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Randomized Controlled Trial Supplement

Mustafa Bseikri, Joyce C McCann, Ashutosh Lal, Edward Fong, Kirsten Graves, Alisa Goldrich, Devan Block, Ginny L Gildengoren, Michele Mietus-Snyder, Mark Shigenaga, Jung Suh, Karen Hardy, Bruce N Ames
Asthma in the obese is often severe, difficult to treat, and characterized by less eosinophilic inflammation than asthma in the nonobese. Obesity-associated metabolic dysregulation may be a causal factor. We previously reported that a nutrient- and fiber-dense bar [Children's Hospital Oakland Research Institute (CHORI)-bar], which was designed to fill gaps in poor diets, improved metabolism in healthy overweight/obese (OW/OB) adults. In this pilot trial, OW/OB adolescents with poorly controlled asthma were randomized to weekly nutrition/exercise classes with or without twice-daily CHORI-bar consumption...
July 19, 2018: FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology
Xinyu Hu, Shijiao Cheng, Yuehui Yin, Lin Ning, Liquan Xiang, Yinpin Zhou
BACKGROUND: Supplemental oxygen has been commonly used in the cases of acute coronary syndrome (ACS); however, recent evidence suggests that high-concentration oxygen supplementation and hyperbaric oxygen in ACS patients are associated with adverse cardiovascular effects. OBJECTIVE: The purpose of this article is to systematically review the role of supplemental oxygen therapy in normoxemic patients with ACS. METHODS: A search for randomized controlled trials before November 2017 in biomedical databases was performed, and a total of 6 eligible studies with 7508 participants were identified...
July 18, 2018: Journal of Cardiovascular Nursing
Kevin N Alschuler, Anne Arewasikporn, Ian K Nelson, Ivan R Molton, Dawn M Ehde
PURPOSE/OBJECTIVE: Starting in middle adulthood, individuals living with multiple sclerosis (MS) are confronted with the simultaneous challenge of coping with advancing MS alongside age-related changes. Psychological resilience is thought to play an important role in promoting healthy aging and thus may be important in the context of aging with MS. This study aimed to evaluate whether Everyday Matters, a novel positive psychology program, had a positive effect on resilience and other related outcomes in adults with MS relative to a wait-list control group...
July 19, 2018: Rehabilitation Psychology
Jiali Chen, Hongmei Xie, Daiwen Chen, Bing Yu, Xiangbing Mao, Ping Zheng, Jie Yu, Yuheng Luo, Junqiu Luo, Jun He
Chlorogenic acid (CGA) is a naturally occurring polyphenol in the human diet and plants, exhibiting antioxidant and anti-inflammatory activities. This study was conducted to investigate the effects of CGA on intestinal development and health in weaned pigs. Twenty-four weaned pigs were randomly assigned to two treatments and fed with a basal diet or a basal diet supplemented with 1000 mg/kg CGA. After a 14 d trial, samples were collected. Compared with the control group, CGA supplementation decreased the serum tumor necrosis factor-α, interleukin-6, and interleukin-1βIL-6 concentrations and elevated the serum immunoglobulin G and jejunal secretory immunoglobulin A concentrations...
February 28, 2018: ACS Omega
Somayyeh Asghari, Maryam Rafraf, Laleh Farzin, Mohammad Asghari-Jafarabadi, Seyed-Mostafa Ghavami, Mohammad-Hossein Somi
Purpose: Despite a proposed role for oxidative stress in the pathogenesis of nonalcoholic fatty liver disease (NAFLD), antioxidant approaches have not been sufficiently investigated in human NAFLD management. Resveratrol has been reported to possess a wide range of biological functions, including antioxidant activities. This study aimed to evaluate the effects of resveratrol supplementation on oxidative/anti-oxidative status in patients with NAFLD. Methods: This randomized, double-blind, placebo-controlled clinical trial was conducted on 60 patients with NAFLD (males and females) aged 20 to 60 years, and body mass index (BMI) of 25-35 kg/m2...
