Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study

Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings

Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study

BACKGROUND: Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. Since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. Ketone bodies that are produced during fasting diets (FDs) and ketogenic diets (KDs) are an alternative and presumably more efficient energy source for the brain. Studies on mice with experimental autoimmune encephalomyelitis showed beneficial effects of KDs and FDs on disease progression, disability, cognition and inflammatory markers. However, clinical evidence on these diets is scarce. In the clinical study protocol presented here, we investigate whether a KD and a FD are superior to a standard diet (SD) in terms of therapeutic effects and disease progression. METHODS: This study is a single-center, randomized, controlled, parallel-group study. One hundred and eleven patients with relapsing-remitting MS with current disease activity and stable immunomodulatory therapy or no disease-modifying therapy will be randomized to one of three 18-month dietary interventions: a KD with a restricted carbohydrate intake of 20-40 g/day; a FD with a 7-day fast every 6 months and 14-h daily intermittent fasting in between; and a fat-modified SD as recommended by the German Nutrition Society. The primary outcome measure is the number of new T2-weighted MRI lesions after 18 months. Secondary endpoints are safety, changes in relapse rate, disability progression, fatigue, depression, cognition, quality of life, changes of gut microbiome as well as markers of inflammation, oxidative stress and autophagy. Safety and feasibility will also be assessed. DISCUSSION: Preclinical data suggest that a KD and a FD may modulate immunity, reduce disease severity and promote remyelination in the mouse model of MS. However, clinical evidence is lacking. This study is the first clinical study investigating the effects of a KD and a FD on disease progression of MS

Differences Between Omnivores and Vegetarians in Personality Profiles, Values, and Empathy: A Systematic Review

Numerous medical studies have documented vegetarian diets as having various health benefits. Studies have also compared vegetarians with other dietary groups from a socio-psychological perspective. The objective of this review is to investigate the differences between vegetarians and omnivores in terms of their personality profiles, values, and empathy skills. A search was conducted across three electronic databases. Non-randomized, observational, cross-sectional, and cohort studies were eligible. Outcomes provided information about the differences between the above-mentioned dietary groups regarding their personality profiles, values, and empathy skills. A shortened version of the Newcastle-Ottawa Scale was used to assess the risk of bias for the included studies. Of the 2,513 different studies found, 25 (total number of participants n = 23,589) were ultimately included. These studies indicate that vegetarians significantly differ from omnivores in their personalities, values, and ability to be empathetic. Omnivorism is associated with an increased orientation toward social dominance, greater right-wing authoritarianism, and, in line with this, a stronger tendency to be prejudiced. Vegetarianism is associated with greater openness and empathy. The values of vegetarians are based more on universalism, hedonism, stimulation, and self-direction, whereas the values of omnivores are based more on the idea of power. To answer a narrowly defined and clear question, issues such as animal ethics, animal rights, and environmental protection are not considered in this review. The findings of this review, showing marked differences in personality correlating to the choice of diet and the increasing influence of plant-based diets on a global level, indicate that further studies about vegetarianism are warranted

