UNASSIGNED: Schizophrenia, schizoaffective disorder, and bipolar affective disorder are debilitating psychiatric conditions characterized by a chronic pattern of emotional, behavioral, and cognitive disturbances. Shared psychopathology includes the pre-eminence of altered affective states, disorders of thoughts, and behavioral control. Additionally, those conditions share epidemiological traits, including significant cardiovascular, metabolic, infectious, and respiratory co-morbidities, resulting in reduced life expectancy of up to 25 years. Nutritional ketosis has been successfully used to treat a range of neurological disorders and preclinical data have convincingly shown potential for its use in animal models of psychotic disorders. More recent data from open clinical trials have pointed toward a dramatic reduction in psychotic, affective, and metabolic symptoms in both schizophrenia and bipolar affective disorder.
UNASSIGNED: to investigate the effects of nutritional ketosis via a modified ketogenic diet (MKD) over 14 weeks in stable community patients with bipolar disorder, schizoaffective disorder, or schizophrenia.
UNASSIGNED: A randomized placebo-controlled clinical trial of 100 non-hospitalized adult participants with a diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia who are capable of consenting and willing to change their diets.
UNASSIGNED: Dietitian-led and medically supervised ketogenic diet compared to a diet following the Australian Guide to Healthy Eating for 14 weeks.
UNASSIGNED: The primary outcomes include psychiatric and cognitive measures, reported as symptom improvement and functional changes in the Positive and Negative Symptoms Scale (PANSS), Young Mania Rating Scale (YMS), Beck Depression Inventory (BDI), WHO Disability Schedule, Affect Lability Scale and the Cambridge Cognitive Battery. The secondary metabolic outcomes include changes in body weight, blood pressure, liver and kidney function tests, lipid profiles, and markers of insulin resistance. Ketone and glucose levels will be used to study the correlation between primary and secondary outcomes. Optional hair cortisol analysis will assess long-term stress and variations in fecal microbiome composition. Autonomic nervous system activity will be measured via wearable devices (OURA ring and EMBRACE wristband) in the form of skin conductance, oximetry, continuous pulse monitoring, respiratory rate, movement tracking, and sleep quality. Based on the encouraging results from established preclinical research, clinical data from other neurodevelopment disorders, and open trials in bipolar disorder and schizophrenia, we predict that the ketogenic metabolic therapy will be well tolerated and result in improved psychiatric and metabolic outcomes as well as global measures of social and community functioning. We additionally predict that a correlation may exist between the level of ketosis achieved and the metabolic, cognitive, and psychiatric outcomes in the intervention group.

Obesity in the United States and Western countries represents a major health challenge associated with an increased risk of metabolic diseases, including cardiovascular disease, hypertension, diabetes, and certain cancers. Our past work revealed a more pronounced obesity-cancer link in certain ethnic groups, motivating us to develop a tailored dietary intervention called the Healthy Diet and Lifestyle 2 (HDLS2). The study protocol is described herein for this randomized six-month trial examining the effects of intermittent energy restriction (5:2 Diet) plus the Mediterranean dietary pattern (IER + MED) on visceral adipose tissue (VAT), liver fat, and metabolic biomarkers, compared to a standard MED with daily energy restriction (DER + MED), in a diverse participant group. Using MRI and DXA scans for body composition analysis, as well as metabolic profiling, this research aims to contribute to nutritional guidelines and strategies for visceral obesity reduction. The potential benefits of IER + MED, particularly regarding VAT reduction and metabolic health improvement, could be pivotal in mitigating the obesity epidemic and its metabolic sequelae. The ongoing study will provide essential insights into the efficacy of these energy restriction approaches across varied racial/ethnic backgrounds, addressing an urgent need in nutrition and metabolic health research. Registered Trial, National Institutes of Health, ClinicalTrials.gov (NCT05132686).

