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Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019.
Liu, X, Wu, S, Sun, J, Ni, S, Lu, L, Hu, W, Wei, H, Zou, Y, Li, T, Li, J, et al
Pharmacology research & perspectives. 2021;(2):e00729
Abstract
With the improvements in relevant policies, laws, and regulations regarding drug clinical trials in China, the quantity and quality of drug clinical trials have gradually improved, and the development prospects of drug clinical trials for endocrine disorders and metabolism and nutrition disorders are promising. Based on information from the clinical trials from the online drug clinical trial registration platform of the National Medical Products Administration, we aimed to review and evaluate the development of clinical trials of drugs for endocrine disorders and metabolism and nutrition disorders in mainland China from 2010 to 2019, as well as the trends over time. A total of 861 trials were carried out on 254 types of drugs for endocrine disorders and metabolism and nutrition disorders, among which 531 (61.67%) involved endocrine disorders, and 330 (38.33%) addressed metabolism and nutrition disorders. The annual number of clinical trials has been increasing gradually, with a significant increase in 2017. Among them, the proportion of clinical trials with Chinese epidemiological characteristics was relatively large (Wu, Annual Report on Development Health Management and Health Industry in China, 2018). The largest number of trials were for diabetes drugs (55.63%), followed by trials of drugs for hyperlipidemia (19.4%) and those for hyperuricemia (7.9%). It was found that the geographical area of the leading units also showed obvious unevenness according to the analysis of the test unit data. Based on the statistics and evaluation of the data, comprehensive information is provided to support the cooperation of global pharmaceutical R&D companies and research units in China and the development of international multicenter clinical trials in China. This work additionally provides clinical trial units with a self-evaluation of scientific research competitiveness and hospital development strategies. At the same time, it provides a reference with basic data for sponsors and stakeholders in these trials to determine their development strategy goals.
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Nutritional implications of opioid use disorder: A guide for drug treatment providers.
Chavez, MN, Rigg, KK
Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors. 2020;(6):699-707
Abstract
The number of Americans seeking treatment for opioid use disorder (OUD) continues to increase. However, there are important nutritional implications of having OUD that often get overlooked by drug treatment providers. OUDs can cause metabolic changes, constipation, and weight loss, or lead to a lifestyle that results in inadequate food intake and unhealthy eating patterns. Nutritional factors associated with OUD can also hinder treatment outcomes and recovery. Addiction providers tend to give little attention to the nutritional implications of OUD, and this knowledge is rarely incorporated into treatment plans. The goal of this article, therefore, is to summarize the existing literature on the connection between OUD and nutrition to help guide treatment programs. This article (a) describes the nutritional consequences associated with misusing opioids, (b) discusses the role that nutrition can play in OUD treatment and recovery, (c) summarizes the nutritional implications of medication treatment for OUD, and (d) recommends nutritional interventions that might aid in the treatment of OUD. This article directly fills a gap in the OUD literature and has the potential to serve as a guide for drug treatment providers to make more informed nutritional recommendations to their clients. Treatment programs may wish to consider the issues raised in this paper before launching nutritional programs at their facility. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
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What is nutritional assessment? A quick guide for critical care clinicians.
Ferrie, S
Australian critical care : official journal of the Confederation of Australian Critical Care Nurses. 2020;(3):295-299
Abstract
Nutritional status is associated with patient outcomes such as length and cost of hospital stay, morbidity, and mortality. Trained nutrition professionals perform nutritional assessment to evaluate the patient's nutritional status, identify nutritional risk, and plan appropriate nutrition interventions. By being aware of key nutrition risk factors and by using simple methods to assess muscle stores, which may be depleted even if the patient is overweight or obese, other members of the healthcare team can help to identify who is at nutritional risk and who may be malnourished. This is helpful in identifying which patients should be referred promptly to a dietitian for appropriate nutrition therapy to improve outcomes.
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Helping With Meal Preparation and Children's Dietary Intake: A Literature Review.
Quelly, SB
The Journal of school nursing : the official publication of the National Association of School Nurses. 2019;(1):51-60
Abstract
Most children and adolescents do not meet dietary recommendations that may result in poor diets contributing to obesity. This systematic literature review was conducted to examine associations between helping with meal preparation at home and dietary quality, intake of specific foods, and/or dietary-related perceptions among youth. A search of databases using key terms was conducted for studies meeting criteria. This literature review included 15 studies using a cross-sectional descriptive design, with two studies also including a longitudinal design. Data were self-reported (or parent-reported) using various surveys and/or interviews. Study findings supported positive associations between youth involvement in home meal preparation and improvement in overall dietary quality, increased consumption of fruits and vegetables, greater preference for vegetables, and higher self-efficacy for cooking and choosing healthy foods. Further research is needed to develop efficacious meal preparation interventions involving parents and their children to promote this mealtime behavior with many potential health benefits.
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5.
Nutritional Issues and Positive Living in Human Immunodeficiency Virus/AIDS.
