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Randomized Controlled Trial Supplement

Nazarii Kobyliak, Ludovico Abenavoli, Tetyana Falalyeyeva, Galyna Mykhalchyshyn, Luigi Boccuto, Liudmyla Kononenko, Dmytro Kyriienko, Iuliia Komisarenko, Oleg Dynnyk
BACKGROUND: The manipulation of gut microbiota via administration of probiotics has been proposed as a potential strategy for the treatment of non-alcoholic fatty liver disease (NAFLD). Hence, we performed a double-blind single center randomized placebo-controlled trial (RCT) to evaluate the efficacy of co-administration of probiotics with omega-3 vs. placebo in type-2 diabetic patients with NAFLD. METHODS: A total of 48 patients met the criteria for inclusion. They were randomly assigned to receive "Symbiter Omega" combination of probiotic biomass supplemented with flax and wheat germ oil (250 mg of each, concentration of omega-3 fatty acids 1-5%) or placebo for 8-weeks...
September 13, 2018: Minerva Medica
Joseph Cyrus Parambeth, Geoffrey T Fosgate, Jan S Suchodolski, Jonathan A Lidbury, Jörg M Steiner
BACKGROUND: Pancreatic enzyme supplements for the treatment of exocrine pancreatic insufficiency (EPI) in dogs can be uncoated or enteric coated. Enteric coated supplements might be advantageous. HYPOTHESIS/OBJECTIVES: Enteric coated enzyme supplements are superior to uncoated supplements in dogs with clinical EPI. ANIMALS: Eleven dogs with naturally occurring EPI that were apparently free from other diseases. METHODS: Randomized, blinded, controlled cross-over clinical trial comparing a novel micro-encapsulated enteric coated enzyme supplement to a commercially available uncoated product in dogs with clinical EPI...
September 17, 2018: Journal of Veterinary Internal Medicine
He-Xiang Zong, Sheng-Qian Xu, Hui Tong, Xin-Rong Wang, Mei-Juan Pan, Yu-Zhu Teng
BACKGROUND: Efficacy of anti-tumor necrosis factor (anti-TNF)α treatment in patient with active ankylosing spondylitis (AS) had been proved by many clinical studies. Inflammation and new bone formation in spine were two pivotal aspects in AS. TNF α inhibitor could eliminate inflammation including clinical and laboratory inflammatory manifestation. Paradoxical results whether TNF α antagonist could delay radiographic progression in AS were often been reported simultaneously. OBJECTIVES: To review literature about effect of TNF α inhibitor on radiographic progression and disease activity in patient with AS...
September 15, 2018: Modern Rheumatology
Sarah King, Daniel Tancredi, Irene Lenoir-Wijnkoop, Kelsie Gould, Hailey Vann, Grant Connors, Mary Ellen Sanders, Jeffrey A Linder, Andi L Shane, Dan Merenstein
Background: Overall reduction of antibiotic use is a widely adopted public health goal. Given evidence that consuming probiotics reduce the incidence, duration and/or severity of certain types of common acute infections, we hypothesized that probiotics are associated with reduced antibiotic use. This systematic review of randomized controlled trials (RCTs) assessed the impact of probiotic supplementation (any strain, dose or duration), compared to placebo, on antibiotic utilization for common, acute infections in otherwise healthy people of all ages...
September 14, 2018: European Journal of Public Health
Waranya Watcharanon, Srinaree Kaewrudee, Sukree Soontrapa, Woraluk Somboonporn, Prasopsuk Srisaenpang, Ladawan Panpanit, Chatlert Pongchaiyakul
BACKGROUND: Despite the abundant sunlight in Thailand, vitamin D deficiency is common in premenopausal and postmenopausal Thai women. Sunlight exposure is a natural way to increase one's intake of vitamin D. However, limited research has been conducted regarding natural exposure to sunlight as a strategy to improve vitamin D status in postmenopausal women. OBJECTIVE: This study aimed to determine the effects of sunlight exposure compared with oral supplementation with vitamin D2 (weekly 20,000 IU) in combination with sunlight exposure on 25(OH)D levels...
October 2018: Complementary Therapies in Medicine
Reyhaneh Yousefi, Azadeh Mottaghi, Atoosa Saidpour
AIMS: Novel alternative treatments such as food supplements may be an effective approach to weight management. The aim of the present study was to investigate the possible effects of Spirulina Platensis (SP) on anthropometric measures, appetite and metabolic parameters in obese or overweight individuals. MATERIAL AND METHODS: A total of fifty-two obese and overweight subjects (25 kg/m2  ≤ body mass index (BMI) <40 kg/m2 ) were randomly selected to be allocated to SP (4 × 500 mg daily tablets along with restricted calorie diet (RCD)) or placebo (placebo tablets along with RCD) for 12 weeks of intervention...
October 2018: Complementary Therapies in Medicine
Soltanian Noureddin, Janghorbani Mohsen, Adibi Payman
OBJECTIVE: To compare the effects of baked psyllium supplementation versus those who received a placebo on constipation symptoms, body weight, glycemic and lipids control in patients with type 2 diabetes (T2D) and chronic constipation. METHODS: In a single-blinded, randomized controlled trial, 51 patients with T2D and chronic constipation with body mass index (BMI) 20-47 kg/m2 received either 10 g of psyllium pre-mixed in cookies twice per day or placebo cookies for 12 weeks...
