scholarly journals Effects of Dietary Intervention on Gut Microbiota and Metabolic-Nutritional Profile of Outpatients with Non-Alcoholic Steatohepatitis: a Randomized Clinical Trial

2019 ◽  
Vol 28 (3) ◽  
pp. 279-287 ◽  
Author(s):  
Fabiana De Faria Ghetti ◽  
Daiane Gonçalves De Oliveira ◽  
Juliano Machado De Oliveira ◽  
Lincoln Eduardo Villela Vieira de Castro Ferreira ◽  
Dionéia Evangelista Cesar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Gut Microbiota ◽  
Randomized Clinical Trial ◽  
Bacterial Overgrowth ◽  
Diet Group ◽  
Control Group ◽  
Model Assessment ◽  
Nutritional Profile ◽  
Alcoholic Steatohepatitis ◽  
The Impact

Background & Aims: Modulation of the gut microbiota emerges as a therapeutic possibility to improve health. Our objective was to compare the impact of three months of intervention with diet plus nutritional orientation versus only nutritional orientation on the gut microbiota and metabolic-nutritional profile of outpatients with non-alcoholic steatohepatitis. Methods: It was a randomized clinical trial with 40 outpatients (49.48 ± 10.3 years), allocated in two groups: DIET group (n=20), who received diet (1.651.34 ± 263.25 kcal; 47% carbohydrates, 28% lipids, 25% proteins, 30 g fibers) and nutritional orientation, and control group (n = 20), which received only nutritional orientation. Results: The DIET group, in relation to baseline, presented a reduction in body weight (p<0.001), BMI (p<0.001), waist circumference (p=0.001), percentage of fat (p=0.002), serum aspartate aminotransferase (p<0.001), alanine aminotransferase (p<0.001), γ-glutamyltransferase (p=0.001), glycemia (p=0.003), homeostasis model assessment of insulin resistance (p=0.017), total cholesterol (p=0.014), and triacylglycerols (p=0.008), whereas the control group did not present changes. After intervention, the small intestinal bacterial overgrowth frequency was 30% in the DIET group and 45% in the control group (p=0.327). In the DIET group, an increase in the density of total microorganisms (3.76 ± 7.17 x 10 8 cells g -1 ; p=0.048) was detected, while in the control group reduced Bacteroidetes (-0.77 ± 2.01 x 10 8 cells g -1 , p=0.044) and Verrucomicrobiales (-0.46 ± 0.75 x 10 8 cells g -1 ; p=0.022) were observed. Conclusions: The results suggest that exclusively dietary modifications contribute to health promotion in non-alcoholic steatohepatitis and should be the basis of nutritional treatment for this condition.

scholarly journals Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial

2017 ◽  
Vol 18 (12) ◽  
pp. 1112-1116
Author(s):  
A Nishad ◽  
NS Sreesan ◽  
Joseph Joy ◽  
Lakshmi Lakshmanan ◽  
Joyce Thomas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Antibacterial Activity ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Orthodontic Appliances ◽  
Group I ◽  
Fixed Orthodontic Appliances ◽  
Significant Difference ◽  
The Impact ◽  
Experimental Group

ABSTRACT Aim The study aimed to assess the impact of mouthwashes on antibacterial activity of individuals with fixed orthodontic appliances. Materials and methods A total of 60 individuals were considered in the study. Sixty (20 each group) nonextraction class I individuals were randomly divided into experimental and control groups. Group I: Experimental group [chlorhexidine (CHX) mouthwash], group II: Experimental group (neem mouthwash), group III: Control group (distilled water). All the clinical examinations were done at baseline and 30th day respectively, after the start of orthodontic treatment. The mean differences between the different experimental groups were calculated using one-way analysis of variance (ANOVA) test. Results There was no statistical significance at baseline mean plaque index (PI), gingival index (GI) scores, and Streptococcus mutans (SM) colony count between groups. The PI and GI scores among CHX and neem mouthwash groups (p = 0.002, p = 0.032 respectively) were significantly reduced after intervention and also the SM colonies count was reduced in CHX and neem mouthwash groups and there was significant difference between the groups. Conclusion As both mouthwashes showed significant effectiveness on antibacterial activity in individuals with fixed orthodontic appliances, neem mouthwash can be used as an alternative to CHX. Clinical significance It is better to have a sound knowledge regarding the use of mouthwash in long term as fixed orthodontics are associated with accumulation of SM, enamel demineralization, and an increased number of carious lesions, predominantly in sites adjacent to bracket. How to cite this article Nishad A, Sreesan NS, Joy J, Lakshmanan L, Thomas J, Anjali VA. Impact of Mouthwashes on Antibacterial Activity of Subjects with Fixed Orthodontic Appliances: A Randomized Clinical Trial. J Contemp Dent Pract 2017;18(12):1112-1116.

scholarly journals Interleukin-31 Serum And Pruritus Dimension After Acupuncture Treatment In Hemodialysis Patients: A Randomized Clinical Trial

2021 ◽  
Vol 9 (B) ◽  
pp. 196-201
Author(s):  
Dedi Ardinata ◽  
Rozaimah Zain-Hamid ◽  
Irma. D. Roesyanto-Mahadi ◽  
Hasan Mihardja
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Serum Levels ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Placebo Control ◽  
Limited Information ◽  
Before And After ◽  
The Impact