Significance of Medicinal Mushrooms in Integrative Oncology: A Narrative Review

Medicinal mushrooms are widely used in East Asia for the treatment of various diseases, especially in complementary cancer care. While there is a growing interest in medicinal mushrooms in Western countries and an increasing number of pre-clinical studies indicate distinct anti-cancer and regenerative properties, little is known about their potential relevance for clinical practice. This review aims to provide an overview of the clinical evidence, significance and potential role of medicinal mushrooms in complementary cancer care. Scientific databases for (randomized) controlled clinical trials evaluating whole spectrum formulations of medicinal mushrooms (mushroom powder and mushroom extracts) in cancer patients during and/or after conventional oncological treatment were searched. Eight studies met our inclusion criteria (eight randomized controlled trials, one controlled clinical trial). The medicinal mushrooms investigated were Agaricus sylvaticus (two trials), Agaricus blazei murill (two trials), Antrodia cinnamomea (one trial), Coriolus versicolor (one trial) and Ganoderma lucidum (three trials); all were compared to placebo and administered orally. A variety of cancer entities, outcomes and treatment durations were observed. Study results suggested beneficial effects of medicinal mushrooms, particularly quality of life and reduction of adverse effects of conventional therapies. Also, positive effects on antitumor activity and immunomodulation were reported, e.g., an increased activity of natural killer cells. In addition, results might suggest a longer survival of cancer patients receiving mushroom preparations, although in most studies this was not significant when compared to placebo. Adverse events of treatment with medicinal mushrooms were poorly reported; gastrointestinal reactions and a decrease in platelet cell count occurred in some cases. The methodological quality of most studies was generally unsatisfying and most results were insufficiently reported in several respects. Medicinal mushrooms may have a therapeutic potential for cancer patients during and after conventional oncological care with regards to quality of life, reduction of adverse effects of conventional care and possibly other surrogate parameters like immune function. There is an urgent need to investigate the safety and possible interactions of medicinal mushrooms. High-quality clinical research is warranted in order to clarify the potential of medicinal mushrooms in cancer therapy

Post Hoc Analysis of a Randomized Controlled Trial on Fasting and Plant-Based Diet in Rheumatoid Arthritis (NutriFast): Nutritional Supply and Impact on Dietary Behavior

This study aimed at comparing the nutrient supply and dietary behaviors during a plant-based diet (PBD) combined with time-restricted eating (TRE) to standard dietary recommendations in rheumatoid arthritis patients. In this open-label, randomized, controlled clinical trial, patients were assigned to either a 7-day fast followed by an 11-week PBD including TRE (A) or a 12-week anti-inflammatory diet following official German guidelines (German Nutrition Society, DGE) (B). Dietary habits were assessed by 3-day food records at weeks -1, 4 and 9 and food frequency questionnaires. 41 out of 53 participants were included in a post-hoc per protocol analysis. Both groups had similar energy, carbohydrate, sugar, fiber and protein intake at week 4. Group A consumed significantly less total saturated fat than group B (15.9 +/- 7.7 vs. 23.2 +/- 10.3 g/day; p = 0.02). Regarding micronutrients, group B consumed more vitamin A, B-12, D, riboflavin and calcium (each p <= 0.02). Zinc and calcium were below recommended intakes in both groups. Cluster analysis did not show clear group allocation after three months. Hence, dietary counselling for a PBD combined with TRE compared to a standard anti-inflammatory diet does not seem to lead to two different dietary clusters, i.e., actual different dietary behaviors as expected. Larger confirmatory studies are warranted to further define dietary recommendations for RA

LRRK2 transport is regulated by its novel interacting partner Rab32

Leucine-rich repeat kinase 2 (LRRK2) is a multi-domain 280 kDa protein that is linked to Parkinson's disease (PD). Mutations especially in the GTPase and kinase domains of LRRK2 are the most common causes of heritable PD and are also found in sporadic forms of PD. Although the cellular function of LRRK2 is largely unknown there is increasing evidence that these mutations cause cell death due to autophagic dysfunction and mitochondrial damage. Here, we demonstrate a novel mechanism of LRRK2 binding and transport, which involves the small GTPases Rab32 and Rab38. Rab32 and its closest homologue Rab38 are known to organize the trans-Golgi network and transport of key enzymes in melanogenesis, whereas their function in non-melanogenic cells is still not well understood. Cellular processes such as autophagy, mitochondrial dynamics, phagocytosis or inflammatory processes in the brain have previously been linked to Rab32. Here, we demonstrate that Rab32 and Rab38, but no other GTPase tested, directly interact with LRRK2. GFP-Trap analyses confirmed the interaction of Rab32 with the endogenous LRRK2. In yeast two-hybrid experiments we identified a predicted coiled-coil motif containing region within the aminoterminus of LRRK2 as the possible interacting domain. Fluorescence microscopy demonstrated a co-localization of Rab32 and LRRK2 at recycling endosomes and transport vesicles, while overexpression of a constitutively active mutant of Rab32 led to an increased co-localization with Rab7/9 positive perinuclear late endosomes/MVBs. Subcellular fractionation experiments supported the novel role of Rab32 in LRRK2 late endosomal transport and sorting in the cell. Thus, Rab32 may regulate the physiological functions of LRRK2

