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Enriched trial design

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https://www.readbyqxmd.com/read/28318688/impact-of-phenylketonuria-type-meal-on-appetite-thermic-effect-of-feeding-and-postprandial-fat-oxidation
#1
Hani Alfheeaid, Konstantinos Gerasimidis, Ana-Maria Năstase, Mie Elhauge, Barbara Cochrane, Dalia Malkova
BACKGROUND: Dietary management of phenylketonuria (PKU) requires the replacement of natural protein-containing foods with special low protein foods. The effect of a PKU type diet on factors contributing to energy balance requires investigation. OBJECTIVE: To investigate the impact of a PKU type meal on appetite ratings, gut appetite hormones, thermic effect of feeding (TEF) and fat oxidation. METHODS: Twenty-three healthy adults (mean ± SD age: 24...
March 8, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28228425/prebiotic-supplementation-improves-appetite-control-in-children-with-overweight-and-obesity-a-randomized-controlled-trial
#2
Megan P Hume, Alissa C Nicolucci, Raylene A Reimer
Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk...
February 22, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28222742/resistant-starch-lowers-postprandial-glucose-and-leptin-in-overweight-adults-consuming-a-moderate-to-high-fat-diet-a-randomized-controlled-trial
#3
Mindy Patterson Maziarz, Sara Preisendanz, Shanil Juma, Victorine Imrhan, Chandan Prasad, Parakat Vijayagopal
BACKGROUND: High-amylose maize resistant starch type 2 (HAM-RS2) stimulates gut-derived satiety peptides and reduces adiposity in animals. Human studies have not supported these findings despite improvements in glucose homeostasis and insulin sensitivity after HAM-RS2 intake which can lower adiposity-related disease risk. The primary objective of this study was to evaluate the impact of HAM-RS2 consumption on blood glucose homeostasis in overweight, healthy adults. We also examined changes in biomarkers of satiety (glucagon-like peptide-1 [GLP-1], peptide YY [PYY], and leptin) and body composition determined by anthropometrics and dual-energy x-ray absorptiometry, dietary intake, and subjective satiety measured by a visual analogue scale following HAM-RS2 consumption...
February 21, 2017: Nutrition Journal
https://www.readbyqxmd.com/read/28222360/maintenance-therapy-with-second-generation-antipsychotics-for-bipolar-disorder-a-systematic-review-and-meta-analysis
#4
REVIEW
Leif Lindström, Eva Lindström, Mikael Nilsson, Malin Höistad
BACKGROUND: Second generations antipsychotics (SGA) are frequently used for maintenance treatment in bipolar disorder. We systematically reviewed the efficacy and long-term effects of treatment with SGA, regardless of treatment strategy (SGA administered either as monotherapy or as adjunctive therapy), in comparison to placebo, lithium or valproate. Primary outcomes were relapses (mood episode recurrence) and discontinuation. METHOD: Clinical studies were identified through database searching in PubMed, Embase, PsychInfo and Cochrane Library and critically appraised based on the Cochrane Handbook...
February 14, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28217765/personalized-medicine-enrichment-design-for-dha-supplementation-clinical-trial
#5
Yang Lei, Matthew S Mayo, Susan E Carlson, Byron J Gajewski
Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28157671/can-wheat-germ-have-a-beneficial-effect-on-human-health-a-study-protocol-for-a-randomised-crossover-controlled-trial-to-evaluate-its-health-effects
#6
André Moreira-Rosário, Helder Pinheiro, Conceição Calhau, Luís Filipe Azevedo
INTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now...
November 10, 2016: BMJ Open
https://www.readbyqxmd.com/read/28141763/use-of-video-games-for-the-treatment-of-amblyopia
#7
Alexander J E Foss
PURPOSE OF REVIEW: To review the literature up to recent for the use of videos, videogames and dichoptic stimulation as a treatment for amblyopia. RECENT FINDINGS: There have been three strategies explored. The first is to use videos and videogames monocularly with the normal eye covered. The second is dichoptic stimulation with a common background presented to both eyes and an enriched foreground to the amblyopic eye. The third are games specifically designed to generate stereopsis...
January 30, 2017: Current Opinion in Ophthalmology
https://www.readbyqxmd.com/read/28103052/adjunctive-treatment-of-psychotic-disorders-with-micronutrients
#8
Lewis Mehl-Madrona, Barbara Mainguy
OBJECTIVE: To evaluate the effect of micronutrients (minerals and vitamins) on adult psychosis when added to conventional medications by using a placebo-controlled randomized design with a 1-month open-label run-in. DESIGN: Longitudinal comparison study following a randomized, controlled trial that had failed because participants declined to undergo randomization. Setting/Locations: Rural primary care and psychiatry clinic in northern New England (town of 16,000 people)...
