scholarly journals VLCKD: a real time safety study in obesity

2022 ◽  
Vol 20 (1) ◽  
Author(s):  
Luigi Barrea ◽  
Ludovica Verde ◽  
Claudia Vetrani ◽  
Francesca Marino ◽  
Sara Aprano ◽  
...  

Abstract Background Very Low-Calorie Ketogenic Diet (VLCKD) is currently a promising approach for the treatment of obesity. However, little is known about the side effects since most of the studies reporting them were carried out in normal weight subjects following Ketogenic Diet for other purposes than obesity. Thus, the aims of the study were: (1) to investigate the safety of VLCKD in subjects with obesity; (2) if VLCKD-related side effects could have an impact on its efficacy. Methods In this prospective study we consecutively enrolled 106 subjects with obesity (12 males and 94 females, BMI 34.98 ± 5.43 kg/m2) that underwent to VLCKD. In all subjects we recorded side effects at the end of ketogenic phase and assessed anthropometric parameters at the baseline and at the end of ketogenic phase. In a subgroup of 25 subjects, we also assessed biochemical parameters. Results No serious side effects occurred in our population and those that did occur were clinically mild and did not lead to discontinuation of the dietary protocol as they could be easily managed by healthcare professionals or often resolved spontaneously. Nine (8.5%) subjects stopped VLCKD before the end of the protocol for the following reasons: 2 (1.9%) due to palatability and 7 (6.1%) due to excessive costs. Finally, there were no differences in terms of weight loss percentage (13.5 ± 10.9% vs 18.2 ± 8.9%; p = 0.318) in subjects that developed side effects and subjects that did not developed side effects. Conclusion Our study demonstrated that VLCKD is a promising, safe and effective therapeutic tool for people with obesity. Despite common misgivings, side effects are mild, transient and can be prevented and managed by adhering to the appropriate indications and contraindications for VLCKD, following well-organized and standardized protocols and performing adequate clinical and laboratory monitoring.

Obesity Facts ◽  
2021 ◽  
Vol 14 (2) ◽  
pp. 222-245
Author(s):  
Giovanna Muscogiuri ◽  
Marwan El Ghoch ◽  
Annamaria Colao ◽  
Maria Hassapidou ◽  
Volkan Yumuk ◽  
...  

<b><i>Background:</i></b> The very low-calorie ketogenic diet (VLCKD) has been recently proposed as an appealing nutritional strategy for obesity management. The VLCKD is characterized by a low carbohydrate content (&#x3c;50 g/day), 1–1.5 g of protein/kg of ideal body weight, 15–30 g of fat/day, and a daily intake of about 500–800 calories. <b><i>Objectives:</i></b> The aim of the current document is to suggest a common protocol for VLCKD and to summarize the existing literature on its efficacy in weight management and weight-related comorbidities, as well as the possible side effects. <b><i>Methods:</i></b> This document has been prepared in adherence with Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Literature searches, study selection, methodology development, and quality appraisal were performed independently by 2 authors and the data were collated by means of a meta-analysis and narrative synthesis. <b><i>Results:</i></b> Of the 645 articles retrieved, 15 studies met the inclusion criteria and were reviewed, revealing 4 main findings. First, the VLCKD was shown to result in a significant weight loss in the short, intermediate, and long terms and improvement in body composition parameters as well as glycemic and lipid profiles. Second, when compared with other weight loss interventions of the same duration, the VLCKD showed a major effect on reduction of body weight, fat mass, waist circumference, total cholesterol and triglyceridemia as well as improved insulin resistance. Third, although the VLCKD also resulted in a significant reduction of glycemia, HbA1c, and LDL cholesterol, these changes were similar to those obtained with other weight loss interventions. Finally, the VLCKD can be considered a safe nutritional approach under a health professional’s supervision since the most common side effects are usually clinically mild and easily to manage and recovery is often spontaneous. <b><i>Conclusions:</i></b> The VLCKD can be recommended as an effective dietary treatment for individuals with obesity after considering potential contra-indications and keeping in mind that any dietary treatment has to be personalized. <b><i>Prospero Registry:</i></b> The assessment of the efficacy of VLCKD on body weight, body composition, glycemic and lipid parameters in overweight and obese subjects: a meta-analysis (CRD42020205189).


2021 ◽  
pp. 205141582110166
Author(s):  
Timothy P Napier-Hemy ◽  
Oladapo Feyisetan ◽  
Heather Stewart ◽  
Alaa Chamsin ◽  
Michael S Floyd ◽  
...  

