Background and aims: Observational data indicate that diets rich in fruits and vegetables have a positive effect on inflammatory status, improve metabolic resilience and may protect against the development of non-communicable diseases. Nevertheless, experimental evidence demonstrating a causal relationship between nutrient intake (especially whole foods) and changes in metabolic health is scarce. This study investigated the pleiotropic effects of sulforaphane from broccoli sprouts, compared to pea sprouts, on biomarkers of endothelial function, inflammation and metabolic stress in healthy participants subjected to a standardized caloric challenge.Methods: In this double-blind, crossover, randomized, placebo-controlled trial 12 healthy participants were administered 16 g broccoli sprouts, or pea sprouts (placebo) followed by the standardized high-caloric drink PhenFlex given to disturb healthy homeostasis. Levels of inflammatory biomarkers and metabolic parameters were measured in plasma before and 2 h after the caloric overload.Results: Administration of broccoli sprouts promoted an increase in levels of CCL-2 induced by caloric load (p = 0.017). Other biomarkers (sICAM-1, sVCAM-1, hs-CRP, and IL-10) individually showed insignificant tendencies toward increase with administration of sulforaphane. Combining all studied biomarkers into the systemic low-grade inflammation score further confirmed upregulation of the inflammatory activity (p = 0.087) after sulforaphane. No significant effects on biomarkers of metabolic stress were detected.Conclusion: This study has demonstrated that sulforaphane facilitated development of a mild pro-inflammatory state during the caloric challenge, which could be suggestive of the onset of the hormetic response induced by this phytonutrient. The use of integrative outcomes measures such as the systemic low-grade inflammation score can be viewed as a more robust approach to study the subtle and pleiotropic effects of phytonutrients.Clinical trial registration:www.clinicaltrials.gov, identifier NCT05146804.Keywords: biomarkers; diet; glucoraphanin; hormesis; inflammation; nutrients; phenotypic flexibility; sulforaphane.
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From the website of the publisher: "Background Nocturnal sialorrhea is one of the most frequent adverse events in clozapine treatment. Symptomatic management of sialorrhea usually consists of off-label treatment with anticholinergic agents. The aim of the current study is to evaluate the efficacy and safety of glycopyrrolate in patients using clozapine that experience sialorrhea. Methods In a double-blind randomized crossover trial, patients with nocturnal sialorrhea (n = 32) were randomized to treatment with glycopyrrolate 1 mg or placebo. This double-blinded phase was followed by an optional open label extension phase with glycopyrrolate 2 mg. Exposure periods consisted of 6 consecutive days and were separated with 1 washout week. The primary outcome was clinical improvement of nocturnal sialorrhea assessed by the Patient Global Impression of Improvement (PGI-I). Results The proportion of patients with a clinical improvement according to PGI-I did not significantly differ between 1 mg and placebo (18.8% vs 6.3%, P = 0.289); however, in patients using glycopyrrolate 2 mg once daily versus placebo, it did (43.5% vs 6.3%, P = 0.039). Glycopyrrolate was not associated with severe adverse events or worsening of cognitive adverse events. Conclusions Glycopyrrolate 1 mg was not superior to placebo, whereas 2 mg showed a significant clinical improvement of nocturnal sialorrhea compared with placebo. Glycopyrrolate seemed to be a tolerable anticholinergic agent in the treatment of clozapine-associated sialorrhea"
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Abstract Background: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem.
