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.

BackgroundFasting is beneficial in many diseases, including rheumatoid arthritis (RA), with lasting effects for up to 1 year. However, existing data dates back several decades before the introduction of modern therapeutic modalities.ObjectiveThis exploratory RCT compares the effects of a 7-day fast followed by a plant-based diet (PBD) to the effects of the dietary recommendations of the German society for nutrition (Deutsche Gesellschaft für Ernährung, DGE) on RA disease activity, cardiovascular (CV) risk factors, and well-being.MethodsIn this RCT we randomly assigned 53 RA patients to either a 7-day fast followed by an 11-week PBD or a 12-week standard DGE diet. The primary endpoint was the group change from baseline to 12 weeks on the Health Assessment Questionnaire Disability Index (HAQ-DI). Further outcomes included other disease activity scores, body composition, and quality of life.ResultsOf 53 RA patients enrolled, 50 participants (25 per group) completed the trial and were included into the per-protocol analysis. The primary endpoint was not statistically significant. However, HAQ-DI improved rapidly in the fasting group by day 7 and remained stable over 12 weeks (Δ-0.29, p = 0.001), while the DGE group improved later at 6 and 12 weeks (Δ-0.23, p = 0.032). DAS28 ameliorated in both groups by week 12 (Δ-0.97, p < 0.001 and Δ-1.14, p < 0.001; respectively), with 9 patients in the fasting but only 3 in the DGE group achieving ACR50 or higher. CV risk factors including weight improved stronger in the fasting group than in the DGE group (Δ-3.9 kg, p < 0.001 and Δ-0.7 kg, p = 0.146).ConclusionsCompared with a guideline-based anti-inflammatory diet, fasting followed by a plant-based diet showed no benefit in terms of function and disability after 12 weeks. Both dietary approaches had a positive effect on RA disease activity and cardiovascular risk factors in patients with RA.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03856190, identifier: NCT03856190.

BackgroundPrevious studies have shown beneficial effects of therapeutic fasting and plant-based dietary interventions on disease activity in patients with rheumatoid arthritis (RA) for a duration of up to 1 year. To date, the effects of such interventions on the gut microbiome and on modern diagnostic markers in patients with RA have not been studied. This trial aims to investigate the clinical effects of therapeutic fasting and a plant-based diet in patients with RA, additionally considering current immunological diagnostic tools and microbiome analyses.Methods/designThis trial is an open-label, single-centre, randomised, controlled, parallel-group clinical trial. We will randomly assign 84 patients with RA under a stable standard therapy to either (1) therapeutic fasting followed by a plant-based dietary intervention or (2) to a conventional nutritional counselling focusing on an anti-inflammatory dietary pattern according to the recommendations of the Deutsche Gesellschaft für Ernährung (German society for nutrition). Primary outcome parameter is the group difference from baseline to 12 weeks on the Health Assessment Questionnaire (HAQ). Other secondary outcomes include established clinical criteria for disease activity and treatment response in RA (Disease Activity Score 28, Simple Disease Activity Index, ACR-Response Criteria), changes in self-reported health and physical functional ability, mood, stress, quality of life, dietary behaviour via 3-day food records and a modified Food Frequency Questionnaire, body composition, changes in the gut microbiome, metabolomics and cytometric parameters. Outcomes will be assessed at baseline and day 7, after 6 weeks, 12 weeks and after 6 months.Ethics and disseminationEthical approval to process and analyse data, and to publish the results was obtained through the institutional review board of Charité-Universitätsmedizin Berlin. Results of this trial will be disseminated through peer-reviewed publications and scientific presentations.Trial registration numberNCT03856190.

