Very Low-calorie Ketogenic Diet Research Articles

The Use of Evidence-Based Dietary Interventions for the Management of Obesity

Obesity has become a serious public health issue worldwide, with its prevalence steadily increasing. The potential consequences of this chronic disease, including cardiovascular disease, increased morbidity, and mortality, pose a significant burden on individuals and healthcare systems. Evidence has established that lifestyle and dietary modification are central to achieving effective weight loss. One approach shown to be efficacious in achieving weight loss is the use of a very low calorie ketogenic diet (VLCKD), which includes stages of induced ketosis, followed by a reintroduction to a low calorie diet and maintenance diet. Such regimens have been shown to result in sustained weight loss and, for some people, remission of Type 2 diabetes (T2D). A similar approach, which may also be a component of the VLCKD, is the use of total or partial replacement of meals using nutritionally complete shakes, bars, or soups. These may be combined with other weight loss measures, including bariatric surgery or medications. It is important that such programmes are delivered in a structured, medically-monitored, and supportive environment, such as laid out by Obesity Canada’s ‘5As’ programme. An ‘obesity shared medical appointment’ model is a multidisciplinary approach, whereby a patient with obesity is seen by a number of healthcare specialists, depending on their comorbidities. The patient also has the opportunity to meet with obesity specialists and engage in monthly patient support groups, all of which have been shown to be successful interventions in helping patients lead a healthier lifestyle, and gain more control over their weight. The following proceedings are based on talks given by leading obesity experts, presented at the 30th European Congress on Obesity (ECO 2023), which took place in Dublin, Republic of Ireland, in May 2023.

Effects of a Very-Low-Calorie Ketogenic Diet on the Fecal and Urinary Volatilome in an Obese Patient Cohort: A Preliminary Investigation.

Several recent studies deepened the strong connection between gut microbiota and obesity. The effectiveness of the very-low-calorie ketogenic diet (VLCKD) has been measured in terms of positive impact on the host homeostasis, but little is known of the modification exerted on the intestinal metabolome. To inspect this complex relationship, we analyzed both fecal and urinary metabolome in terms of volatile organic compounds (VOCs) by the GC-MS method in 25 obese patients that were under VLCKD for eight weeks. Partial least square discriminant analysis evidenced specific urinary and fecal metabolites whose profile can be considered a signature of a partial restore toward the host eubiosis. Specifically, among various keystone VOCs, the decreased concentration of four statistically significant fecal esters (i.e., propanoic acid pentyl ester, butanoic acid hexyl ester, butanoic acid pentyl ester, and pentanoic acid butyl ester) supports the positive effect of VLCKD treatment. Our pilot study results suggest a potential positive effect of VLCKD intervention affecting fecal and urinary volatilome profiles from obese patients. Meta-omics techniques including the study of genes and transcripts will help in developing new interventions useful in preventing or treating obesity and its associated health problems.

Can the ketogenic diet improve our dreams? Effect of very low-calorie ketogenic diet (VLCKD) on sleep quality

BackgroundObesity is a condition that is often associated with sleep disorders, including reduced sleep quality (SQ). Very low calorie ketogenic diet (VLCKD) has proven to be effective in the management of obesity and associated metabolic disorders. However, little is still known about the effects of this promising nutritional protocol on SQ. Thus, the purpose of this study was to investigate the short-term effect of VLCKD on SQ in women with overweight/obesity and if any changes, to identify the predictive factor that through VLCKD modified SQ.MethodsWere consecutively enrolled a total of 324 subjects, who met the inclusion criteria and accepted to adhere to VLCKD. Assessment of nutritional status, including anthropometric measurements (height, weight, and waist circumference), bioelectrical impedance analysis (phase-sensitive system, 50 kHz BIA 101 RJL, Akern Bioresearch, Florence, Italy Akern), high sensitivity C reactive protein levels (hs-CRP), and SQ were carried out at baseline and after 31 days of active stage of VLCKD. SQ was evaluated using the validated questionnaire Pittsburgh Sleep Quality Index (PSQI).ResultsIn addition to the expected general improvement of anthropometric parameters and body composition, VLCKD improved significantly SQ, as demonstrated by the improvement of all parameters included in the PSQI questionnaire (p < 0.001). Both at baseline and after 31 days of active stage of VLCKD, the PSQI score was significantly associated with BMI, waist circumference, fat mass, fat free mass (p < 0.001 for all) and hs-CRP (p = 0.023). PhA was negatively associated with PSQI score only at baseline (p < 0.001). ∆% PSQI positively correlated with ∆% BMI, ∆% fat mass, ∆% hs-CRP (p < 0.001 for all) and negatively correlated with ∆% fat free mass (p < 0.001), and ∆% PhA (p = 0.031). In the multiple regression analysis ∆% fat mass represented the only predictor of changes in SQ after VLCKD. Finally, in the ROC analysis, a threshold value of ∆% fat mass > − 8.4% predicted improvement in SQ (p < 0.001).ConclusionIn conclusion, VLCKD determines an improvement of SQ in women with overweight and obesity, that was mostly mediated by the reduction of fat mass related to this nutritional protocol.Graphical