January 19, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/28072811/evaluation-of-the-ototoxicity-potential-of-once-daily-single-entity-hydrocodone-in-patients-with-chronic-pain-results-of-two-phase-3-clinical-studies
#9
Kathleen Campbell, J Walter Kutz, Angela Shoup, Warren Wen, Shau Yu Lynch, Ellie He, Steven R Ripa
BACKGROUND: Use/misuse of the opioid combination hydrocodone-acetaminophen has been associated with permanent hearing loss. Although reports have been rare, this potential effect can have significant detrimental effect on patients' overall quality of life. To date, the ototoxic effect of hydrocodone alone has not been systematically investigated. OBJECTIVE: In this report, we aimed to evaluate the potential ototoxicity of a novel, single-entity, once-daily, extended-release hydrocodone tablet (Hysingla® ER; HYD)...
January 2017: Pain Physician
https://www.readbyqxmd.com/read/28068927/subgroup-identification-of-early-preterm-birth-eptb-informing-a-future-prospective-enrichment-clinical-trial-design
#10
Chuanwu Zhang, Lili Garrard, John Keighley, Susan Carlson, Byron Gajewski
BACKGROUND: Despite the widely recognized association between the severity of early preterm birth (ePTB) and its related severe diseases, little is known about the potential risk factors of ePTB and the sub-population with high risk of ePTB. Moreover, motivated by a future confirmatory clinical trial to identify whether supplementing pregnant women with docosahexaenoic acid (DHA) has a different effect on the risk subgroup population or not in terms of ePTB prevalence, this study aims to identify potential risk subgroups and risk factors for ePTB, defined as babies born less than 34 weeks of gestation...
January 10, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28063238/aspergillus-awamori-fermented-mung-bean-seed-coats-enhance-the-antioxidant-and-immune-responses-of-weaned-pigs
#11
D N Lee, Y S Hung, T S Yang, J H Lin, C F Weng
The potential benefits of Aspergillus-fermented mung bean seed coats (FMSC) for weaned pigs remain unexplored. Both in vitro and in vivo experiments were employed to evaluate the potential of FMSC supplement on the growth, antioxidant and immune responses of weaned pigs. The total polyphenols and DPPH scavenging capability of ethanol extract of FMSC exhibited a greater (p < 0.01) increase than those of pre-fermentation. With the addition of the polyphenol of FMSC extract, an increase in phagocytosis by neutrophils and proliferation of peripheral blood mononuclear cells (PBMC) were found...
January 7, 2017: Journal of Animal Physiology and Animal Nutrition
https://www.readbyqxmd.com/read/28060849/behavior-of-pigs-reared-in-enriched-environment-alternatives-to-extend-pigs-attention
#12
Simone Pereira Machado, Fabiana Ribeiro Caldara, Luciana Foppa, Rafael de Moura, Liliane Maria Piano Gonçalves, Rodrigo Garófallo Garcia, Irenilza de Alencar Nääs, Viviane Maria Oliveira Dos Santos Nieto, Geyssane Farias de Oliveira
Three trials were carried out in a completely randomized design aiming to assess the behavior of pigs in growth phase in enriched environments. Trial 1 evaluated the effects of frequency of availability of environmental enrichment. The animals were assigned to four treatments: 1) control with no enrichment object; 2) objects provided for six consecutive days uninterruptedly; 3) objects provided on alternate days, and 4) objects provided for six consecutive days taken away by the end of the afternoon and replaced at dawn...
2017: PloS One
https://www.readbyqxmd.com/read/28000601/isolation-of-tasmanian-rickettsia-like-organism-rlo-from-farmed-salmonids-identification-of-multiple-serotypes-and-confirmation-of-pathogenicity
#13
R N Morrison, N D Young, G Knowles, M C Cornish, J Carson
Atlantic salmon Salmo salar L. farmed in south-east Tasmania, Australia, are susceptible to infection by the Tasmanian Rickettsia-like organism (TRLO), a Gram-negative bacterium. Here, we report the first isolation of TRLO from south-east Tasmania in pure culture and show that the bacterium is culturable on both specialised enriched agar and in cell culture using the CHSE-214 cell line. In vitro cultured TRLO was used to reproducibly elicit disease in Atlantic salmon parr held in fresh water. In inoculated fish, TRLO was observed intracytoplasmically in peripheral blood leucocytes, suggesting that these cells are responsible for haematogenous dispersal of the bacterium within the host...
December 21, 2016: Diseases of Aquatic Organisms
https://www.readbyqxmd.com/read/27980494/in-vivo-osteoinduction-evaluating-2-beta-coxatene-as-an-immunoinductive-compound-and-novel-ingredient-for-joint-support
#14
Katherine Spinks, James J Scaffidi
CONTEXT: Osteoarthritis (OA) is a degenerative joint disease characterized by progressive loss of articular cartilage. Many treatments lack the ability to stimulate the growth of native cartilage tissue while they simultaneously increase joint comfort. For the past few decades, dietary supplements have been investigated for the ability to both address joint inflammation and stimulate cartilage tissue. OBJECTIVES: The present study intended to examine the supplement's in vivo osteoinductive capabilities and clinical efficacy for overall joint health...