Yoga in school sports improves functioning of autonomic nervous system in young adults: A non-randomized controlled pilot study

Background Yoga in school is a beneficial tool to promote the good health and well-being of students by changing the way they react to stress. The positive effects of yoga—taught in schools—on children, youth and young adults have been demonstrated in former studies using mostly subjective psychometric data. Aim The present trial aims to evaluate the potential effects of yoga on autonomic regulation in young adults by analyzing heart rate variability (HRV). Methods This study is a non-randomized, explorative, two-arm-pilot study with an active control group. Fourteen healthy young adults took part in a 10-week yoga program (90 min once a week) in school and were compared to a control group of 11 students who participated in conventional school sports (90 min once a week over 10 weeks). 24-hour electrocardiograms (ECGs) were recorded at baseline and following the 10-week intervention. From 20-minute of nocturnal sleep phases, HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (such as symbolic dynamics and Poincaré plot analysis). Analyses of variance (ANOVA) followed by t-tests as post-hoc tests estimating both statistical significance and effect size were used to compare pre-post-intervention for the two groups. Results The statistical analysis of the interaction effects did not reveal a significant group and time interaction for the individual nocturnal HRV indices. Almost all indices revealed medium and large effects regarding the time main effects. The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. Conclusion In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system

The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study

Background This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. Methods In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A;n = 18) or vice versa (group B;n = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. Results The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. Conclusion STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. Trial registration This trial was registered at clinicaltrials.gov: NCT01954836

Effects of yoga and mindfulness practices on the autonomous nervous system in primary school children: A non-randomised controlled study

Objectives: The present study examined the effects of a yoga and mindfulness-based programme on the autonomic nervous system of primary school children by using heart rate variability parameters. Design: A two-arm non-randomised controlled trial compared an integrated yoga and mindfulness-based programme (16 weeks) to conventional primary school lessons. Setting: Primary school classrooms and conference rooms. Interventions: Participants were allocated to a 16-week integrated yoga-based programme or conventional school lessons. A subgroup was randomised to receive 24h electrocardiogram-recordings. Main outcome measures: Heart rate variability indices were measured, both linear (time and frequency domain) and non-linear (symbolic dynamics, compression entropy), calculated from 30-minute extracts of Holterelectrocardiogram-recordings. Assessments were conducted at baseline and at the end of intervention. Results: 40 participants (42.5% female) were included into the analysis of HRV. No significant changes in heart rate variability parameters were observed between the groups after 16 weeks. In the intervention group, a trend towards increased parasympathetic activity could be seen over time, although not significantly enhanced compared to the control group. Conclusion: Results obtained here do not clearly show that children in German primary school settings benefit from an integrated yoga-based intervention. However, exploratory post-hoc analyses point interestingly to an increased nocturnal parasympathetic activity in the intervention group. Further studies are required with highquality study designs, larger sample sizes and longer-term follow-ups

Faking like a woman? Towards an interpretative theorization of sexual pleasure.

This article explores the possibility of developing a feminist approach to gendered and sexual embodiment which is rooted in the pragmatist/interactionist tradition derived from G.H. Mead, but which in turn develops this perspective by inflecting it through more recent feminist thinking. In so doing we seek to rebalance some of the rather abstract work on gender and embodiment by focusing on an instance of 'heterosexual' everyday/night life - the production of the female orgasm. Through engaging with feminist and interactionist work, we develop an approach to embodied sexual pleasure that emphasizes the sociality of sexual practices and of reflexive sexual selves. We argue that sexual practices and experiences must be understood in social context, taking account of the situatedness of sex as well as wider socio-cultural processes the production of sexual desire and sexual pleasure (or their non-production) always entails interpretive, interactional processes