Clark, WA, Cress, EM
The Nursing clinics of North America. 2018;(1):13-24
Abstract
Nutritional counseling has been shown to improve dietary intake in individuals with human immunodeficiency virus (HIV)/AIDS. Registered dietitians/nutritionists can individualize diet interventions to optimize effectiveness in treating metabolic consequences of the HIV infection or highly active antiretroviral therapy. Nutrition management for individuals infected with HIV can be helpful in maintaining lean body weight, combating oxidative stress, reducing complications from hyperglycemia and hyperlipidemia, and managing gastrointestinal function. Consideration should be given to including the expertise of a registered dietitian/nutritionist.
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6.
Can adverse effects of excessive vitamin D supplementation occur without developing hypervitaminosis D?
Razzaque, MS
The Journal of steroid biochemistry and molecular biology. 2018;:81-86
Abstract
Vitamin D is a fat-soluble hormone that has endocrine, paracrine and autocrine functions. Consumption of vitamin D-supplemented food & drugs have increased significantly in the last couple of decades due to campaign and awareness programs. Despite such wide use of artificial vitamin D supplements, serum level of 25 hydroxyvitamin D does not always reflect the amount of uptake. In contrast to the safe sunlight exposure, prolonged and disproportionate consumption of vitamin D supplements may lead to vitamin D intoxication, even without developing hypervitaminosis D. One of the reasons why vitamin D supplementation is believed to be safe is, it rarely raises serum vitamin D levels to the toxic range even after repeated intravenous ingestion of extremely high doses of synthetic vitamin D analogs. However, prolonged consumption of vitamin D supplementation may induce hypercalcemia, hypercalciuria and hyperphosphatemia, which are considered to be the initial signs of vitamin D intoxication. It is likely that calcium and phosphorus dysregulation, induced by exogenous vitamin D supplementation, may lead to tissue and organ damages, even without developing hypervitaminosis D. It is needed to be emphasized that, because of tight homeostatic control of calcium and phosphorus, when hypercalcemia and/or hyperphosphatemia is apparent following vitamin D supplementation, the process of tissue and/or organ damage might already have been started.
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Metabolic and Nutritional Consequences of Urinary Diversion Using Intestinal Segments to Reconstruct the Urinary Tract.
Roth, JD, Koch, MO
The Urologic clinics of North America. 2018;(1):19-24
Abstract
Intestinal segments in various forms have been used to reconstruct the urinary tract since the mid-1800s. Currently, many different forms of continent and incontinent diversion options exist. Incorporating bowel mucosa within the urinary tract leads to predictable metabolic and nutritional consequences. The use of ileum or colon can cause a hyperchloremic metabolic acidosis, vitamin B12 deficiency, osteoporosis, fat malabsorption, urinary calculi, and ammoniagenic encephalopathy. Due to metabolic and nutritional consequences associated with the use of jejunum and gastric segments, the use of these bowel segments is not recommended.
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Environmental and behavioural modifications for improving food and fluid intake in people with dementia.
Herke, M, Fink, A, Langer, G, Wustmann, T, Watzke, S, Hanff, AM, Burckhardt, M
The Cochrane database of systematic reviews. 2018;(7):CD011542
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Abstract
BACKGROUND Weight loss, malnutrition and dehydration are common problems for people with dementia. Environmental modifications such as, change of routine, context or ambience at mealtimes, or behavioural modifications, such as education or training of people with dementia or caregivers, may be considered to try to improve food and fluid intake and nutritional status of people with dementia. OBJECTIVES Primary: To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia. Secondary: To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia. To assess the adverse consequences or effects of the included interventions. SEARCH METHODS We searched the Specialized Register of Cochrane Dementia and Cognitive Improvement (ALOIS), MEDLINE, Eembase, PsycINFO, CINAHL, ClinicalTrials.gov and the World Health Organization (WHO) portal/ICTRP on 17 January 2018. We scanned reference lists of other reviews and of included articles. SELECTION CRITERIA We included randomised controlled trials (RCTs) investigating interventions designed to modify the mealtime environment of people with dementia, to modify the mealtime behaviour of people with dementia or their caregivers, or both, with the intention of improving food and fluid intake. We included people with any common dementia subtype. DATA COLLECTION AND ANALYSIS Two review authors independently selected studies, extracted data and assessed the risk of bias of included trials. We assessed the quality of evidence for each outcome using the GRADE approach. MAIN RESULTS We included nine studies, investigating 1502 people. Three studies explicitly investigated participants with Alzheimer's disease; six did not specify the type of dementia. Five studies provided clear measures to identify the severity of dementia at baseline, and overall very mild to severe stages were covered. The interventions and outcome measures were diverse. The overall quality of evidence was mainly low to very low.One study implemented environmental as well as behavioural modifications by providing additional food items between