October 2018: Complementary Therapies in Medicine
Navid Mazruei Arani, Zahra Emam-Djomeh, Hamid Tavakolipour, Reza Sharafati-Chaleshtori, Alireza Soleimani, Zatollah Asemi
To the best of our knowledge, this study is the first evaluating the effects of probiotic honey intake on glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress in patients with diabetic nephropathy (DN). This investigation was conducted to evaluate the effects of probiotic honey intake on metabolic status in patients with DN. This randomized, double-blind, controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 25 g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11 (IBRC-M10791) (108  CFU/g) or 25 g/day control honey (n = 30 each group) for 12 weeks...
September 14, 2018: Probiotics and Antimicrobial Proteins
Julia J Rucklidge, Matthew J F Eggleston, Kathryn Darling, Aaron Stevens, Martin Kennedy, Christopher M Frampton
BACKGROUND: Intent-to-treat analyses from a randomized controlled trial showed significant between-group differences favouring micronutrient treatment on the Clinical Global Impression-Improvement, but no group differences on clinician, parent and teacher ratings of overall ADHD symptoms. There was an advantage of micronutrients over placebo in improving overall function, emotional regulation, aggression, and reducing impairment as well as improving inattention based on clinician but not parent observation...
September 11, 2018: Progress in Neuro-psychopharmacology & Biological Psychiatry
Mehri Jamilian, Shirin Mansury, Fereshteh Bahmani, Zahra Heidar, Elaheh Amirani, Zatollah Asemi
BACKGROUND: The aim of this study was to evaluate the effect of the co-administration of probiotic and selenium on parameters of mental health, hormonal profiles, and biomarkers of inflammation and oxidative stress in women with PCOS. Data on the effects of selenium and probiotic co-supplementation on mental health, hormonal and inflammatory parameters of patients with polycystic ovary syndrome (PCOS) are scarce. This investigation was carried out to evaluate the effects of selenium and probiotic co-supplementation on mental health, hormonal and inflammatory parameters in women with PCOS...
September 14, 2018: Journal of Ovarian Research
Linda S Aglio, Muhammad M Abd-El-Barr, Vwaire Orhurhu, Grace Y Kim, Jie Zhou, Laverne D Gugino, Lisa J Crossley, James L Gosnell, John H Chi, Michael W Groff
OBJECTIVE Preemptive administration of analgesic medication is more effective than medication given after the onset of the painful stimulus. The efficacy of preoperative or preemptive pain relief after thoracolumbosacral spine surgery has not been well studied. The present study was a double-blind, placebo-controlled randomized trial of preemptive analgesia with a single-shot epidural injection in adult patients undergoing spine surgery. METHODS Ninety-nine adult patients undergoing thoracolumbosacral operations via a posterior approach were randomized to receive a single shot of either epidural placebo (group 1), hydromorphone alone (group 2), or bupivacaine with hydromorphone (group 3) before surgery at the preoperative holding area...
September 14, 2018: Journal of Neurosurgery. Spine
Barbara R Cardoso, Blaine R Roberts, Charles B Malpas, Lucy Vivash, Sila Genc, Michael M Saling, Patricia Desmond, Christopher Steward, Rodney J Hicks, Jason Callahan, Amy Brodtmann, Steven Collins, Stephen Macfarlane, Niall M Corcoran, Christopher M Hovens, Dennis Velakoulis, Terence J O'Brien, Dominic J Hare, Ashley I Bush
Insufficient supply of selenium to antioxidant enzymes in the brain may contribute to Alzheimer's disease (AD) pathophysiology; therefore, oral supplementation may potentially slow neurodegeneration. We examined selenium and selenoproteins in serum and cerebrospinal fluid (CSF) from a dual-dose 24-week randomized controlled trial of sodium selenate in AD patients, to assess tolerability, and efficacy of selenate in modulating selenium concentration in the central nervous system (CNS). A pilot study of 40 AD cases was randomized to placebo, nutritional (0...
September 13, 2018: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
Jian-Hui Yan, Bing-Jie Guan, Hai-Yan Gao, Xian-E Peng
BACKGROUND: Clinical trials examining the therapeutic benefit of omega-3 polyunsaturated fatty acids (ω-3 PUFAs) on nonalcoholic fatty liver disease (NAFLD) have reported inconsistent results. We performed a meta-analysis of randomized controlled trials (RCTs) examining the effect of ω-3 PUFA supplementation on NAFLD, and provide substantial evidence on whether ω-3 PUFA supplementation has a favorable effect for treating NAFLD. METHODS: We searched the PubMed, Cochrane Library, Springer Link, China National Knowledge Infrastructure (CNKI), Wanfang, and Chinese Scientific and Technological Journal (VIP) databases for RCTs on oral ω-3 PUFA supplementation in patients with NAFLD...
