Hit or Miss:The New Cholesterol Targets

Robert DuBroff, Aseem Malhotra, Michel de Lorgeril

Drug treatment to reduce cholesterol to new target levels is now recommended in four moderate to high-risk patient populations: patients who have already sustained a cardiovascular event, adult diabetic patients, individuals with low density lipoprotein cholesterol levels ≥190mg/ dL and individuals with an estimated 10-year cardiovascular risk ≥7.5%. Achieving these cholesterol target levels did not confer any additional benefit in a systematic review of 35 randomised controlled trials. Recommending cholesterol lowering treatment based on estimated cardiovascular risk fails to identify many high-risk patients and may lead to unnecessary treatment of low-risk individuals. The negative results of numerous cholesterol lowering randomised controlled trials call into question the validity of using low density lipoprotein cholesterol as a surrogate target for the prevention of cardiovascular disease.

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Treating binge eating and food addiction symptoms with low-carbohydrate Ketogenic diets: a case series

Matthew Carmen, Debra Lynn Safer, Laura R. Saslow, Tro Kalayjian, Ashley E. Mason, Eric C. Westman and Shebani Sethi Dalai

Report on the feasibility of a low-carbohydrate ketogenic diet initiated by three patients
(age 54, 34, and 63) with obesity (average BMI 43.5 kg/m2) with comorbid binge eating and food addiction
symptoms. All patients tolerated following the ketogenic diet (macronutrient proportion 10% carbohydrate, 30%
protein, and 60% fat; at least 5040 kJ) for the prescribed period (e.g., 6–7 months) and none reported any major
adverse effects.

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Impact Of Ketogenic Diet On Athletes: Current Insights

McSwiney FT, Doyle L, Plews DJ, Zinn C

The impact of a ketogenic diet (KD) (<50 g/d carbohydrate, >75% fat) on athletic performance has sparked much interest and self-experimentation in the past 3–4 years. Evidence shows 3–4-week adaptations to a KD in endurance-trained athletes were associated with maintenance of moderate (46–63% VO2max) and vigorous intensity (64–90% VO2max) endurance exercise

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Dietary fat guidelines have no evidence base: where next for public health nutritional advice?

Zoe Harcombe, PhD

Dietary fat guidelines have prevailed for almost 40 years. The evidence base at the time of their introduction has been examined for the first time and found lacking. Evidence currently available provides no additional support. Public health opinion differed when the guidelines were introduced. Opposition to the guidelines is becoming more strident. Substantial increases in diet-related illness over the past four decades, particularly obesity and type 2 diabetes, indicate that a review of dietary advice is warranted.

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Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-year Non-randomized Clinical Trial

Shaminie J. Athinarayanan, Rebecca N. Adams, Sarah J. Hallberg, Amy L. McKenzie, Nasir H. Bhanpuri, Wayne W. Campbell, Jeff S. Volek, Stephen D. Phinney, James P. McCarter

An open label, non-randomized, controlled study with 262 and 87 participants with T2D were enrolled in the CCI and usual care (UC) groups, respectively.  Studies on long-term sustainability of low-carbohydrate approaches to treat diabetes are limited. The aim was to assess the effects of a continuous care intervention (CCI) on retention, glycemic control, weight, body composition, cardiovascular, liver, kidney, thyroid, inflammatory markers, diabetes medication usage and disease outcomes at 2 years in adults with type 2 diabetes (T2D).

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A low-carbohydrate survey: Evidence for sustainable metabolic syndrome reversal

Mark T. Cucuzzella, Justin Tondt, Nancy E. Dockter, Laura Saslow, Thomas R. Wood

Metabolic syndrome has become a significant problem, with the American Diabetes Association estimating the cost of diabetes and pre-diabetes in the United States alone to be $322 billion per year. Numerous clinical trials have demonstrated the efficacy of low-carbohydrate diets in reversing metabolic syndrome and its associated disorders.

This study was designed to examine how voluntary adherents to a low-carbohydrate diet rate its effectiveness and sustainability using an online survey.