June 2018: Advanced Pharmaceutical Bulletin
Gowri Raman, Marissa Shams-White, Esther E Avendano, Fan Chen, Janet A Novotny, Aedin Cassidy
BACKGROUND: There is considerable interest in the impact of increased flavan-3-ol intake on cardiovascular disease (CVD) and diabetes outcomes. Through evidence mapping, we determined the extent of the evidence base to initiate a future systematic review investigating the impact of flavan-3-ol intake on CVD and diabetes outcomes. METHODS: We developed a research protocol, convened a technical expert panel (TEP) to refine the specific research questions, conducted a systematic search in multiple databases, double-screened abstracts and full-text articles, performed data extractions, and synthesized the data...
July 18, 2018: Systematic Reviews
Asmaa S Abdelhamid, Nicole Martin, Charlene Bridges, Julii S Brainard, Xia Wang, Tracey J Brown, Sarah Hanson, Oluseyi F Jimoh, Sarah M Ajabnoor, Katherine Ho Deane, Fujian Song, Lee Hooper
BACKGROUND: Evidence on the health effects of total polyunsaturated fatty acids (PUFA) is equivocal. Fish oils are rich in omega-3 PUFA and plant oils in omega-6 PUFA. Evidence suggests that increasing PUFA-rich foods, supplements or supplemented foods can reduce serum cholesterol, but may increase body weight, so overall cardiovascular effects are unclear. OBJECTIVES: To assess effects of increasing total PUFA intake on cardiovascular disease and all-cause mortality, lipids and adiposity in adults...
July 18, 2018: Cochrane Database of Systematic Reviews
Asmaa S Abdelhamid, Tracey J Brown, Julii S Brainard, Priti Biswas, Gabrielle C Thorpe, Helen J Moore, Katherine Ho Deane, Fai K AlAbdulghafoor, Carolyn D Summerbell, Helen V Worthington, Fujian Song, Lee Hooper
BACKGROUND: Researchers have suggested that omega-3 polyunsaturated fatty acids from oily fish (long-chain omega-3 (LCn3), including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)), as well as from plants (alpha-linolenic acid (ALA)) benefit cardiovascular health. Guidelines recommend increasing omega-3-rich foods, and sometimes supplementation, but recent trials have not confirmed this. OBJECTIVES: To assess effects of increased intake of fish- and plant-based omega-3 for all-cause mortality, cardiovascular (CVD) events, adiposity and lipids...
July 18, 2018: Cochrane Database of Systematic Reviews
Lee Hooper, Lena Al-Khudairy, Asmaa S Abdelhamid, Karen Rees, Julii S Brainard, Tracey J Brown, Sarah M Ajabnoor, Alex T O'Brien, Lauren E Winstanley, Daisy H Donaldson, Fujian Song, Katherine Ho Deane
BACKGROUND: Omega-6 fats are polyunsaturated fats vital for many physiological functions, but their effect on cardiovascular disease (CVD) risk is debated. OBJECTIVES: To assess effects of increasing omega-6 fats (linoleic acid (LA), gamma-linolenic acid (GLA), dihomo-gamma-linolenic acid (DGLA) and arachidonic acid (AA)) on CVD and all-cause mortality. SEARCH METHODS: We searched CENTRAL, MEDLINE and Embase to May 2017 and clinicaltrials...
July 18, 2018: Cochrane Database of Systematic Reviews
Tadashi Akiba, Toshiaki Morikawa, Makoto Odaka, Takeo Nakada, Noriki Kamiya, Makoto Yamashita, Mitsuo Yabe, Takuya Inagaki, Hisatoshi Asano, Shohei Mori, Yo Tsukamoto, Mitsuyoshi Urashima
Higher serum 25-hydroxyvitamin D (25(OH)D) levels are reportedly associated with better survival in early-stage non-small-cell lung cancer (NSCLC). Therefore, whether vitamin D supplementation can improve the prognosis of NSCLC patients was examined (UMIN000001869). 
 Experimental Design: A randomized, double-blind trial comparing vitamin D supplements (1,200 IU/day) with placebo for 1 year after operation was conducted. The primary and secondary outcomes were relapse-free survival (RFS) and overall survival (OS), respectively...