Efficacy, safety and tolerability of very low-calorie ketogenic diet in obese women with fibromyalgia: a pilot interventional study.

Obesity can worsen fibromyalgia (FM) and very low-calorie ketogenic diet (VLCKD) is a potential therapeutic option for diseases that share clinical and pathophysiological features with FM. In this pilot interventional study, we investigated the effects of VLCKD in obese women with FM. Female patients with FM and a body mass index (BMI) ≥ 30 kg/m2 were eligible for VLCKD. The ketogenic phase (T0 to T8) was followed by progressive reintroduction of carbohydrates (T8 to T20). Changes in BMI, Fibromyalgia Impact Questionnaire (FIQ), Hospital Anxiety and Depression Scale (HADS), EuroQol 5D (EQ-5D) and 36-item Short Form Health Survey (SF-36) were evaluated. A change of 14% in FIQ was considered clinically relevant. The longitudinal association between BMI and patient-reported outcomes (PROs) was assessed using generalized estimating equations. Twenty women were enrolled. Two discontinued the intervention. The mean age of the 18 patients who reached T20 was 51.3 years and mean BMI was 37.2 kg/m2. All patients lost weight during the first period of VLCKD and this achievement was maintained at T20. Mean BMI decreased from 37.2 kg/m2 at T0 to 34.8 kg/m2 at T4, 33.5 kg/m2 at T8 and 32.1 kg/m2 at T20 (p < 0.001). A significant reduction of mean FIQ from 61.7 at T0 to 37.0 at T4 and to 38.7 at T8 (p < 0.001) was observed and it was maintained at T20 with a mean FIQ of 39.1 (p = 0.002). Similar results were obtained for HADS, EQ-5D and SF-36. Analysing each participant, the reduction of FIQ was clinically meaningful in 16 patients (89%) at T4, in 13 (72%) at T8 and in 14 (78%) at T20. No significant association was observed between change in BMI and improvement of the PROs over time. Adverse effects were mild and transient. No major safety concerns emerged. These are the first data on the efficacy of VLCKD in FM. All patients achieved improvement in different domains of the disease, which was maintained also after carbohydrate reintroduction. Our results suggest that ketosis might exert beneficial effects in FM beyond the rapid weight loss. This trial is registered on ClinicalTrials.gov, number NCT05848544.

The effect of dietary approaches to stop hypertension and ketogenic diets intervention on serum uric acid concentration: a systematic review and meta-analysis of randomized controlled trials

