the study in both groups. CONCLUSIONS: VLCKD is more effective than HBD in reducing MMD in patients with HFEM and represents an effective prophylaxis in patients with overweight/obesity. Trial registration ClinicalTrials.gov identifier: NCT04360148.

Ketogenic Diet as a Possible Non-pharmacological Therapy in Main Endocrine Diseases of the Female Reproductive System: A Practical Guide for Nutritionists.

PURPOSEOF REVIEW: This narrative review explored the role of ketogenic diets (KDs) in improving fertility outcomes, low-grade inflammation, body weight, visceral adipose tissue, and its potential use in certain types of cancer, through its favorable actions on mitochondrial function, reactive oxygen species generation, chronic inflammation, and tumor growth inhibition. RECENT FINDINGS  : Nutrition is crucial to maintain the female reproductive system's health. Evidence on the association between diet and female reproductive system has greatly expanded over the last decade, leading to the identification of specific diet therapy, particularly KDs. KDs has been proved to be an effective weight-loss tool. To date, KDs is being increasingly used in the treatment of many diseases, such as obesity, type 2 diabetes mellitus. KDs is a dietary intervention capable of ameliorating the inflammatory state and oxidative stress through several mechanisms. Due to the increasing use of KDs beyond obesity, this literature review will provide the latest scientific evidence of its possible use in common disorders of the female endocrine-reproductive tract, and a practical guide to its use in these patients.

Nutritional management of type 2 diabetes in subjects with obesity: an international guideline for clinical practice.

Type 2 diabetes mellitus (T2DM) and obesity represent a global public health problem. Current nutritional recommendations focused on weight loss and overall dietary quality. However, there is no consensus on the optimal macronutrient composition of the diet, particularly for the long-term management of T2DM in subjects with obesity. An international panel of experts reviewed and critically appraised the updated literature published on the topic. This review primarily examines the evidence for areas of consensus and uncertainty about nutritional therapy in patients with T2DM and obesity. The aim of this article is to provide nutritional advice to manage these patients in clinical practice.

Could ketogenic diet "starve" cancer? Emerging evidence.

Cancer cells (CCs) predominantly use aerobic glycolysis (Warburg effect) for their metabolism. This important characteristic of CCs represents a potential metabolic pathway to be targeted in the context of tumor treatment. Being this mechanism related to nutrient oxidation, dietary manipulation has been hypothesized as an important strategy during tumor treatment. Ketogenic diet (KD) is a dietary pattern characterized by high fat intake, moderate-to-low protein consumption, and very-low-carbohydrate intake (<50 g), which in cancer setting may target CCs metabolism, potentially influencing both tumor treatment and prognosis. Several mechanisms, far beyond the originally proposed inhibition of glucose/insulin signaling, can underpin the effectiveness of KD in cancer management, ranging from oxidative stress, mitochondrial metabolism, and inflammation. The role of a qualified Nutritionist is essential to reduce and manage the short and long-term complications of this dietary therapy, which must be personalized to the individual patient for the planning of tailored KD protocol in cancer patients. In the present review, we summarize the proposed antitumor mechanisms of KD, the application of KD in cancer patients with obesity and cachexia, and the preclinical and clinical evidence on KD therapy in cancer.

Reply to Berk et al. Comment on "Moriconi et al. Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes. Nutrients 2021, 13, 758".

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Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes.

Obesity-related type 2 diabetes represents one of the most difficult challenges for the healthcare system. This retrospective study aims to determine the efficacy, safety and durability of a very-low-calorie ketogenic diet (VLCKD), compared to a standard low-calorie diet (LCD) on weight-loss, glycemic management, eating behavior and quality of life in patients with type 2 diabetes (T2DM) and obesity. Thirty patients with obesity and T2DM, aged between 35 and 75 years, who met the inclusion criteria and accepted to adhere to a VLCKD or a LCD nutritional program, were consecutively selected from our electronic database. Fifteen patients followed a structured VLCKD protocol, fifteen followed a classical LCD. At the beginning of the nutritional protocol, all patients were asked to stop any antidiabetic medications, with the exception of metformin. Data were collected at baseline and after 3 (T1) and 12 (T2) months. At T1 and T2, BMI was significantly reduced in the VLCKD group (p < 0.001), whereas it remained substantially unchanged in the LCD group. HbA1c was significantly reduced in the VLCKD group (p = 0.002), whereas a slight, although not significant, decrease was observed in the LCD group. Quality of life and eating behavior scores were improved in the VLCKD group, whereas no significant changes were reported in the LCD group, both at T1 and T2. At the end of the study, in the VLCKD group 26.6% of patients had stopped all antidiabetic medications, and 73.3% were taking only metformin, whereas 46.6% of LCD patients had to increase antidiabetic medications. The study confirms a valuable therapeutic effect of VLCKD in the long-term management of obesity and T2DM and its potential contribution to remission of the disease.

Neuroendocrine and Metabolic Effects of Low-Calorie and Non-Calorie Sweeteners.

Since excessive sugar consumption has been related to the development of chronic metabolic diseases prevalent in the western world, the use of sweeteners has gradually increased worldwide over the last few years. Although low- and non-calorie sweeteners may represent a valuable tool to reduce calorie intake and prevent weight gain, studies investigating the safety and efficacy of these compounds in the short- and long-term period are scarce and controversial. Therefore, future studies will need to elucidate the potential beneficial and/or detrimental effects of different types of sweeteners on metabolic health (energy balance, appetite, body weight, cardiometabolic risk factors) in healthy subjects and patients with diabetes, obesity and metabolic syndrome. In this regard, the impact of different sweeteners on central nervous system, gut hormones and gut microbiota is important, given the strong implications that changes in such systems may have for human health. The aim of this narrative review is to summarize the current evidence for the neuroendocrine and metabolic effects of sweeteners, as well as their impact on gut microbiota. Finally, we briefly discuss the advantages of the use of sweeteners in the context of very-low calorie ketogenic diets.