Objectives: To determine whether administration of single dose prophylactic intravenous gentamicin prior to intravesical injection of botulinum toxin type A (BoNT-A) is associated with adverse extravesical neuromuscular effects in idiopathic overactive bladder syndrome. Patients and methods: A retrospective analysis of 220 consecutive idiopathic overactive bladder patients following sedation-free flexible cystoscopic injection of intravesical BoNT-A. All patients received a single dose of intravenous gentamicin (160 mg) followed by 100-200 IU of BoNT-A. They were followed up at intervals to determine whether they had experienced any adverse extravesical neuromuscular side effects. Results: None of our patients developed adverse extravesical neuromuscular side effects from intravesical botulinum injections with concomitant administration of intravenous gentamicin. Conclusion: Single dose intravenous gentamicin is safe to use as a prophylaxis for intravesical BoNT-A injections of 200 IU or below in idiopathic overactive bladder patients. Level of evidence: Not applicable.


2009 ◽  
Vol 45 (2) ◽  
pp. 303-312
Author(s):  
Daliana Maria Berenice de Oliveira Souza ◽  
Suellen Cristiane Medeiros de Lima ◽  
Almária Mariz Batista ◽  
Maria Cleide Ribeiro Dantas de Carvalho

This work intended to analyze the advertising of medicines requiring medical prescription, divulged into three journals of the neurology and cardiology areas addressed to healthcare professionals. The analysis was based on current legislation, among other criteria, as well as specific literature. The presence of the following items was investigated: registration number, drug name, specific indications, contraindications; cautions and warnings; adverse reactions; possible side effects; posology; legibility of technical-scientific information and bibliographic references, phrases and/or expressions about the medication benefits, as compared to other drugs; safety warnings, healing promises and pictures of people smiling, and the quotations confirmation based on bibliographic references. Among the evaluated legal criteria, it was observed the absence of legibility in technical-scientific information in 85% of advertisements; absence of side effects in 23%; absence of cautions and warnings in 15%; of contraindications in 12.8%; of posology in 6.4%; of registration numbers in 2.7% and of the Common Brazilian Denomination/Common International Denomination (Denominação Comum Brasileira/Denominação Comum Internacional - DCB/DCI) in 0.6%. Out of 130 statements respecting advantages face to others drugs, 23.8% were not confirmed and out of 48 divulged safety messages, 41.7% could not be found in quoted references. The pictures of people smiling was a resource used in 42.2% of advertisements. Out of 1362 references analyzed, 19.7% were not found and 37.1% of quoted affirmations weren't confirmed.


2016 ◽  
Vol 14 (3) ◽  
pp. 286-294 ◽  
Author(s):  
Ippei Takeuchi ◽  
Manako Hanya ◽  
Junji Uno ◽  
Yuhei Amano ◽  
Keiko Fukai ◽  
...  

Author(s):  
Anastasia Garoufi ◽  
Evangelos E. Grammatikos ◽  
Anastasios Kollias ◽  
Emmanuel Grammatikos ◽  
George S. Stergiou ◽  
...  

AbstractBackground:Excess weight, unhealthy lifestyle habits and their sequelae have become a well-recognized public health problem in most countries. The objective of the study was to examine the relationship of adolescent overweight/obesity with behavioral habits and their association with blood pressure (BP) and lipid profile.Methods:Anthropometric parameters, lifestyle, BP and lipid profile of 736 adolescents were evaluated cross-sectionally. The classifications of normal weight, overweight and obese were based on BMI z-scores.Results:About 42.1% of adolescents were overweight/obese, 11.3% were smokers, 33.2% consumed alcohol and 34% reported low activity. Males began smoking earlier, consumed alcohol more often, exercised less and spent more screen time than females. Alcohol consumption was more prevalent among smokers and was associated with higher BP and dyslipidemia. Smokers exercised less intensely and had lower high density lipoprotein-cholesterol (HDL-C) than non-smokers. Obesity was a risk factor for higher BP and dyslipidemia. Longer screen time was associated with higher triglycerides, while intense physical activity with lower systolic BP.Conclusions:Obesity is related to an adverse lipid and BP profile during adolescence. Clustering of hazardous habits was observed, which is known to aggravate the cardiovascular risk.


Nutrients ◽  
2018 ◽  
Vol 10 (7) ◽  
pp. 932 ◽  
Author(s):  
Luciene Oliveira-de-Lira ◽  
Eduila Santos ◽  
Raphael de Souza ◽  
Rhowena Matos ◽  
Matilde Silva ◽  
...  