July 17, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Mehdi Koushki, Nasrin Amiri Dashatan, Reza Meshkani
PURPOSE: The evidence has suggested that resveratrol has anti-inflammatory effect; however, the results are inconsistent and inconclusive. The aim of this study was to assess the effect of resveratrol supplementation on the levels of inflammatory markers through a systematic review and meta-analysis of available randomized controlled trials (RCTs). METHODS: A search strategy was completed using Medline, ISI Web of Science, Directory of Open Access Journal, SID, ProQuest, Cochrane Library, Scopus, and EMBASE up to May 2017, to identify placebo-controlled RCTs that assessed resveratrol effects on circulating (serum and plasma) inflammatory markers (interleukin [IL]-6, tumor necrosis factor-α [TNF-α], and high-sensitivity C-reactive protein [hs-CRP]) among adult participants aged 17years and older in 17 RCTs with a total of 736 subjects...
July 12, 2018: Clinical Therapeutics
Fahimeh Haghighatdoost, Mitra Hariri
BACKGROUND: Resveratrol as a polyphenolic compound might be able to reduce inflammatory mediators. Change in inflammatory state is identified by the measurement of inflammatory mediators such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP). The objective of this study is to conduct a systematic review and meta-analysis on randomized controlled trials that assessed the effect of resveratrol on concentration of serum inflammatory mediators. METHOD: Systematic search was performed up to October 2017 using ISI web of science, PubMed, Scopus, EMBASE, and Google scholar...
July 16, 2018: European Journal of Clinical Nutrition
Seyed Mohammad Mousavi, Kurosh Djafarian, Abbas Mojtahed, Hamed Kord Varkaneh, Sakineh Shab-Bidar
Previous studies have shown zinc has potential anti-inflammatory and anti-oxidative effects. However, findings from clinical trials about the effect of zinc on plasma C-reactive protein (CRP) appeared inconsistent and uncertain. Therefore, the aim of this meta-analysis was to summarize the effect of zinc supplementation on plasma CRP concentrations in adults. The literature search through PubMed, SCOPUS, and Google Scholar were done to find published studies up to October 2017. Random or fixed-effects model depending on the results of heterogeneity tests were used to estimate the pooled effect size...
July 13, 2018: European Journal of Pharmacology
Mardin Rashid, Adrie J M Verhoeven, Monique T Mulder, Reinier Timman, Yvonne van Beek-Nieuwland, Athumani A Athumani, Adrienne A M Zandbergen, Hans E van der Wiel, Eric J G Sijbrands, Kirsten A Berk
BACKGROUND: Patients with type 2 diabetes mellitus (T2D) are prone to micro- and macro-vascular complications. Monomeric and oligomeric flavanols (MOF) isolated from grape seeds (Vitis vinifera) have been linked to improved endothelial function and vascular health. The aim of this study is to determine the effect of a daily supplementation of 200 mg MOF on renal endothelial function of patients with T2D and microalbuminuria. METHODS/DESIGN: For this double-blind, placebo-controlled, randomized, multicenter trial 96 individuals (ages 40-85 years) with T2D and microalbuminuria will be recruited...
July 16, 2018: Trials
Zhiying Zhang, Nga T Tran, Tu S Nguyen, Lam T Nguyen, Yatin Berde, Siew Ling Tey, Yen Ling Low, Dieu T T Huynh
BACKGROUND: Maternal nutrition during pregnancy and breastfeeding is important for the healthy growth and development of the fetus and infant. PURPOSE: This study aimed to evaluate the long-term effects of a maternal milk supplementation (MMS) in conjunction with a breastfeeding support program on breastfeeding practices including duration of any breastfeeding and exclusive breastfeeding and child neurodevelopment outcomes at 30 months old. METHODS: We followed up the offspring of 204 Vietnamese women who completed a randomized controlled trial where the intervention group received MMS with a breastfeeding support program from the last trimester to 12 weeks postpartum while the control group received standard care...
2018: PloS One
Courtney M Peterson, Robbie A Beyl, Kara L Marlatt, Corby K Martin, Kayanush J Aryana, Maria L Marco, Roy J Martin, Michael J Keenan, Eric Ravussin
Background: Type 2 resistant starch (RS2) has been shown to improve glycemic control and some cardiovascular endpoints in rodent and human studies. Objective: The aim of this study was to perform one of the first randomized clinical trials in adults with prediabetes and one of the longest trials to test whether RS2 can improve cardiometabolic health. Design: 68 overweight [body mass index (BMI) ≥27 kg/m2] adults aged 35-75 y with prediabetes were randomized to consume 45 g/d of high-amylose maize (RS2) or an isocaloric amount of the rapidly digestible starch amylopectin (control) for 12 wk...