September 2018: Medicine (Baltimore)
Peng Ju Liu, Fang Ma, Qi Yan Wang, Shu Li He
BACKGROUND/OBJECTIVE: This systematic review aims to determine the potential effects of oral nutritional supplements (ONS) in patients receiving maintenance dialysis therapy (MDT). METHODS: Electronic databases were searched without language limits through to July 2018. Randomized controlled trials (RCTs) that involved comparisons of ONS versus placebo or routine care are included in this meta-analysis. RevMan 5.3 statistical software was used for meta-analysis...
2018: PloS One
Sarah J Borengasser, Peter R Baker, Mattie E Kerns, Leland V Miller, Alexandra P Palacios, Jennifer F Kemp, Jamie E Westcott, Seth D Morrison, Teri L Hernandez, Ana Garces, Lester Figueroa, Jacob E Friedman, K Michael Hambidge, Nancy F Krebs
Elevated branched chain amino acids (BCAAs: valine, leucine, and isoleucine) are well-established biomarkers of obesity-associated insulin resistance (IR). Mounting evidence suggests that low- and middle-income countries are suffering from a "double burden" of both undernutrition (growth stunting) and overnutrition (obesity) as these countries undergo a "nutrition transition". The purpose of this study was to examine if pre-pregnancy body mass index (BMI, kg/m²) and a daily lipid-based micronutrient supplement (LNS, Nutriset) would lead to cross-sectional differences in circulating levels of branched chain amino acids (BCAAs) in Guatemalan women experiencing short stature during early pregnancy...
September 11, 2018: Nutrients
Maria A Choukri, Tamlin S Conner, Jill J Haszard, Michelle J Harper, Lisa A Houghton
Epidemiological evidence has linked low vitamin D status to a range of mood disorders. However, studies examining whether vitamin D supplementation can improve mood-related outcomes in healthy populations are limited. We investigated whether vitamin D supplementation over winter is beneficial for improving mood-related outcomes in healthy women. A total of 152 healthy women (18-40 years) in Dunedin, New Zealand were randomly assigned to receive 50 000 IU (1·25 mg) of oral vitamin D3 or placebo once per month for 6 months...
2018: Journal of Nutritional Science
Guillermo Alberto Mattioli, Diana Esther Rosa, Esteban Turic, Juan Alberto Testa, Raul Martín Lizarraga, Luis Emilio Fazzio
Copper (Cu) and zinc (Zn) deficiency may cause poor weight gain, hematological changes, and immune failure in extensive beef cattle breeding systems. Diagnosis of the deficiency is based on plasma Cu and Zn concentrations; however, there are discrepancies regarding data interpretation. Here, plasma Cu and Zn concentrations are discussed as risk markers. We evaluated the effect of parenteral Cu and Zn supplementation on their plasma concentrations, weight gain, hematological parameters, and antibody titers to bovine herpes virus 1 (BoHV-1)...
September 8, 2018: Biological Trace Element Research
Sahar Dehghani, Elham Alipoor, Ahmad Salimzadeh, Mehdi Yaseri, Mostafa Hosseini, Christine Feinle-Bisset, Mohammad Javad Hosseinzadeh-Attar
BACKGROUND: Osteoarthritis (OA) is a prevalent degenerative joint disease, which is associated with chronic and disabling pain. The adipocytokines, resistin and tumor necrosis factor-alpha (TNF-α), might play a role in OA pathogenesis and outcomes. PURPOSE: The aim of this study was, therefore, to assess the anti-inflammatory and analgesic effects of a garlic supplement on serum resistin and TNF-α concentrations and on pain severity in overweight or obese women with knee OA...
September 15, 2018: Phytomedicine: International Journal of Phytotherapy and Phytopharmacology
Sevgi Ikbali Afsar, Ilkin Mirzayev, Oya Umit Yemisci, Sacide Nur Cosar Saracgil
OBJECTIVE: Virtual reality game system is one of novel approaches, which can improve hemiplegic extremity functions of stroke patients. We aimed to evaluate the effect of the Microsoft Xbox 360 Kinect video game system on upper limb motor functions for subacute stroke patients. METHODS: The study included 42 stroke patients of which 35 (19 Virtual reality group, 16 control group) completed the study. All patients received 60 minutes of conventional therapy for upper extremity, 5 times per-week for 4 weeks...
September 4, 2018: Journal of Stroke and Cerebrovascular Diseases: the Official Journal of National Stroke Association
Fukumi Yoshikawa, Naoki Kumashiro, Fumika Shigiyama, Hiroshi Uchino, Yasuyo Ando, Hiroshi Yoshino, Masahiko Miyagi, Kayoko Ikehara, Takahisa Hirose
AIMS: This study was designed to explore the effects of intermittent use of empagliflozin, a sodium glucose cotransporter 2 inhibitor, on dietary self-management and glycemic control in patients with inadequately controlled type 2 diabetes. MATERIALS AND METHODS: This is a prospective, randomized, open-label, blinded-endpoint, parallel-group, comparative clinical trial of 50 type 2 diabetes patients treated with no more than 3 oral anti-diabetic drugs (HbA1c ≥7...
September 5, 2018: Diabetes, Obesity & Metabolism
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