MOSH Syndrome (Male Obesity Secondary Hypogonadism): Clinical Assessment and Possible Therapeutic Approaches.

Male obesity secondary hypogonadism (MOSH) impairs fertility, sexual function, bone mineralization, fat metabolism, cognitive function, deteriorates muscle mass and alters body composition. The aim of this pilot study was to evaluate the effect of dietary intervention and physical activity on the MOSH patient's hormonal profile after a 10% weight loss compared to baseline. Fourteen male patients were enrolled. Hormonal, lipid, glycemic profiles and body composition were determined at baseline and after a 10% weight loss. Aging Male Symptoms Scale (AMS) and Yale Food Addiction Scale (YFAS) were administered to patients in order to investigate hypogonadal symptoms and food addiction. Compared to baseline, a significant increase of Total Testosterone (TT) (300.2 ± 79.5 ng/dL vs. 408.3 ± 125.9 ng/dL, p = 0.002, 95% CI 26.8; 167.7) and a reduction of 17-Beta Estradiol level (48.3 ± 14.9 pg/mL vs. 39.2 ± 15.2 pg/mL, p = 0.049, 95% CI 3.1; 0.0) were observed. Total Fat Mass (FM) percentage, android and gynoid fat mass percentage (39.2 ± 6.4% vs. 36.2 ± 5.8%, p = 0.0001, 95% CI 22.5; 62.3; 51.5 ± 6.8% vs. 47.6 ± 6.8%, p = 0.001, 95% CI 0.6; 1.8, vs. 39.2 ± 6.2% vs. 36.5 ± 6.3% p = 0.0001, 95% CI 0.9; 2.0 respectively) were significantly decreased after nutritional intervention. In addition, total Fat Free Mass (FFM) in kg was significantly reduced after 10% weight loss (62.3 ± 2.8 kg vs. 60.3 ± 7.7 kg, p = 0.002, 95% CI 45.0; 93.0). Lifestyle changes, specifically dietotherapy and physical activity, induce positive effects on hypogonadism due to obesity.

Impact of Mediterranean diet on metabolic syndrome, cancer and longevity.

Obesity symbolizes a major public health problem. Overweight and obesity are associated to the occurrence of the metabolic syndrome and to adipose tissue dysfunction. The adipose tissue is metabolically active and an endocrine organ, whose dysregulation causes a low-grade inflammatory state and ectopic fat depositions. The Mediterranean Diet represents a possible therapy for metabolic syndrome, preventing adiposopathy or "sick fat" formation.The Mediterranean Diet exerts protective effects in elderly subjects with and without baseline of chronic diseases. Recent studies have demonstrated a relationship between cancer and obesity. In the US, diet represents amount 30-35% of death causes related to cancer. Currently, the cancer is the second cause of death after cardiovascular diseases worldwide. Furthermore, populations living in the Mediterranean area have a decreased incidence of cancer compared with populations living in Northern Europe or the US, likely due to healthier dietary habits. The bioactive food components have a potential preventive action on cancer. The aims of this review are to evaluate the impact of Mediterranean Diet on onset, progression and regression of metabolic syndrome, cancer and on longevity.

Laparoscopic sleeve gastrectomy and medical management for the treatment of type 2 diabetes mellitus in non-morbidly obese patients: a single-center experience.

BACKGROUND: Type 2 diabetes mellitus (T2DM) and obesity are often associated in the same metabolic pathology and represent a significant public health problem. Although laparoscopic sleeve gastrectomy (LSG) is a relatively recent technique of bariatric surgery, it has shown to be efficient and safe and has obtained much support from physicians and patients. Several studies have highlighted the effects in terms of resolution and improvement of diabetes. SUBJECTS AND METHODS: From January 2009 to November 2012, 15 patients in Obesity Class II (body mass index [BMI], 37.9 ± 1.5 kg/m(2); baseline weight, 102.7 ± 11.6 kg) with uncontrolled T2DM despite taking a glucose-lowering drug therapy (glycated hemoglobin [HbA1c], 8.1 ± 0.6%) underwent LSG and advanced practice medical management in accordance with the American Diabetes Association guidelines. All patients were subjected to follow-up controls with anthropometric and metabolic indices at 5, 15, 30, and 60 days, and at 6 and 12 months after surgery, remission of diabetes was also evaluated. RESULTS: At 1 year after surgery, the mean excess weight loss percentage (EWL%) was 58.4%, and the mean BMI had decreased from the preoperative value of 37.9 kg/m(2) to 30.4 kg/m(2). The average reduction in HbA1c was 2.5 (30.9%). The mean homeostatic model assessment of insulin resistance decreased from 13.3 to 4.9. Overall, during the period of observation, four patients (26.7%) had started drug therapy again, six patients had complete remission (40%), and five patients had partial remission (33.3%). CONCLUSIONS: LSG not only makes it possible to attain a significant EWL% in obese patients, but also a remission or improvement of diabetes. Further studies are required to determine the duration of the effect and the role of different factors involved.