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Background: Recent theoretical models emphasize the role of impulsive processes in alcohol addiction, which can be retrained with computerized Cognitive Bias Modification (CBM) training. In this study, the focus is on action tendencies that are activated relatively automatically. Objective: The aim of the study is to examine the effectiveness of online CBM Alcohol Avoidance Training using an adapted Approach-Avoidance Task as a supplement to treatment as usual (TAU) in an outpatient treatment setting. Methods: The effectiveness of 8 online sessions of CBM Alcohol Avoidance Training added to TAU is tested in a double-blind, randomized controlled trial with pre- and postassessments, plus follow-up assessments after 3 and 6 months. Participants are adult patients (age 18 years or over) currently following Web-based or face-to-face TAU to reduce or stop drinking. These patients are randomly assigned to a CBM Alcohol Avoidance or a placebo training. The primary outcome measure is a reduction in alcohol consumption. We hypothesize that TAU + CBM will result in up to a 13-percentage point incremental effect in the number of patients reaching the safe drinking guidelines compared to TAU + placebo CBM. Secondary outcome measures include an improvement in health status and a decrease in depression, anxiety, stress, and possible mediation by the change in approach bias. Finally, patients’ adherence, acceptability, and credibility will be examined. Results: The trial was funded in 2014 and is currently in the active participant recruitment phase (since May 2015). Enrolment will be completed in 2019. First results are expected to be submitted for publication in 2020. Conclusions: The main purpose of this study is to increase our knowledge about the added value of online Alcohol Avoidance Training as a supplement to TAU in an outpatient treatment setting. If the added effectiveness of the training is proven, the next step could be to incorporate the intervention into current treatment.
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Background: Weight loss is key to treatment of older adults with obesity and type 2 diabetes, but also a risk for muscle mass loss. This study investigated whether a whey protein drink enriched with leucine and vitamin D could preserve muscle mass and improve glycemic control during combined lifestyle intervention in this population. Methods: 123 older adults with obesity and type 2 diabetes were randomized into a 13-week lifestyle intervention with dietary advice and exercise, receiving either the enriched protein drink (test) or an isocaloric control (control). Muscle mass was assessed with dual-energy X-ray absorptiometry and glycemic control by oral glucose tolerance test. Statistical analyses were performed using a linear mixed model. Results: There was a nonsignificant increase in leg muscle mass (+0.28 kg; 95% CI, −0.01 to 0.56) and a significant increase in appendicular muscle mass (+0.36 kg; 95% CI, 0.005 to 0.71) and total lean mass (+0.92 kg; 95% CI, 0.19 to 1.65) in test vs. control. Insulin sensitivity (Matsuda index) also increased in test vs. control (+0.52; 95% CI, 0.07 to 0.97). Conclusions: Use of an enriched protein drink during combined lifestyle intervention shows beneficial effects on muscle mass and glycemic control in older adults with obesity and type 2 diabetes.
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Background: Currently, the Ponseti method is the gold standard for treatment of clubfeet. For long-term func- tional evaluation of this method, gait analysis can be performed. Previous studies have assessed gait differences between Ponseti treated clubfeet and healthy controls. Research question/purpose: The aims of this systematic review were to compare the gait kinetics of Ponseti treated clubfeet with healthy controls and to compare the gait kinetics between clubfoot patients treated with the Ponseti method or surgically. Methods: A systematic search was performed in Embase, Medline Ovid, Web of Science, Scopus, Cochrane, Cinahl ebsco, and Google scholar, for studies reporting on gait kinetics in children with clubfeet treated with the Ponseti method. Studies were excluded if they only used EMG or pedobarography. Data were extracted and a risk of bias was assessed. Meta-analyses and qualitative analyses were performed. Results: Nine studies were included, of which five were included in the meta-analyses. The meta-analyses showed that ankle plantarflexor moment (95% CI -0.25 to -0.19) and ankle power (95% CI -0.89 to -0.60, were significantly lower in the Ponseti treated clubfeet compared to the healthy controls. No significant difference was found in ankle dorsiflexor and plantarflexor moment, and ankle power between clubfeet treated with surgery compared to the Ponseti method. Significance: Differences in gait kinetics are present when comparing Ponseti treated clubfeet with healthy controls. However, there is no significant difference between surgically and Ponseti treated clubfeet. These results give more insight in the possibilities of improving the gait pattern of patients treated for clubfeet.