Hyperuricemia as a risk factor for metabolic diseases is proved to be profoundly modified by dietary approaches. This systematic review and meta-analysis of randomized control trials (RCT) was conducted to investigate the effect of two nutritional interventions; dietary approaches to stop hypertension (DASH) diet and ketogenic diet (KD) on serum uric acid (UA) concentrations. Our systematic search was for RCTs in which KD or DASH diet were assigned to adults for at least 2 weeks or more. Until March 2023 in Embase, Web of Science, PubMed, and Scopus databases, 10 eligible RCTs that intervened with DASH diet (n = 4) or KD (n = 6) and had provided laboratory data on serum UA were found. Summary effect was calculated by random-effects model. Results from the meta-analysis of the 4 DASH diet RCTs with a total of 590 participants revealed significant decrease in serum UA after at least 4 weeks of interventions (mean difference (MD) = ‒0.25; 95% CI ‒0.4 to ‒0.1 mg/dL; p < 0.01; I2 = 0%). The pooled meta-analysis of the 6 included RCTs of KD reporting data of 267 participants showed no significant changes in serum UA (MD = 0.26; 95% CI ‒0.47 to 0.98 mg/dL, I2 = 95.32%). However, a non-significant reduction of UA in the subgroup analysis of very low-calorie KD (VLCKD) studies (MD = ‒0.04; 95% CI ‒0.29 to 0.22, I2 = 0%) was obtained. DASH diet has an ameliorating effect on serum UA and may be recommended for hyperuricemia states such as gout. In addition, we have shown that serum UA level following KD remained unchanged. Although, in view of the heterogeneity across the studies, further investigations are needed to determine the effect of KD and VLKD on serum UA concentrations.

Efficacy of the Very Low-Calorie Ketogenic Diet (VLCKD) in postmenopausal women with obesity: better to be “owls” or “larks”?

Nutritional approaches (NA) are the cornerstone of obesity therapy, but their optimal design for postmenopausal women, a population with a high prevalence of obesity, is debated. In addition, recent studies have reported that chronotype (reflecting an individual's preference for sleep, eating and activity times over a 24h period) plays a role in both the development of metabolic comorbidities and in determining eating habits in obesity. However, little is known whether the chronotype can predict the efficacy of (NA) in postmenopausal women with obesity (PWO). The aim of this study was to investigate whether chronotype categories may play a role in determining the efficacy of the Very-Low Calorie Ketogenic Diet (VLCKD) in terms of weight loss (WL) and body composition change in PWO.

The Effects of a Very-Low-Calorie Ketogenic Diet on the Intestinal Barrier Integrity and Function in Patients with Obesity: A Pilot Study.

The very-low-calorie ketogenic diet (VLCKD) is effective and safe for obese individuals, but limited information exists on its impact on the intestinal barrier. This study analyzed the effects of 8 weeks of VLCKD on 24 obese patients (11M/13F). Carbohydrate intake was fixed at 20-50 g/day, while protein and lipid intake varied from 1-1.4 g/kg of ideal body weight and 15-30 g per day, respectively. Daily calorie intake was below 800 kcal. The lactulose-mannitol absorption test assessed small intestinal permeability. Multiple markers, such as serum and fecal zonulin, fatty acid-binding protein, diamine oxidase concentrations, urinary dysbiosis markers (indican and skatole), and circulating lipopolysaccharide levels, were analyzed. Inflammation markers (serum interleukin 6, 8, 10, and tumor necrosis factor-α concentrations) were also evaluated. The results showed significant reductions in weight, BMI, and waist circumference post-diet. However, the lactulose-mannitol ratio increased by 76.5%, and a significant increase in dysbiosis markers at the end of the diet occurred. This trend was particularly evident in a subgroup of patients. Despite initial benefits, the VLCKD might negatively affect the intestinal barrier function in obese patients, potentially worsening their compromised intestinal balance.

Effects of ketogenic diet on health outcomes: an umbrella review of meta-analyses of randomized clinical trials