The objective of this study was to assess the feasibility and effectiveness of a novel WeChat applet-based personalized dietary intervention aimed at promoting healthier dietary intakes. A two-arm parallel, randomized, controlled trial was conducted in a real-world scenario and involved a total of 153 participants (the intervention group, n = 76; the control group, n = 77), lasting for 4 months in Shanghai, China. The intervention group had access to visualized nutrition evaluations through the applet during workday lunch time, while the control group received no interventions. A total of 3413 lunch dietary intake records were captured through the applet. Linear mixed models were utilized to assess the intervention effects over time. At baseline, the participants\' lunchtime dietary intakes were characterized by insufficient consumption of plant foods (86.9% of the participants) and excessive intake of animal foods (79.7% of the participants). Following the commencement of the intervention, the intervention group showed a significant decrease in the animal/plant food ratio (β = -0.03/week, p = 0.024) and the consumption of livestock and poultry meat (β = -1.80 g/week, p = 0.035), as well as a borderline significant increase in the consumption of vegetables and fruits (β = 3.22 g/week, p = 0.055) and plant foods (β = 3.26 g/week, p = 0.057) over time at lunch compared to the control group. The applet-based personalized dietary intervention was feasible and effective in improving dietary intakes and, consequently, possibly may manage body weight issues in real-world scenarios.

UNASSIGNED: Post-stroke fatigue (PSF) is a frequent problem in stroke survivors and often hinders their rehabilitation. PSF is difficult to treat, and pharmacological therapy is often ineffective. Transcranial direct current stimulation (tDCS) can modulate motor, sensory, cognitive and behavioral responses, as it alters neuronal activity by delivering a small amount of current via the scalp to the cortex, resulting in prolonged alterations to brain function. tDCS has been studied for the treatment of fatigue associated with other neurological diseases, namely, multiple sclerosis, Parkinson\'s disease and post-polio syndrome.
UNASSIGNED: This proposed project will examine the effect of tDCS on PSF.
UNASSIGNED: We will recruit 156 participants aged 18 to 80 with chronic stroke and allocate them equally to two groups (i.e., n = 78 per group).
UNASSIGNED: This proposed project will be a double-blind randomized control trial. The participants will be randomly divided into two groups. The control group will receive sham tDCS, and the treatment group will receive active tDCS. The latter treatment will involve application of a constant 2-mA current via one 5 × 5-cm anodal electrode positioned on the scalp over the C3 or C4 positions (motor cortex) of the lesioned hemisphere and one cathodal electrode positioned at the ipsilateral shoulder in two 20-min sessions per day for 5 days. The period of follow-up will be 4 weeks.
UNASSIGNED: The primary outcome measure will be a change in fatigue severity, as measured using the modified fatigue impact scale (MFIS). The participants\' scores on the MFIS (total score and physical, cognitive and psychosocial subscores) will be collected before treatment (T0), after 10 treatment sessions, i.e., 1 day after the fifth treatment day (T1), and 1 week (T2), 2 weeks (T3) and 4 weeks (T4) thereafter. Both per-protocol analysis and intention-to-treat analysis will be performed.
UNASSIGNED: This proposed project will provide proof-of-concept, i.e., demonstrate the benefits of tDCS for the treatment of PSF. The beneficiaries are the subjects participated in the study. This will stimulate further research to optimize tDCS parameters for the treatment of PSF.
UNASSIGNED: www.Chictr.org.cn, identifier: ChiCTR2100052515.

UNASSIGNED: In several settings in the treatment of gastrointestinal cancers, it is unclear if the addition of surgery to a multimodal treatment strategy, or in some circumstances its omission, lead to a better outcome for patients. In such situations of clinical equipoise, high-quality evidence from randomised-controlled trials is needed to decide which treatment approach is preferable.
UNASSIGNED: In this article, we outline the importance of randomised trials comparing surgery with non-surgical therapies for specific scenarios in the treatment of gastrointestinal cancers. We explain the difficulties and solutions of designing these trials and recruiting patients in this context.
UNASSIGNED: We performed a selective review based on a not systematic literature search in core databases, supplemented by browsing health information journals and citation searching. Only articles in English were selected. Based on this search, we discuss the results and methodological characteristics of several trials which randomised patients with gastrointestinal cancers between surgery and non-surgical treatments, highlighting their differences, advantages, and limitations.
UNASSIGNED: Innovative and effective cancer treatment requires randomised trials, also comparing surgery and non-surgical treatments for defined scenarios in the treatment of gastrointestinal malignancies. Nevertheless, potential obstacles to designing and carrying out these trials must be recognised ahead of time to avoid problems before or during the trial.