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A clinician’s guide to inpatient low carbohydrate diets for remission of type 2 diabetes : toward a standard of care protocol

Mark Cucuzzella, Adele Hite, Kaitlyn Patterson, Laura Saslow, Rory Heath

Type 2 diabetes (T2DM) is most often treated as a chronic progressive condition. However, both clinical experience and scientific studies have shown that remission indicated by a normalizing of blood glucose levels and safe medication reduction through lifestyle change should be considered an achievable clinical outcome for patients with T2DM. Dietary interventions that include therapeutic levels of carbohydrate reduction can be used by clinicians to help patients reach this goal, as evidenced by clinical experience and clinical trials; however, many clinicians and allied healthcare providers have not been trained in how to administer these therapies.

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LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature

Michel de Lorgeril, David M Diamond, Rokuro Hama, Tomohito Hamazaki, Björn Hammarskjöld, Niamh Hynes, Malcolm Kendrick, Peter H Langsjoen, Luca Mascitelli, Kilmer S McCully, Harumi Okuyama ORCID Icon, Paul J Rosch, Tore Schersten, Sherif Sultan & Ralf Sundberg

For half a century, a high level of total cholesterol (TC) or low-density lipoprotein cholesterol (LDL-C) has been considered to be the major cause of atherosclerosis and cardiovascular disease (CVD), and statin treatment has been widely promoted for cardiovascular prevention. However, there is an increasing understanding that the mechanisms are more complicated and that statin treatment, in particular when used as primary prevention, is of doubtful benefit.

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Type 1 diabetes mellitus successfully managed with the paleolithic ketogenic diet

Csaba Tóth, Zsófia Clemens

Diabetic patients are, generally, recommended to follow a diet that is low in fat and high in carbohydrates.  Clinical studies, conversely, showed metabolic benefits conferred by carbohydrate-restricted diets including the ketogenic diet and the paleolithic diet in type 2 diabetes.  Much less data on the use of low carbohydrate diets in type 1 diabetes (T1DM) are available.  Two studies by Nielsen et al. showed that a low carbohydrate diet lowers the need for insulin as well as the number of hypoglycemic episodes in T1DM .  It was also suggested that a low carbohydrate diet is sustainable on the long-term

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Pre-operative Very Low Calorie Ketogenic Diet (VLCKD) vs. Very Low Calorie Diet (VLCD): Surgical Impact

Alice Albanese, L. Prevedello, M. Markovich, L. Busetto, R. Vettor, M. Foletto

Pre-operative diet may play an important role as far as patients’ fitness for surgery, post-operative outcomes, and successful weight loss.  Our aim was to compare surgical outcome and weight loss in two groups of patients who were offered two different pre-operative kinds of diet: very low calorie diet (VLCD) and very low calorie ketogenic diet (VLCKD).

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Impact of a ketogenic diet intervention during radiotherapy on body composition: I. Initial clinical experience with six prospectively studied patients

Rainer J. Klement; Reinhart A. Sweeney

Single arm with 6 participants:  Our data lend support to the hypothesis that KDs administered as supportive measures during standard therapy are safe and might be helpful in preservation of muscle mass. There was consensus that the KD was satiating and weight loss occurred in all patients, although this was only significant in two patients. Our data indicate that weight loss was mainly due to fat mass loss with concurrent preservation of muscle mass. Overall quality of life remained fairly stable, and all subjects reported feeling good on the diet. Tumor regression occurred as expected in five patients with early stage disease

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Anti-Oxidant and Anti-Inflammatory Activity of Ketogenic Diet: New Perspectives for Neuroprotection in Alzheimer’s Disease

Alessandro Pinto; Alessio Bonucci; Elisa Maggi; Mariangela Corsi; Rita Businaro

Review:  The few studies conducted on humans available so far are based on a pre/post design but without a reference control group and without randomization.  Of particular interest were the RCTs that correlated the introduction of KD to an improvement of verbal receptive vocabulary and of reaction time in children affected by epilepsy, as well as an improvement in attention and memory in patients affected by multiple sclerosis.  The results demonstrated causal evidence and stressed the need to increase the number of studies to demonstrate that 4:1 KD induces a cognitive improvement in neurological diseases