Background: Religiously motivated Bahá'í fasting (BF) is a form of intermittent dry fasting celebrated by abstaining from food and drinks during daylight hours every year in March for 19 consecutive days.Aim: To test the safety and effects of BF on hydration, metabolism, and the circadian clock.Methods: Thirty-four healthy Bahá'í volunteers (15 women) participated in this prospective, exploratory cohort study. Laboratory examinations were carried out in four study visits: before fasting (V0), in the third week of fasting (V1) as well as 3 weeks (V3) and 3 months (V4) after fasting. Data collection included blood and urine samples, anthropometric measurements and bioelectrical impedance analysis. At V0 and V1, 24- and 12-hour urine and serum osmolality were measured. At V0–V2, alterations in the circadian clock phase were monitored in 16 participants. Our study was augmented by an additional survey with 144 healthy Bahá'í volunteers filling out questionnaires and with subgroups attending metabolic measurements (n = 11) and qualitative interviews (n = 13), the results of which will be published separately.Results: Exploratory data analysis revealed that serum osmolality (n = 34, p < 0.001) and 24-hour urine osmolality (n = 34, p = 0.003) decreased during daytime fasting but remained largely within the physiological range and returned to pre-fasting levels during night hours. BMI (body mass index), total body fat mass, and resting metabolic rate decreased during fasting (n = 34, p < 0.001), while body cell mass and body water appeared unchanged. The circadian phase estimated by transcript biomarkers of blood monocytes advanced by 1.1 h (n = 16, p < 0.005) during fasting and returned to pre-fasting values 3 weeks after fasting. Most observed changes were not detectable anymore 3 months after fasting.Conclusions: Results indicate that BF (Bahá'í fasting) is safe, has no negative effects on hydration, can improve fat metabolism and can cause transient phase shifts of circadian rhythms.Trial Registration:https://www.clinicaltrials.gov/, identifier: NCT03443739.

Background/objectives A few preliminary studies have documented the safety and feasibility of repeated short-term fasting in patients undergoing chemotherapy. However, there is a lack of data from larger randomized trials on the effects of short-term fasting on quality of life, reduction of side effects during chemotherapy, and a possible reduction of tumor progression. Moreover, no data is available on the effectiveness of fasting approaches compared to so-called healthy diets. We aim to investigate whether the potentially beneficial effects of short-term fasting can be confirmed in a larger randomized trial and can compare favorably to a plant-based wholefood diet. Methods This is a multicenter, randomized, controlled, two-armed interventional study with a parallel group assignment. One hundred fifty patients, including 120 breast cancer patients and 30 patients with ovarian cancer, are to be randomized to one of two nutritional interventions accompanying chemotherapy: (1) repeated short-term fasting with a maximum energy supply of 350–400 kcal on fasting days or (2) repeated short-term normocaloric plant-based diet with restriction of refined carbohydrates. The primary outcome is disease-related quality of life, as assessed by the functional assessment of the chronic illness therapy measurement system. Secondary outcomes include changes in the Hospital Anxiety and Depression Score and as well as frequency and severity of chemotherapy-induced side effects based on the Common Terminology Criteria of Adverse Events. Explorative analysis in a subpopulation will compare histological complete remissions in patients with neoadjuvant treatments. Discussion/planned outcomes Preclinical data and a small number of clinical studies suggest that repeated short-term fasting may reduce the side effects of chemotherapy, enhance quality of life, and eventually slow down tumor progression. Experimental research suggests that the effects of fasting may partly be caused by the restriction of animal protein and refined carbohydrates. This study is the first confirmatory, randomized controlled, clinical study, comparing the effects of short-term fasting to a short-term, plant-based, low-sugar diet during chemotherapy on quality of life and histological tumor remission. Trial registration ClinicalTrials.gov NCT03162289. Registered on 22 May 2017