October 2016: Integrative Medicine
https://www.readbyqxmd.com/read/27919389/older-patients-use-of-technology-for-a-post-discharge-nutritional-intervention-a-mixed-methods-feasibility-study
#15
T Lindhardt, M H Nielsen
BACKGROUND: Malnutrition is frequent in older people and a precursor for morbidity and hospitalisation; furthermore low intake and weight loss during and after hospitalisation is well-described. Such patients are often excluded from technology projects on account of lack of skills. This is a barrier for their access to many current and future health care offers. OBJECTIVES: To test the acceptability, feasibility and preliminary efficacy of technology-supported energy- and protein-enforced homedelivered meals for older patients discharged from hospital...
January 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/27919361/adverse-effects-on-insulin-secretion-of-replacing-saturated-fat-with-refined-carbohydrate-but-not-with-monounsaturated-fat-a-randomized-controlled-trial-in-centrally-obese-subjects
#16
Lin F Chang, Shireene R Vethakkan, Kalanithi Nesaretnam, Thomas A B Sanders, Kim-Tiu Teng
BACKGROUND: Current dietary guidelines recommend the replacement of saturated fatty acids (SAFAs) with carbohydrates or monounsaturated fatty acids (MUFAs) based on evidence on lipid profile alone, the chronic effects of the mentioned replacements on insulin secretion and insulin sensitivity are however unclear. OBJECTIVE: To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects...
November 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27917685/phosphodiesterase-10-inhibitors-in-clinical-development-for-cns-disorders
#17
Hugo Geerts, Athan Spiros, Patrick Roberts
Phosphodiesterase 10 inhibitors (PDE10-I), are conceptually attractive drugs with a potential great therapeutic window as their enriched striatal localization may likely stimulate D1R and reduce D2R downstream effects. However, so far selective PDE10-I with efficacy in animal models have not shown benefit in clinical trials and unexpectedly revealed a substantial dyskinesia motor side-effect. Areas covered: This paper reviews the underlying biological rationale of PDE10 as a target in schizophrenia, Parkinson's and Huntington's disease based on peer-reviewed published articles, the status of the different PDE10-I in clinical development for various CNS indications and explores possible reasons for the clinical trial failures and translational disconnect...
December 10, 2016: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/27914517/effect-of-flaxseed-oil-and-microalgae-dha-on-the-production-performance-fatty-acids-and-total-lipids-of-egg-yolk-and-plasma-in-laying-hens
#18
M Neijat, O Ojekudo, J D House
The incorporation of omega-3 polyunsaturated fatty acids (PUFA) in the egg is dependent on both the transfer efficiency of preformed dietary omega-3 fatty acids to the eggs as well as endogenous PUFA metabolism and deposition. Employing an experimental design consisting of 70 Lohmann LSL-Classic hens (n=10/treatment) in a 6-week feeding trial, we examined the impact of graded levels of either flaxseed oil (alpha-linolenic acid, ALA) or algal DHA (preformed docosahexaenoic acid, DHA), each supplying 0.20%, 0...
December 2016: Prostaglandins, Leukotrienes, and Essential Fatty Acids
https://www.readbyqxmd.com/read/27899529/short-term-effects-of-trans-fatty-acids-from-ruminant-and-industrial-sources-on-surrogate-markers-of-cardiovascular-risk-in-healthy-men-and-women-a-randomized-controlled-double-blind-trial
#19
Thomas Radtke, Alexandra Schmid, Anja Trepp, Frieda Dähler, Michael Coslovsky, Prisca Eser, Matthias Wilhelm, Hugo Saner
Objective The aim of this study was to determine short-term effects of trans fatty acid (TFA) intake from ruminant and industrial sources on surrogate markers of cardiovascular risk in the context of a balanced diet with 30-36% of daily energy from fat. Design Prospective, randomized, double-blind, parallel-design study. Methods In this study, 142 healthy volunteers aged 45 to 69 years were randomly allocated to three different diets: either a diet enriched with 2% of daily energy intake from ruminant TFA (rTFA) or with industrial TFA (iTFA), or a diet without TFA (wTFA), for a duration of four weeks...
January 1, 2016: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/27895297/power-of-an-adaptive-trial-design-for-endovascular-stroke-studies-simulations-using-ims-interventional-management-of-stroke-iii-data
#20
Maarten G Lansberg, Ninad S Bhat, Sharon D Yeatts, Yuko Y Palesch, Joseph P Broderick, Gregory W Albers, Tze L Lai, Philip W Lavori
BACKGROUND AND PURPOSE: Adaptive trial designs that allow enrichment of the study population through subgroup selection can increase the chance of a positive trial when there is a differential treatment effect among patient subgroups. The goal of this study is to illustrate the potential benefit of adaptive subgroup selection in endovascular stroke studies. METHODS: We simulated the performance of a trial design with adaptive subgroup selection and compared it with that of a traditional design...
December 2016: Stroke; a Journal of Cerebral Circulation
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