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Modified ketogenic diet in lymphoma: A case series in the Veteran Affairs Pittsburgh Healthcare System

Jocelyn Tan-Shalaby; Roby Antony Thomas; Jennifer Carrick; Andrew D. Liman; Vida Almario Passero; Arisha Patel; Jenna Shields

Single arm prospective with 3 participants:  Ketogenic diets in human lymphomas appears well tolerated and can improve symptoms, quality of life, and limit tumor growth. Ketogenic diets may reverse the weight loss seen in terminal cancer patients with cachexia

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Modified Atkins diet in advanced malignancies – final results of a safety and feasibility trial within the Veterans Affairs Pittsburgh Healthcare System

Jocelyn L. Tan-Shalaby; Jennifer Carrick; Krystal Edinger; Dana Genovese; Andrew D. Liman; Vida A. Passero; Rashmikant B. Shah

Single arm prospective with with 17 participants:  Dysfunctional mitochondrial processes limit malignant cells ability to use energy from fatty acids and ketones. Animal studies using ketogenic diets for cancer show encouraging results. We tested the diet’s safety and feasibility in cancer patients across a broad variety of solid tumors.

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Isocaloric fructose restriction and metabolic improvement in children with obesity and metabolic syndrome

Robert H. Lustig; Kathleen Mulligan; Susan M. Noworolsk;i Viva W. Tai; Michael J. Wen; Ayca Erkin‐Cakmak; Alejandro Gugliucci; Jean‐Marc Schwarz

Single arm prospective with 27 participants from 2 specific, at risk, ethnic groups:  This study argues that the health detriments of sugar, and fructose specifically, are independent of its caloric value or effects on weight. Further studies will be required to determine whether sugar restriction alone can impact metabolic syndrome in adults and whether such effects are short‐lived or long‐term.

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Management of Glioblastoma Multiforme in a Patient Treated With Ketogenic Metabolic Therapy and Modified Standard of Care: A 24-Month Follow-Up

Ahmed M. A. Elsakka; Mohamed Abdel Bary; Eman Abdelzaher; Mostafa Elnaggar; Miriam Kalamian; Purna Mukherjee; Thomas N. Seyfried

Case Report:  A press-pulse therapeutic strategy was implemented to target glucose and glutamine availability in a 38-year-old GBM patient using a modified SOC and KMT. As less than 20% of younger adults generally survive beyond 24 months with GBM, it is possible that the response observed in this case resulted in part from KMT and the modified SOC. The patient is now 40 years old and remains in excellent health with no noticeable neurological issues (Karnofsky Score, 100%) after 24 months of treatment.

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Efficacy of Metabolically Supported Chemotherapy Combined with Ketogenic Diet, Hyperthermia, and Hyperbaric Oxygen Therapy for Stage IV Triple-Negative Breast Cancer

Mehmet Salih İyikesici; Abdul Kadir Slocum; Ayshe Slocum; Ferhan Bulent Berkarda; Miriam Kalamian; Thomas N. Seyfried

Case Report:  We have described a complete response to MSCT, KD, HT, and HBOT in a 29-year-old woman with stage IV (T4N3M1) TNBC that had metastasized to the lymph nodes, liver, and abdomen. Despite the advanced stage of this disease, the therapeutic strategy of combining MSCT, KD, HT, and HBOT achieved a clinical and radiological complete response in this patient within four months.  The treatment regimen was continued for an additional two months when pCR was further documented in tissue following her mastectomy.