Fatty acid (FA) composition is a determinant of the physiological effects of dietary oils. This study investigated the effects of vegetable oil supplementation with different FA compositions on anthropometric and biochemical parameters in obese women on a hypocaloric diet with lifestyle modifications. Seventy-five women (body mass index, BMI, 30–39.9kg/m2) were randomized based on 8-week oil supplementation into four experimental groups: the coconut oil group (CoG, n = 18), the safflower oil group (SafG, n = 19), the chia oil group (ChG, n = 19), and the soybean oil placebo group (PG, n = 19). Pre- and post-supplementation weight, anthropometric parameters, and body fat (%BF), and lean mass percentages (%LM) were evaluated, along with biochemical parameters related to lipid and glycidemic profiles. In the anthropometric evaluation, the CoG showed greater weight loss (Δ% = −8.54 ± 2.38), and reduced BMI (absolute variation, Δabs = −2.86 ± 0.79), waist circumference (Δabs = −6.61 ± 0.85), waist-to-height ratio (Δabs = −0.041 ± 0.006), conicity index (Δabs = −0.03 ± 0.016), and %BF (Δabs = −2.78 ± 0.46), but increased %LM (Δabs = 2.61 ± 1.40) (p < 0.001). Moreover, the CoG showed a higher reduction in biochemical parameters of glycemia (Δabs = −24.71 ± 8.13) and glycated hemoglobin (Δabs = −0.86 ± 0.28) (p < 0.001). The ChG showed a higher reduction in cholesterol (Δabs = −45.36 ± 0.94), low-density lipoprotein cholesterol (LDLc; Δabs = −42.53 ± 22.65), and triglycerides (Δabs = −49.74 ± 26.3), but an increase in high-density lipoprotein cholesterol (HDLc; abs = 3.73 ± 1.24, p = 0.007). Coconut oil had a more pronounced effect on abdominal adiposity and glycidic profile, whereas chia oil had a higher effect on improving the lipid profile. Indeed, supplementation with different fatty acid compositions resulted in specific responses.


Author(s):  
A. G. Christina Bergqvist

There is great variability in how the ketogenic diet (KD) is implemented. Most of the differences are preference based. A consensus statement attempted to unify professional practices. The KD can be safely used in all ages, modified for specific dietary needs, and administered as food, formula, or intravenous alimentation. Effectiveness, compliance, and minimal side effects are achieved using a team-based, family-centered support structure. The KD is commonly initiated in an in-patient setting with a gradual advancement of the fat. Some centers still begin the KD with a brief fast. Out-patient initiation with slower advancement to a full diet can be challenging but safely executed. Time to determine response and duration of treatment in responders varies. Side effects are better understood and best managed proactively by monitoring, but cannot always be prevented and must be weighed with the benefit of continuing the therapy.


Medicina ◽  
2006 ◽  
Vol 43 (1) ◽  
pp. 10 ◽  
Author(s):  
Gražina Drąsutienė ◽  
Janina Tutkuvienė ◽  
Jolita Zakarevičienė ◽  
Diana Ramašauskaitė ◽  
Žaneta Kasilovskienė ◽  
...  

Objective. To evaluate changes in anthropometric and biochemical parameters in pregnancy and their dynamics during last two decades and to determine the association between anthropometric and biochemical parameters, their influence on fetal and neonatal development. Material and methods. In 1985–2005, anthropometric (height, body mass, weight gain during pregnancy, pelvic measurements, skinfold thicknesses, passive body mass) and biochemical (cholesterol, triglyceride, protein, and iron levels) parameters, their correlation, changes in pregnancy were examined; also the correlations between these parameters and neonatal body mass indices were evaluated. In 1986–1987, 383 pregnant women were examined, in 1998 – 130, and in 2003–2005 – 133. Results. During 20 years, the height of examined women increased on an average of 2.5 cm; they became thinner; body mass index decreased. The body composition became similar to “cylinder” shape due to decreased thickness of adipose tissue in the limbs. The dimensions of bony pelvis – external conjugate and bicristal diameters – decreased. Primiparous women became older (1995 – 22.5 years of age, 2004 – 27.6). At the beginning of investigation, the weight gain was on an average of 21.9% of body mass before pregnancy (13.3 kg) and at the end – 23.9% (14.2 kg). The values of anthropometric parameters vary in a consistent pattern during pregnancy: the lower body mass and body mass index at the beginning of pregnancy, the higher weight gain at the end of pregnancy. Blood serum levels of cholesterol, triglycerides, and especially iron were decreased during the study. Conclusions. An inverse correlation between body mass index and lipid metabolism in pregnancy was revealed: the higher body mass index was at the beginning of pregnancy, the lower increase in lipid concentration was during pregnancy. At the beginning of investigation as well as after 20 years, women with low body mass index showed the most significant anthropometric and lipid metabolic changes in pregnancy.


2020 ◽  
Vol 10 ◽  
Author(s):  
Raffaele Parrozzani ◽  
Giuseppe Lombardi ◽  
Edoardo Midena ◽  
Davide Londei ◽  
Marta Padovan ◽  
...  

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