Distress is a growing public health concern. In this three-armed randomized controlled trial, n = 102 adults with elevated stress levels and stress-related symptoms were randomly assigned to (1) “integrative” yoga classes which combined physical exercises, mindfulness training, and ethical/philosophical aspects of traditional yoga; to (2) Iyengar yoga classes which entailed primarily physical exercises; or to (3) mindfulness training without physical training. We hypothesized the synergistic effects of physical yoga exercises, mindfulness, and ethical/philosophical aspects. The primary outcome was the group difference on Cohen’s Perceived Stress Scale (PSS) after 12 weeks. Secondary outcomes included burnout, quality of life, physical complaints, depression, anxiety, mindfulness, interoceptive awareness, self-regulation, spirituality, mysticism, and posttraumatic stress. All outcomes were evaluated at baseline (V0), after 12 weeks (V1), and after 24 weeks (V2). A subset of participants took part in qualitative interviews. A lasting and clinically relevant stress reduction was observed within all groups (PSS ΔV0–V1Integrative Yoga = −6.69 ± 6.19; ΔV0–V1Iyengar Yoga = −6.00 ± 7.37; ΔV0–V1Mindfulness = −9.74 ± 7.80; all p < 0.00). Effect sizes were also statistically large at the end of the follow-up period (Cohen’s d Integrative Yoga = 1.41; d Iyengar Yoga = 1.37; d Mindfulness = 1.23). There were no significant group differences or evidence of relevant synergistic effects from combining mindfulness and physical yoga exercises. All three interventions were found to be equally effective methods of stress reduction. Their use in practice should be based on availability and patient preference.

Background: Time-restricted eating is a promising dietary strategy for weight loss, glucose and lipid metabolism improvements, and overall well-being. However, human studies demonstrated contradictory results for the restriction of food intake to the beginning (early TRE, eTRE) or to the end of the day (late TRE, lTRE) suggesting that more carefully controlled studies are needed.Objective: The aim of the ChronoFast trial study is to determine whether eTRE or lTRE is a better dietary approach to improve cardiometabolic health upon minimized calorie deficits and nearly stable body weight.Methods: Here, we present the study protocol of the randomized cross-over ChronoFast clinical trial comparing effects of 2 week eTRE (8:00 to 16:00 h) and lTRE (13:00 to 21:00 h) on insulin sensitivity and other glycemic traits, blood lipids, inflammation, and sleep quality in 30 women with overweight or obesity and increased risk of type 2 diabetes. To ensure timely compliance and unchanged dietary composition, and to minimize possible calorie deficits, real-time monitoring of dietary intake and body weight using a smartphone application, and extensive nutritional counseling are performed. Continuous glucose monitoring, oral glucose tolerance test, 24 h activity tracking, questionnaires, and gene expression analysis in adipose tissue and blood monocytes will be used for assessment of study outcomes.Discussion: The trial will determine whether eTRE or lTRE is more effective to improve cardiometabolic health, elucidate underlying mechanisms, and contribute to the development of recommendations for medical practice and the wider population.Clinical Trial Registration:www.ClinicalTrials.gov, Identifier [NCT04351672]

Background/Objective: Historically, fasting has been practiced not only for medical but also for religious reasons. Bahá’ís follow an annual religious intermittent dry fast of 19 days. We inquired into motivation behind and subjective health impacts of Bahá’í fasting. Methods: A convergent parallel mixed methods design was embedded in a clinical single arm observational study. Semi-structured individual interviews were conducted before (n = 7), during (n = 8), and after fasting (n = 8). Three months after the fasting period, two focus group interviews were conducted (n = 5/n = 3). A total of 146 Bahá’í volunteers answered an online survey at five time points before, during, and after fasting. Results: Fasting was found to play a central role for the religiosity of interviewees, implying changes in daily structures, spending time alone, engaging in religious practices, and experiencing social belonging. Results show an increase in mindfulness and well-being, which were accompanied by behavioural changes and experiences of self-efficacy and inner freedom. Survey scores point to an increase in mindfulness and well-being during fasting, while stress, anxiety, and fatigue decreased. Mindfulness remained elevated even three months after the fast. Conclusion: Bahá’í fasting seems to enhance participants’ mindfulness and well-being, lowering stress levels and reducing fatigue. Some of these effects lasted more than three months after fasting.