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Patient with Recurrent Glioblastoma Responding Favorably to Ketogenic Diet Combined with Intranasal Delivery of Perillyl Alcohol: A Case Report and Literature Review

Juliana Guimarães Santos; Wanise Maria Souza Da Cruz; Axel H. Schönthal; Marcela D'alincourt Salazar; Cristina Asvolinsque Pantaleão Fontes; Thereza Quirico-Santos; Clovis Orlando da Fonseca

Case Report:  After 3 months of a Ketogenic Diet combined with intra-nasal POH therapy led to a marked reduction of the lesion and significant clinical improvement. Tumor growth was halted during the 3-month treatment phase.

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β-Hydroxybutyrate Deactivates Neutrophil NLRP3 Inflammasome to Relieve Gout Flares

Emily L. Goldberg; Jennifer L. Asher; Ryan D. Molony; Albert C. Shaw; Caroline J. Zeiss; Chao Wang; Ludmilla A. Morozova-Roche; Raimund I. Herzog; Akiko Iwasaki; Vishwa Deep Dixit

Rat study:  Aging and lipotoxicity are two major risk factors for gout that are linked by the activation of the NLRP3 inflammasome. Neutrophil-mediated production of interleukin-1β (IL-1β) drives gouty flares that cause joint destruction, intense pain, and fever…… Collectively, our studies show that BHB, a known alternate metabolic fuel, is also an anti-inflammatory molecule that may serve as a treatment for gout.

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Fasting Lipoprotein and Postprandial Triacylglycerol Responses to a Lowcarbohydrate Diet Supplemented With n-3 Fatty Acids

Jeff S. Volek, PhD, RD; Ana L. Gómez , MS; William J. Kraemer , PhD

Single arm prospective with 10 Participants:  A hypocaloric low-carbohydrate diet rich in MUFA and supplemented with n-3 fatty acids significantly reduced postabsorptive and postprandial TG in men that were not hypertriglyceridemic as a group before the diet.  This may be viewed as a clinically significant positive adaptation in terms of cardiovascular risk status.

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Effect of 6-month Adherence to a Very Low Carbohydrate Diet Program

Eric C Westman, MD, MHS; William S Yancy, MD; Joel S Edman, DSc; Keith F Tomlin; Christine E Perkins, MSW

Single arm prospective with 51 participants:  In these subjects, the mean body weight decreased 10.3% +/- 5.9% from baseline to 6 months. The mean percentage of body weight that was fat decreased 2.9% +/- 3.2% from baseline to 6 months. Serum total cholesterol level decreased 11 +/- 26 mg/dL, low-density lipoprotein cholesterol level decreased 10 +/- 25 mg/dL, triglyceride level decreased 56 +/- 45 mg/dL, high-density lipoprotein (HDL) cholesterol level increased 10 +/- 8 mg/dL, and the cholesterol/HDL cholesterol ratio decreased 0.9 +/- 0.6 units. A very low carbohydrate diet program led to sustained weight loss during a 6-month period.

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Body Composition and Hormonal Responses to a Carbohydrate-restricted Diet

Jeff S. Volek; Matthew J. Sharman; Dawn M. Love; Neva G. Avery; Ana L. G[oacute]mez; Timothy P. Scheett; William J. Kraemer

Single arm propective with 12 participants:  Authors conclude that a carbohydrate-restricted diet resulted in a significant reduction in fat mass and a concomitant increase in lean body mass in normal-weight men, which may be partially mediated by the reduction in circulating insulin concentrations.

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An Isoenergetic Very Low Carbohydrate Diet Improves Serum HDL Cholesterol and Triacylglycerol Concentrations, the Total Cholesterol to HDL Cholesterol Ratio and Postprandial Pipemic Responses Compared With a Low Fat Diet in Normal Weight, Normolipidemic Women

Jeff S. Volek; Matthew J. Sharman; Ana L. Gómez; Timothy P. Scheett; William J. Kraemer

Ramdomized crossover with 10 participants:  In normal weight, normolipidemic women, a short-term very low carbohydrate diet modestly increased LDL-C, yet there were favorable effects on cardiovascular disease risk status by virtue of a relatively larger increase in HDL-C and a decrease in fasting and postprandial triaclyglycerols.

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