UNASSIGNED: Over seven million women die from cardiovascular disease (CVD) annually. While lifestyle modification is recommended for CVD prevention, there are no systematic reviews evaluating the effectiveness of interventions targeted to women. The primary aim of this systematic review is to determine the efficacy of primary and secondary CVD prevention interventions targeting lifestyle risk factors in women.
UNASSIGNED: Six electronic databases were searched up to January 2022. Eligible studies included randomized controlled trials of primary or secondary CVD prevention interventions targeting CVD lifestyle risk factors (diet, physical activity, sedentary behavior, smoking, alcohol, sleep, and weight management) in women (≥18 years) that reported CVD risk markers or lifestyle risk factors. Meta-analyses were conducted on CVD risk markers and body mass index (BMI), and the level of evidence was applied to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria and reported.
UNASSIGNED: Thirty-five RCTs were included (24 primary and 11 secondary prevention). Meta-analyses demonstrated that lifestyle CVD prevention interventions achieved statistically significant reductions in BMI at ≤ 6 months (0.95 kg/m2, 95% CI = 0.54 to 1.35, p < 0.0001), 12 months (0.61 kg/m2, 95% CI = 0.07 to 1.16, p = 0.03) and >12 months (0.58 kg/m2, 95% CI = 0.01 to 1.16, p = 0.05), and systolic blood pressure (mmHg) at ≤ 6 months (3.51, p < 0.001).
UNASSIGNED: Lifestyle interventions are important for the prevention of CVD in women, specifically to reduce systolic blood pressure in the short term (≤ 6 months) and BMI long term (>12 months).
UNASSIGNED: https://osf.io/bkwqm, identifier: osf-registrations-bkwqm-v1.

UNASSIGNED: Pharmaceutical drugs are beneficial to inflammatory conditions but with side effects, which led to the search for alternative therapies. Perna canaliculus, the New Zealand green-lipped mussel, have shown promise in placebo-controlled trials for inflammatory conditions. Fucoidan, an extract from seaweed Undaria pinnatifida, has been found to have beneficial effects on joint pain and insulin resistance. However, green-lipped mussel and fucoidan have never been combined.
UNASSIGNED: A parallel, two-arm, double-blind, randomized, placebo-controlled trial will be conducted in New Zealand to determine whether a food product supplemented with green-lipped mussel and fucoidan improves joint pain and/or insulin resistance. Those who are ethnically Chinese, are aged over 30 years, have prediabetes and hip or knee joint pain will be eligible to participate. They will be randomized at 1:1 ratio to consume either dark chocolate supplemented with 1000 mg mussel powder and 1000 mg fucoidan or dark chocolate with no active substances daily for 100 days. The primary endpoints are change in insulin resistance and patient-reported joint pain. Secondary endpoints include anthropometry, fasting glucose and insulin, HbA1c, inflammatory markers, satiety, quality of life, physical function, pain intensity, and analgesic medication use. A sample size of 150 (75 per arm) will provide 90% power at an overall significance level of 5% (two-sided) to detect a standardized effect size of 0.625 on either of the two co-primary outcomes allowing for 10% loss.
UNASSIGNED: The study was approved by the Health and Disability Ethics Committee (number: 20/STH/153). Results will be made available to participants, funders, and other researchers.
UNASSIGNED: This trial will provide data on the potential utility of a mussel-fucoidan supplement in reducing joint pain and/or insulin resistance, to inform the development of a supplemented food product suitable for the Chinese market.
UNASSIGNED: https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12621000413820, ANZCTR Registration: ACTRN12621000413820, on 15 April 2021.