July 12, 2018: American Journal of Clinical Nutrition
Esmaeil Youseif Rad, Ebrahim Falahi, Mahmoud Djalali, Amir Abbasnezhad, Mehdi Brijandi, Somayeh Saboori
Vitamin E can reduce the level of lipid peroxidation and the related markers such as urine and plasma levels of isoprostanes. However, effects of vitamin E supplementation on plasma and urine level of isoprostane F2α as markers of lipid peroxidation were conflicting in various clinical trials. The current meta-analysis was carried out to determine the effects of vitamin E supplementation on plasma and urine levels of isoprostanes F2α in randomized clinical trials. A systematic search of RCTs was carried out in PubMed, Scopus, Science Direct and Cochrane Library databases...
July 16, 2018: International Journal for Vitamin and Nutrition Research. Journal International de Vitaminologie et de Nutrition
Rafaella Cristhine Pordeus Luna, Mayara Karla Dos Santos Nunes, Mussara Gomes Cavalcante Alves Monteiro, Cássia Surama Oliveira da Silva, Rayner Anderson Ferreira do Nascimento, Raquel Patrícia Ataíde Lima, Flávia Cristina Fernandes Pimenta, Naila Francis Paulo de Oliveira, Darlene Camati Persuhn, Aléssio Tony Cavalcanti de Almeida, Alcides da Silva Diniz, Cristina Wide Pissetti, Rodrigo Pinheiro Toledo Vianna, Flavia Emília Leite de Lima Ferreira, Maria da Conceição Rodrigues Gonçalves, Maria José de Carvalho Costa
Background: Excess weight is a strong risk factor for the development of dysglycaemia. It has been suggested that changes in the metabolism microRNAs, small non-coding RNAs that regulate gene expression, could precede late glycaemic changes. Vitamin E in turn may exert important functions in methylation and gene expression processes. This study aimed to determine the effect of α-tocopherol on glycaemic variables and miR-9-1 and miR-9-3 promoter DNA methylation in overweight women. Methods: A randomized, double-blind, exploratory, placebo-controlled study was conducted in overweight and obese adult women ( n  = 44) who ingested synthetic vitamin E (all-rac-α-tocopherol), natural source vitamin E (RRR-rac-α-tocopherol) or placebo capsules and were followed up for a period of 8 weeks...
2018: Nutrition & Metabolism
Storm N S Reid, Je-Kwang Ryu, Yunsook Kim, Byeong Hwan Jeon
Considering the neuroprotective and antioxidant potential of fermented Laminaria japonica A. (FST), the purpose of the present study is to establish whether FST may be considered a viable, efficacious supplement that can be administered in later life to offset neurodegenerative conditions associated with aging. Forty senior subjects participated in a randomized, double-blind, and placebo-controlled study. Two groups were formed, one FST group (n = 32, 72.35 ± 5.54 yrs) and one placebo (CON) (n = 28, 74.57 ± 5...
2018: Evidence-based Complementary and Alternative Medicine: ECAM
Jenny Guidi, Eva-Lotta Brakemeier, Claudi L H Bockting, Fiammetta Cosci, Pim Cuijpers, Robin B Jarrett, Michael Linden, Isaac Marks, Charles S Peretti, Chiara Rafanelli, Winfried Rief, Silvia Schneider, Ulrich Schnyder, Tom Sensky, Elena Tomba, Carmelo Vazquez, Eduard Vieta, Stephan Zipfel, Jesse H Wright, Giovanni A Fava
Recent years have seen major developments in psychotherapy research that suggest the need to address critical methodological issues. These recommendations, developed by an international group of researchers, do not replace those for randomized controlled trials, but rather supplement strategies that need to be taken into account when considering psychological treatments. The limitations of traditional taxonomy and assessment methods are outlined, with suggestions for consideration of staging methods. Active psychotherapy control groups are recommended, and adaptive and dismantling study designs offer important opportunities...
July 13, 2018: Psychotherapy and Psychosomatics
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