BackgroundSystematic reviews and meta-analyses of randomized clinical trials (RCTs) have reported the benefits of ketogenic diets (KD) in various participants such as patients with epilepsy and adults with overweight or obesity. Nevertheless, there has been little synthesis of the strength and quality of this evidence in aggregate.MethodsTo grade the evidence from published meta-analyses of RCTs that assessed the association of KD, ketogenic low-carbohydrate high-fat diet (K-LCHF), and very low-calorie KD (VLCKD) with health outcomes, PubMed, EMBASE, Epistemonikos, and Cochrane database of systematic reviews were searched up to February 15, 2023. Meta-analyses of RCTs of KD were included. Meta-analyses were re-performed using a random-effects model. The quality of evidence per association provided in meta-analyses was rated by the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) criteria as high, moderate, low, and very low.ResultsWe included 17 meta-analyses comprising 68 RCTs (median [interquartile range, IQR] sample size of 42 [20–104] participants and follow-up period of 13 [8–36] weeks) and 115 unique associations. There were 51 statistically significant associations (44%) of which four associations were supported by high-quality evidence (reduced triglyceride (n = 2), seizure frequency (n = 1) and increased low-density lipoprotein cholesterol (LDL-C) (n = 1)) and four associations supported by moderate-quality evidence (decrease in body weight, respiratory exchange ratio (RER), hemoglobin A1c, and increased total cholesterol). The remaining associations were supported by very low (26 associations) to low (17 associations) quality evidence. In overweight or obese adults, VLCKD was significantly associated with improvement in anthropometric and cardiometabolic outcomes without worsening muscle mass, LDL-C, and total cholesterol. K-LCHF was associated with reduced body weight and body fat percentage, but also reduced muscle mass in healthy participants.ConclusionsThis umbrella review found beneficial associations of KD supported by moderate to high-quality evidence on seizure and several cardiometabolic parameters. However, KD was associated with a clinically meaningful increase in LDL-C. Clinical trials with long-term follow-up are warranted to investigate whether the short-term effects of KD will translate to beneficial effects on clinical outcomes such as cardiovascular events and mortality.

(055) Application of a Very Low Calorie Ketogenic Diet (VLCKD) Protocol in Women's Endocrinology: Psychosexual Correlates of Weight Loss

Abstract Introduction The role of obesity in female sexuality is controversial and there are no intervention studies aimed at evaluating the effect of the Very Low Calories Ketogenic Diet (VLCKD) on female sexual function, in particular on arousal. Objective To evaluate the psychosexual correlates of obesity and Metabolic Syndrome (MetS) in a sample of women consulting for sexual symptoms; to investigate the change in measures of arousal after weight loss obtained with VLCKD. Methods In a retrospective study, n=322 women consulting for sexual symptoms were enrolled. The patients underwent a clinical, laboratory, sexual and psychological examination and were studied by color-Doppler ultrasound for the evaluation of genital vascularization, with measurement of the Pulsatility Index (PI) of the clitoral artery. They completed the Female Sexual Function Index (FSFI), Female Sexual Distress Scale - Revised (FSDS-R), Body Uneasiness Test, Eating Disorder Examination Questionnaire (EDE Q), and Middlesex Hospital Questionnaire, for psychiatric symptoms. Twelve patients underwent a nutritional intervention aimed at weight loss, based on a VLCKD protocol. These cases were compared with patients treated with different strategies for sexual symptoms, in a 1:1 case-control study (matched for BMI, age and menopausal status). Results In the total sample, clitoral PI was significantly higher in obese women (p = 0.018) and in those diagnosed with MetS (p=0.043). A statistically significant inverse correlation emerged between WC ≥ 88 cm and FSFI Arousal score (p=0.028). In patients undergoing a nutritional intervention with VCLKD protocol (n=12), after a mean follow-up of 20+-2 weeks, BMI showed a reduction of 6.7+-2.8 kg/m2 (p&amp;lt;0.001) and WC of 14.3+-5.2 cm (p&amp;lt;0.001), with fat mass loss of 14.6+-5.4 kg (-37.1%; p&amp;lt;0.001). At follow-up, the total FSFI and FSDS-R scores significantly improved (17.0+-13.6 vs. 11.2+-7.9, p=0.016, and 7.4+-8.3 vs. 13.3+-10.6, p=0.039, respectively). Among the FSFI subdomains, Arousal showed a significant increase (p=0.035). We also observed an improvement in EDE total score (p=0.032), Shape (p=0.008) and Weight subscales (p=0.011), BUT-B Positive Symptoms Distress Index (p=0.009) and BUT-A Body Image Concerns (p=0.043), and MHQ total score (p&amp;lt;0.001). The clitoral artery PI at follow-up showed a non-significant reduction. At multivariate analysis, the change in the Total FSFI was correlated with the BUT-B PSDI score change (p=0.031) and the EDE Shape change (p=0.043), when including DeltaMHQ and DeltaWC as further covariates. Finally, in a 1:1 case-control study, a significant difference emerged in the improvement of FSFI total score, which was more relevant in cases than in controls (p=0.046); on the other hand, there was no difference in the change in FSDS-R score between cases and controls. Conclusions Our data suggest that weight loss obtained by VLCKD is associated with an improvement in sexual function, and in particular in Arousal, whose change could be mediated by improved body image parameters. The effect of weight loss on cardiometabolic risk factors related to sexual dysfunction requires dedicated longitudinal studies, with the use of objective methods. Disclosure No