meals and personal encouragement to consume them. The control group received no intervention. Differences between groups were very small and the quality of the evidence from this study was very low, so we are very uncertain of any effect of this intervention.The remaining eight studies implemented behavioural modifications.Three studies provided nutritional education and nutrition promotion programmes. Control groups did not receive these programmes. After 12 months, the intervention group showed slightly higher protein intake per day (mean difference (MD) 0.11 g/kg, 95% confidence interval (CI) -0.01 to 0.23; n = 78, 1 study; low-quality evidence), but there was no clear evidence of a difference in nutritional status assessed with body mass index (BMI) (MD -0.26 kg/m² favouring control, 95% CI -0.70 to 0.19; n = 734, 2 studies; moderate-quality evidence), body weight (MD -1.60 kg favouring control, 95% CI -3.47 to 0.27; n = 656, 1 study; moderate-quality evidence), or score on Mini Nutritional Assessment (MNA) (MD -0.10 favouring control, 95% CI -0.67 to 0.47; n = 656, 1 study; low-quality evidence). After six months, the intervention group in one study had slightly lower BMI (MD -1.79 kg/m² favouring control, 95% CI -1.28 to -2.30; n = 52, 1 study; moderate-quality evidence) and body weight (MD -8.11 kg favouring control, 95% CI -2.06 to -12.56; n = 52, 1 study; moderate-quality evidence). This type of intervention may have a small positive effect on food intake, but little or no effect, or a negative effect, on nutritional status.Two studies compared self-feeding skills training programmes. In one study, the control group received no training and in the other study the control group received a different self-feeding skills training programme. For both comparisons the quality of the evidence was very low and we are very uncertain whether these interventions have any effect.One study investigated general training of nurses to impart knowledge on how to feed people with dementia and improve attitudes towards people with dementia. Again, the quality of the evidence was very low so that we cannot be certain of any effect.Two studies investigated vocal or tactile positive feedback provided by caregivers while feeding participants. After three weeks, the intervention group showed an increase in calories consumed per meal (MD 200 kcal, 95% CI 119.81 to 280.19; n = 42, 1 study; low-quality evidence) and protein consumed per meal (MD 15g, 95% CI 7.74 to 22.26; n = 42, 1 study; low-quality evidence). This intervention may increase the intake of food and liquids slightly; nutritional status was not assessed. AUTHORS' CONCLUSIONS Due to the quantity and quality of the evidence currently available, we cannot identify any specific environmental or behavioural modifications for improving food and fluid intake in people with dementia.
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Non-communicable diseases, food and nutrition in Vietnam from 1975 to 2015: the burden and national response.
Nguyen, TT, Hoang, MV
Asia Pacific journal of clinical nutrition. 2018;(1):19-28
Abstract
BACKGROUND AND OBJECTIVES This review manuscript examines the burden and national response to non-communicable diseases (NCDs), food and nutrition security in Vietnam from 1975 to 2015. METHODS AND STUDY DESIGN We extracted data from peer-reviewed manuscripts and reports of nationally representative surveys and related policies in Vietnam. RESULTS In 2010, NCDs accounted for 318,000 deaths (72% of total deaths), 6.7 million years of life lost, and 14 million disability-adjusted life years in Vietnam. Cardiovascular diseases, cancers, chronic obstructive pulmonary disease, and diabetes mellitus were major contributors to the NCD burden. Adults had an increased prevalence of overweight and obesity (2.3% in 1993 to 15% in 2015) and hypertension (15% in 2002 to 20% in 2015). Among 25-64 years old in 2015, the prevalence of diabetes mellitus was 4.1% and the elevated blood cholesterol was 32%. Vietnamese had a low physical activity level, a high consumption of salt, instant noodles and sweetened non-alcoholic beverages as well as low consumption of fruit and vegetables and seafood. The alcohol consumption and smoking prevalence were high in men. Exposure to second-hand tobacco smoke was high in men, women and youths at home, work, and public places. In Vietnam, policies for NCD prevention and control need to be combined with strengthened law enforcement and increased program coverage. There were increased food production and improved dietary intake (e.g., energy intake and protein-rich foods thanked to appropriate economic, agriculture, and nutrition strategies. CONCLUSIONS NCDs and their risk factors are emerging problems in Vietnam, which need both disease-specific and sensitive strategies in health and related sectors.
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Metabolic and nutritional complications of bariatric surgery : a review.
Mesureur, L, Arvanitakis, M
Acta gastro-enterologica Belgica. 2017;(4):515-525
Abstract
Bariatric surgery is considered as the only effective durable weight-loss therapy and may be curative for obesity-related comorbidities such as diabetes. Nevertheless this surgery is not devoid of potential long-term complications such as dumping syndrome, gastroesophageal reflux disease and nutrient deficiencies. For this reason, preoperative nutritional assessment and rigorous postoperative follow-up with administration of multi-vitamins supplements and assessment of serum levels is recommended for each patient who is undergoing a bariatric surgery. The aim of this review is to identify and treat the metabolic and nutritional complications of bariatric surgery.