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BACKGROUND: Depression in later life is a common mental disorder with a prevalence rate of between 3% and 35% for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation (BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy accessible intervention for both patients and health care workers (such as nurses), there is no research on the effectiveness of the intervention in inpatient depressed elderly.The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD. METHODS/DESIGN: The study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60 years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d = 0.7, we intend to include 51 participants per condition (n = 102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life. DISCUSSION: To our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly population. This research has been approved by the medical research ethics committee for health-care settings in the Netherlands (No. NL26878.029.09) and is listed in the Dutch Trial Register (NTR No.1809).
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An extended professional identity theory is proposed to enhance interprofessional collaboration. The purpose of this study is to investigate whether comparative feedback on interprofessional interaction can decrease the degree of profession-based dominance and general dominance in mixed profession groups. This observational study comprised a randomized double-blind pretest-posttest control group design with 19 mixed profession groups (10 intervention and nine control groups, each with three dental and three dental hygiene students). All groups received reflective feedback during two consecutive two hour team development meetings. Intervention groups also received comparative feedback. Profession-based dominance concerned the sum of three observation items (conversational turntaking, dominance and contributing ideas) with a three-point scale: −1 = dental dominance, 0 = no dominance, +1 = dental hygiene dominance. Polychoric correlations confirmed positive associations with the latent trait and an unidimensional underlying structure. Observation items were internally consistent (α > .70). General dominance concerned the sum of absolute values of observation items with a minimum value of zero (no dominance) and the maximum value of three (strong dominance). A two-way factorial ANOVA was performed. The results revealed a significant interaction effect with regard to general dominance, F(1,17) = 6.630, p = 0.020 and large effect size (partial eta squared = 0.28). Comparative feedback on interprofessional interaction decreases general dominance in mixed profession groups.
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The Middle East and North Africa region has been absent form stocktaking exercises on social accountability initiatives (SAI), an umbrella term to designate citizen-led tools aimed at socio-political change. We argue that this sidelining is unwarranted, given the proliferation of participatory governance initiatives, civic associations and popular mobilisation in Arab societies after 2011. Whereas the struggle for improved accountability in the Arab world remains under-researched, analysis of authoritarian regime tactics has proliferated. The fact is, however, that many Arab societies have experimented with mechanisms to apply political pressure on corrupt elites while international donors have launched diverse SAIs, including community score cards and participatory and gender-responsive budgeting initiatives. In this chapter, we first identify this double gap: not only has the literature on SAIs overlooked the MENA region but scholarship on the Middle East has largely failed to recognise initiatives launched across the region over the past decade as SAIs. Then, we aim to address the blind spot of Arab SAI’s as pathways towards improved governance. Finally, we present an overview of extant literature and introduce a set of four research questions to better understand what social accountability means for people on the ground. These questions focus on the various meanings of social accountability (musā’ala vs muhāsaba), its modes of mobilisation, the responses from authorities to such initiatives and their overall outcomes.
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Emergency care (from ambulance to emergency room) is focused on somatic care: fixing the body. When a patient with mental dysregulation who experiences ‘disproportionate feelings like fear, anger, sadness or confusion, possibly with associated behaviours’ (Van de Glind et al. 2023) does not get appropriate attention, this can result in the disruption of treatment and even psychological trauma upon trauma. To improve the emergency care process, the authors of this paper - health researchers and design researchers engaged in a project based on the experience-based co-design (EBCD) approach (Donetto et al. 2015; Bate and Robert 2007). EBCD is a method used to design better experiences in healthcare settings, in cooperation with (former) patients and healthcare professionals. The process of EBCD involves partnerships between stakeholders and the discovery and sensemaking of experiences through specialized methods to gain an understanding of the interface between user and service, to design new experiences (Bate and Robert 2007, 31). There is, however, an interesting challenge in bringing patients and care professionals together. In emergency care, patients depend greatly on their healthcare providers. The patients in this study had existing mental vulnerabilities and may have been traumatized by previous visits. We needed to enable these stakeholders to be equal partners with ownership and power, one of the characteristics of co-design in EBCD (Donetto et al. 2015). In this paper, we describe how we adapted and applied the EBCD method, with a focus on creating equal partnerships. We also reflect on the extent of our success and the diBiculties we encountered in attaining this objective.
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