Chronotype as a predictor of weight loss and body composition improvements in women with overweight or obesity undergoing a very low-calorie ketogenic diet (VLCKD)

Recent studies reported that chronotype play a role in the development of metabolic comorbidities and in determining dietary habits in obesity. However, little is known if chronotype could predict the efficacy of nutritional approaches for obesity. The aim of this study was to investigate whether chronotype categories can have a role in determining the efficacy of very low-calorie ketogenic diet (VLCKD) in terms of weight loss and changes of body composition in women with overweight or obesity. In this retrospective study we analyzed data from 248 women (BMI 36.03±5.20kg/m2, aged 38.76±14.05 years) clinically referred for weight loss and who completed a VLCKD program. In all women, we assessed anthropometric parameters (weight, height, and waist circumference), body composition and phase angle (through bioimpedance analysis, Akern BIA 101) at the baseline and after 31 days of active phase of VLCKD. Chronotype score was assessed using Morningness-Eveningness questionnaire (MEQ) at baseline. After 31 days of active phase of VLCKD all enrolled women experienced significant weight loss (p<0.001) and reduction of BMI (p<0.001), waist circumference (p<0.001), fat mass (kg and %) (p<0.001), and free fat mass (kg) (p<0.001). Women with evening chronotype experienced significantly less weight loss (p<0.001) and reduced fat mass (kg and %) (p<0.001), increased fat free mass (kg and %) (p<0.001) and phase angle (p<0.001) than women with morning chronotype. In addition, chronotype score correlated negatively with percentage changes in weight (p<0.001), BMI (p<0.001), waist circumference (p<0.001) and fat mass (p<0.001) and positively with fat free mass (p<0.001) and phase angle (p<0.001) from baseline to the 31st day of active phase of VLCKD. Using a linear regression model, chronotype score (p<0.001) was the main predictors of weight loss achieved with VLCKD. Evening chronotype is associated with a lower efficacy in terms of weight loss and improvements of body composition after VLCKD in obesity.

What role does the Very Low-Calorie Ketogenic Diet (VLCKD) in obesity-related kidney complications?

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Very-low-calorie-ketogenic-diet (VLCKD) as a nutritional therapeutical option for chronic management in obese patients with type 2 diabetes: a case report

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Very Low-Calorie Ketogenic Diet (VLCKD) as Pre-Operative First-Line Dietary Therapy in Patients with Obesity Who Are Candidates for Bariatric Surgery.

Bariatric surgery is currently the most effective method for achieving long-term weight loss and reducing the risk of comorbidities and mortality in individuals with severe obesity. The pre-operative diet is an important factor in determining patients' suitability for surgery, as well as their post-operative outcomes and success in achieving weight loss. Therefore, the nutritional management of bariatric patients requires specialized expertise. Very low-calorie diets and intragastric balloon placement have already been studied and shown to be effective in promoting pre-operative weight loss. In addition, the very low-calorie ketogenic diet has a well-established role in the treatment of obesity and type 2 diabetes mellitus, but its potential role as a pre-operative dietary treatment prior to bariatric surgery has received less attention. Thus, this article will provide a brief overview of the current evidence on the very low-calorie ketogenic diet as a pre-operative dietary treatment in patients with obesity who are candidates for bariatric surgery.

Efficacy of very low-calorie ketogenic diet with the Pronokal® method in obese women with polycystic ovary syndrome: a 16-week randomized controlled trial.