This paper investigates the effect of information about cross-country ratings of the government\'s and the public\'s reaction to the COVID-19 pandemic on consumers\' macroeconomic expectations and sentiment. We conduct consumer surveys with randomized control trials (RCTs) in two waves in Thailand and Vietnam. The information treatments have the strongest effect when the information shown contradicts consumers\' prior beliefs. In the first survey, conducted when the first lockdown was eased, treatment effects are stronger in Vietnam, causing more optimistic expectations and sentiment. In the second survey, conducted at the start of the second wave of infections, treatment effects are stronger in Thailand, causing a more pessimistic outlook.

UNASSIGNED: Refractory septic shock (RSS) is characterized by high vasopressor requirements, as a consequence of vasopressor resistance, which may be caused or enhanced by sympathetic hyperactivation. Experimental models and clinical trials show a reduction in vasopressor requirements and improved microcirculation compared to conventional sedation. Dexmedetomidine did not reduce mortality in clinical trials, but few septic shock patients were enrolled. This pilot trial aims to evaluate vasopressor re-sensitization with dexmedetomidine and assess the effect size, in order to design a larger trial.
UNASSIGNED: This is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial, comparing dexmedetomidine versus placebo in RSS patients with norepinephrine dose ≥0.5μg/kg/min. The primary outcome is blood pressure response to phenylephrine challenge, 6 hours after completion of a first challenge, after study treatment initiation. Secondary outcomes include feasibility and safety outcomes (bradycardia), mortality, vasopressor requirements, heart rate variability, plasma and urine catecholamines levels. The sample size is estimated at 32 patients to show a 20% improvement in blood pressure response to phenylephrine. Randomization (1:1) will be stratified by center, sedation type and presence of liver cirrhosis. Blood pressure and ECG will be continuously recorded for the first 24 h, enabling high-quality data collection for the primary and secondary endpoints. The study was approved by the ethics committee \"Sud-Est VI\" (2019-000726-22) and patients will be included after informed consent.
UNASSIGNED: The present study will be the first randomized trial to specifically address the hemodynamic effects of dexmedetomidine in patients with septic shock. We implement a high-quality process for data acquisition and recording in the first 24 h, ensuring maximal quality for the evaluation of both efficacy and safety outcomes, as well as transparency of results. The results of the study will be used to elaborate a full-scale randomized controlled trial with mortality as primary outcome in RSS patients.
UNASSIGNED: Registered with ClinicalTrials.gov (NCT03953677). Registered 16 May 2019, https://clinicaltrials.gov/ct2/show/NCT03953677.

UNASSIGNED: Loss of masticatory function consequent to tooth loss has been associated with changes in food choices and insufficient nutritional intake. To date, interventions based on dental prostheses alone did not significantly improve nutrient intake. Pilot studies have shown positive impacts of interventions combining implant-supported fixed dental prosthesis with brief dietary advice. The relative contribution and the potential synergy of the components of such interventions need to be determined as it has major public health implications for the community-dwelling aging population that continues to disproportionately suffer from tooth loss and its consequences.
UNASSIGNED: To assess the effect of rehabilitation of masticatory function with fixed implant supported dentures and nutrition education in older subjects with terminal dentition (stage IV periodontitis) or full edentulism.
UNASSIGNED: A 2 × 2 factorial randomized controlled trial with 16-month follow-up of eligible adults (≥60 years) with loss of masticatory function consequent to full arch edentulism or terminal dentition (n = 120) will be conducted to test whether the rehabilitation of masticatory function with fixed implant supported dentures, nutrition education and/or their combination improves intake of fresh fruits and vegetables for aging subjects. The study has been designed to detect changes in fresh fruits and fresh vegetables intake at 4 months using the 24-h dietary recall method. Changes in protein as percentage of total energy, nutritional biomarkers, plasma metabolomics, oral and gut microbiome, quality of life and masticatory function will also be assessed.
UNASSIGNED: We hypothesize that receiving rehabilitation of masticatory function with fixed implant dentures together with nutrition education is the most effective intervention for improving nutrient intake in aging community-dwelling subjects with extensive tooth loss. The results of this study will assist in designing better treatment regimens, guide medical care for individual subjects, and inform public health and policy.
UNASSIGNED: NCT05334407.