The aim of this study isto assess the efficacy of a very low-calorie ketogenic diet (VLCKD) method vs a Mediterranean low-calorie diet (LCD) in obese polycystic ovary syndrome (PCOS) women of a reproductive age. Randomized controlled open-label trial was performed in this study. The treatment period was 16 weeks; VLCKD for 8 weeks then LCD for 8 weeks, according to the Pronokal® method (experimental group; n = 15) vs Mediterranean LCD for 16 weeks (control group; n = 15). Ovulation monitoring was carried out at baseline and after 16 weeks, while a clinical exam, bioelectrical impedance analysis (BIA), anthropometry, and biochemical analyses were performed at baseline, at week 8, and at week 16. BMI decreased significantly in both groups and to a major extent in the experimental group (-13.7% vs -5.1%, P = 0.0003). Significant differences between the experimental and the control groups were also observed in the reduction of waist circumference (-11.4% vs -2.9%), BIA-measured body fat (-24.0% vs -8.1%), and free testosterone (-30.4% vs -12.6%) after 16 weeks (P = 0.0008, P = 0.0176, and P = 0.0009, respectively). Homeostatic model assessment for insulin resistance significantly decreased only in the experimental group (P = 0.0238) but without significant differences with respect to the control group (-23% vs -13.2%, P > 0.05). At baseline, 38.5% of participants in the experimental group and 14.3% of participants in the control group had ovulation, which increased to 84.6% (P = 0.031) and 35.7% (P > 0.05) at the end of the study, respectively. In obese PCOS patients, 16 weeks of VLCKD protocol with the Pronokal® method was more effective than Mediterranean LCD in reducing total and visceral fat, and in ameliorating hyperandrogenism and ovulatory dysfunction. To the best of our knowledge, this is the first randomized controlled trial on the use of the VLCKD method in obese PCOS. It demonstrates the superiority of VLCKD with respect to Mediterranean LCD in reducing BMI with an almost selective reduction of fat mass and a unique effect of VLCKD in reducing visceral adiposity, insulin resistance, and in increasing SHBG with a consequent reduction of free testosterone. Interestingly, this study also demonstrates the superiority of the VLCKD protocol in improving ovulation, whose occurrence increased by 46.1% in the group treated by the VLCKD method against a rise of 21.4% in the group treated by Mediterranean LCD. This study extends the therapeutic approach possibilities in obese PCOS women.

Insulin-resistance (IR) does not predict early weight regain following a simplified very low calorie ketogenic diet (VLCKD) for obesity management

Insulin-resistance (IR) does not predict early weight regain following a simplified very low calorie ketogenic diet (VLCKD) for obesity management

Efficacy, feasibility and tolerability of ketogenic diet for the treatment of poor response to bariatric surgery

PurposePoor response to bariatric surgery, namely insufficient weight loss (IWL) or weight regain (WR), is a critical issue in the treatment of obesity. The purpose of our study was to assess the efficacy, feasibility, and tolerability of very low-calorie ketogenic diet (VLCKD) for the management of this condition.MethodsA real-life prospective study was conducted on twenty-two patients who experienced poor response after bariatric surgery and followed a structured VLCKD. Anthropometric parameters, body composition, muscular strength, biochemical analyses, and nutritional behavior questionnaires were evaluated.ResultsA significant weight loss (mean 14.1 ± 4.8%), mostly due to fat mass, was observed during VLCKD with the preservation of muscular strength. The weight loss obtained allowed patients with IWL to reach a body weight significantly lower than that obtained at the post-bariatric surgery nadir and to report the body weight of patients with WR at the nadir observed after surgery. The significantly beneficial changes in nutritional behaviors and metabolic profiles were observed without variations in kidney and liver function, vitamins, and iron status. The nutritional regimen was well tolerated, and no significant side effects were detected.ConclusionOur data demonstrate the efficacy, feasibility, and tolerability of VLCKD in patients with poor response after bariatric surgery.

Very low-calorie ketogenic diet (VLCKD): an antihypertensive nutritional approach

BackgroundObesity is accompanied by hormonal, inflammatory and endothelial alterations. These alterations induce a stimulation of several other mechanisms that contribute to the hypertensive state and to increase the cardiovascular morbidity. This pilot, open - label, single- center, prospective clinical trial aimed to evaluate the effect of very low- calorie ketogenic diet (VLCKD) on blood pressure (BP) in women with of obesity and hypertension.MethodsA total of 137 women, who met the inclusion criteria and accepted to adhere to VLCKD, were consecutively enrolled. Assessment of anthropometric parameters (weight, height, and waist circumference), body composition (through bioelectrical impedance analysis), systolic (SBP) and diastolic blood pressure (DBP) and blood sample collection were carried out at baseline and after 45 days of the active phase of VLCKD.ResultsAfter VLCKD all the women experienced a significant reduction in body weight and an overall improvement of body composition parameters. In addition, high sensitivity C reactive protein (hs- CRP) levels were significantly diminished (p < 0.001), while phase angle (PhA) increased by almost 9% (p < 0.001). Interestingly, both SBP and DBP were significantly improved (-12.89% and − 10.77%, respectively; p < 0.001). At baseline, SBP and DBP showed statistically significant correlations with body mass index (BMI), waist circumference, hs-CRP levels, PhA, total body water (TBW), extracellular water (ECW), Na / K ratio, and fat mass. Even after VLCKD, all correlations among SBP and DBP with the study variables were statistically significant, except for the association between DBP and Na / K ratio. Changes (%) in both SBP and DBP were associated with ∆BMI%, ∆PhA% and ∆hs- CRP levels (p < 0.001). In addition, only ∆SBP% was associated with ∆waist circumference (p = 0.017), ∆TBW (p = 0.017), and ∆fat mass (p < 0.001); while only ∆DBP% was associated with ∆ECW (p = 0.018), and ∆Na / K ratio (p = 0.048). After adjusting for ∆BMI, ∆WC, ∆PhA, ∆TBW, and ∆fat mass, the correlation between changes in ∆SBP and ∆hs -CRP levels remained statistically significant (p < 0.001). Similarly, the correlation between ∆DBP and ∆hs- CRP levels also remained statistically significant after adjustment for ∆BMI, ∆PhA, ∆Na / K ratio, and ∆ECW (p < 0.001). From multiple regression analysis ∆hs- CRP levels seemed to be the main predictor of changes of BP (p < 0.001).ConclusionVLCKD reduces BP in women with of obesity and hypertension in a safely manner.

The Effects of Eight Weeks' Very Low-Calorie Ketogenic Diet (VLCKD) on Liver Health in Subjects Affected by Overweight and Obesity.

Very low-calorie ketogenic diets (VLCKD) are widely employed in successful weight-loss strategies. Herein, we evaluated the efficacy and safety of a VLCKD on non-alcoholic fatty liver disease (NAFLD) and parameters commonly associated with this condition in overweight and obese subjects who did not take any drugs. This prospective, real-life study included thirty-three participants who followed a VLCKD for 8 weeks. NAFLD was diagnosed using transient elastography (FibroScan). Data on anthropometric measurements, bioimpedance analysis, and biochemical assays were gathered both before and after the dietary intervention. BMI (kg/m2) (from 33.84 ± 6.55 to 30.89 ± 6.38, p < 0.01), waist circumference (cm) (from 106.67 ± 15.51 to 98.64 ± 16.21, p < 0.01), and fat mass (Kg) (from 38.47 ± 12.59 to 30.98 ± 12.39, p < 0.01) were significantly lower after VLCKD. CAP (db/m), the FibroScan parameter quantifying fatty liver accumulation, showed a significant reduction after VLCKD (from 266.61 ± 67.96 to 223 ± 64.19, p < 0.01). After VLCKD, the fatty liver index (FLI), a benchmark of steatosis, also revealed a significant decline (from 62.82 ± 27.46 to 44.09 ± 31.24, p < 0.01). Moreover, fasting blood glucose, insulin, triglycerides, total cholesterol, LDL-cholesterol, ALT, γGT, and FT3 blood concentrations, as well as insulin resistance (quantified by HOMAIR) and systolic and diastolic blood pressure levels, were significantly lower after VLCKD (p < 0.01 for all the parameters). By contrast, HDL-cholesterol, 25 (OH) vitamin D, and FT4 blood concentrations were higher after VLCKD (p < 0.01 for all parameters). The variation (δ) of CAP after VLCKD did not show a correlation with the δ of any other parameter investigated in this study. We conclude that VLCKD is a helpful approach for NAFLD independent of changes in factors commonly associated with NAFLD (obesity, fat mass, insulin resistance, lipids, and blood pressure) as well as vitamin D and thyroid hormone levels.

Predictors of weight loss in patients with obesity treated with a Very Low-Calorie Ketogenic Diet.

The Very Low-Calorie Ketogenic Diet (VLCKD) has emerged as a safe and effective intervention for the management of metabolic disease. Studies examining weight loss predictors are scarce and none has investigated such factors upon VLCKD treatment. Among the molecules involved in energy homeostasis and, more specifically, in metabolic changes induced by ketogenic diets, Fibroblast Growth Factor 21 (FGF21) is a hepatokine with physiology that is still unclear. We evaluated the impact of a VLCKD on weight loss and metabolic parameters and assessed weight loss predictors, including FGF21. VLCKD is a severely restricted diet (<800 Kcal/die), characterized by a very low carbohydrate intake (<50 g/day), 1.2-1.5 g protein/kg of ideal body weight and 15-30 g of fat/day. We treated 34 patients with obesity with a VLCKD for 45 days. Anthropometric parameters, body composition, and blood and urine chemistry were measured before and after treatment. We found a significant improvement in body weight and composition and most metabolic parameters. Circulating FGF21 decreased significantly after the VLCKD [194.0 (137.6-284.6) to 167.8 (90.9-281.5) p < 0.001] and greater weight loss was predicted by lower baseline FGF21 (Beta = -0.410; p = 0.012), male sex (Beta = 0.472; p = 0.011), and central obesity (Beta = 0.481; p = 0.005). VLCKD is a safe and effective treatment for obesity and obesity related metabolic derangements. Men with central obesity and lower circulating FGF21 may benefit more than others in terms of weight loss obtained following this diet. Further studies investigating whether this is specific to this diet or to any caloric restriction are warranted.

The Antioxidant Potential of the Mediterranean Diet as a Predictor of Weight Loss after a Very Low-Calorie Ketogenic Diet (VLCKD) in Women with Overweight and Obesity.

Obesity involves a chronic state of low-grade inflammation, which is linked to the development of several comorbidities. Recently, the very low-calorie ketogenic diet (VLCKD) has gained great interest in the treatment of obesity, almost ousting the ancient and healthy Mediterranean diet (MD). However, because these dietary regimens exploit different pathophysiological mechanisms, we hypothesize that adherence to the MD may play a role in determining the efficacy of the VLCKD. We enrolled 318 women (age 38.84 ± 14.37 years; BMI 35.75 ± 5.18 kg/m²) and assessed their anthropometric parameters, body compositions, and adherence to the MD (with the PREvención con DIetaMEDiterránea (PREDIMED) questionnaire) at baseline. The anthropometric parameters and body composition were repeated at the end of the VLCKD. At the end of the VLCKD, the women with high adherence to the MD achieved the best results in terms of weight loss and improved body composition. Specifically, the women who were above the median of fat mass (FM)% reduction had the best MD pattern, characterized by a higher consumption of extra virgin olive oil (EVOO), fruits, vegetables, and red wine, as well as a higher adherence to the MD than the women who were below the same median. In a multiple regression analysis, the PREDIMED score was the main predictor of the FM% reduction score and came in first, followed by fruit, EVOO, and glasses of wine, in predicting the percentage reduction in FM. A PREDIMED score value of &gt; 5 could serve as a threshold to identify patients who are more likely to lose FM at the end of the VLCKD. In conclusion, high adherence to the MD resulted in higher VLCKD efficacy. This could be due to the antioxidant and anti-inflammatory properties of the MD, which are capable of establishing a metabolic set-up that is favorable to the onset of more effective ketosis.