BACKGROUND: Interleukin (IL)-31 serum levels were significantly higher in hemodialysis patients with pruritus, whereas acupuncture in LI11 was shown to improve symptoms of pruritus. However, there is limited information that IL-31 serum levels that correlate with decreased dimensions of the pruritus after acupuncture in LI11 in a hemodialysis patient. AIM: The aim of the study was to demonstrate the impact of acupuncture in LI11 and IL-31 serum level and its correlation with dimensions of the pruritus in hemodialysis patients. METHODS: A randomized clinical trial has been carried out from August 2019 to December 2019 at H. Adam Malik General Hospital, Medan, Indonesia. Sixty patients underwent hemodialysis who were randomly allocated to two groups, one group got acupuncture in Quchi LI11 (intervention group), and the other group got a placebo (control group). IL-31 serum levels and pruritus were measured before and after 6 weeks of acupuncture in both groups. RESULTS: Acupuncture did not significantly reduce IL-31 (p = 0.931) and decreased dimensions: Degree, duration, disability, and distribution of the pruritus between the intervention group and the control group after 6 weeks of acupuncture in LI11. It can be shown that there is no significant correlation between IL-31 serum levels and dimensions of the pruritus. CONCLUSION: This study demonstrates the effect of acupuncture on reducing dimensions of the pruritus not related to IL-31 serum levels. Identifying the action mechanism of acupuncture to minimize pruritus considerably enhances knowledge of the impacts of acupuncture on reducing pruritus in hemodialysis patients.

scholarly journals The Impact of Involvement of Father's with Preterm Newborns on their Paternal-Infant Bonding and Self-Efficacy: non-randomized clinical trial

2020 ◽  
Author(s):  
Jila Mirlashari ◽  
Liisa Holsti ◽  
Hadi Ranjbar ◽  
Mahnaz Sanjari ◽  
Fatemeh Morovati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Self Efficacy ◽  
Repeated Measures ◽  
Intervention Group ◽  
T Test ◽  
Control Group ◽  
Developmental Care ◽  
Premature Newborns ◽  
The Impact

Abstract Background: Premature birth and postpartum hospitalization can hurt the father-newborn bonding and fathers’ self-efficacy in the care of the newborn. This study was conducted to investigate the effect of the involvement of fathers with premature newborns on paternal-infant bonding and self-efficacy based on developmental care principles.Methods: This was a non-randomized clinical trial. Eighty fathers of hospitalized newborns in the neonatal intensive care unit were selected by convenience sampling method and divided into two groups ( 1 ). The intervention comprised training developmental care to fathers through simulations and then at the bedside of the newborn and the active involvement of fathers in the care of premature newborns admitted to the NICU. Pre-and post-intervention outcomes (after four weeks) were collected using Mother to Infant Bonding Scale and Perceived Maternal Parenting Self-Efficacy tool. Differences between groups were analyzed using independent t-test, paired t-test, repeated measures ANOVA.Results: The mean bonding score reduced by 2.3 ± 2.17 in the control group and 5.27 ± 2. 57 in the intervention group. A lower score represents a better bonding (f (1.78) = 9.19, p = 0.003). The self-efficacy score increased in both groups however, it was significantly higher in intervention group. In the intervention group increased by 8.85 ± 5.046, and in the control group, it increased by 1.27± 3.31, (f (1.78) = 21.88, p <0.001).Conclusions: Developmental care by fathers training and involvement in care can improve the father -infant bonding and increase the paternal self-efficacy for the care of the high risk newborn.Trial registration: Iranian Registry of Clinical Trials: IRCT20171010036690N1, 2018-01-31.

The impact of moderate combination exercise on HbA1c, IL-6, and TNF in type 2 diabetic and non-diabetic subjects: an interventional non-randomized clinical trial

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Bandar Alharbi ◽  
Nawal Alsubaie ◽  
Tarsem S. Sahota ◽  
M. Joan Taylor
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Weight Reduction ◽  
Exercise Session ◽  
Pharmacological Intervention ◽  
Control Group ◽  
Combined Exercise ◽  
The Impact ◽  
Type 2 Diabetic

Introduction: The main causes of worldwide increase in prevalence of type 2 diabetes are the daily consumption of excessive number of calories and sedentary lifestyle. Diabetes is usually accompanied by hypertension, lipid disorders and obesity that are considered as risk factors for developing diabetes. This study is designed to assess the benefit of a combined exercise programme (cardio “aerobic” and resistance) on HbA1c and the inflammatory markers (IL-6, and TNF) in type 2 diabetic (T2D) and non-diabetic (ND) subjects. Materials and methods: This is an interventional non randomized clinical trial conducted from 2016 to 2019 at exercise physiology laboratory at De Montfort University (DMU). Our target volunteers are T2D (HbA1c > 6.4), and ND (HbA1c < 5.8) with age group from 18-60 years old who are fit and able to do exercise. No restriction on weight. HbA1c, weight, BMI, waist and lung capacity were measured at baseline and at the 12th exercise session. In each exercise session the participant performed a combined exercise program consists of 30 min of resistance exercise followed by 20 min moderate cycling to be done twice a week for 6 weeks. Results: We enrolled 17 T2D intervention group 4 female and 13 male and 8 ND control group 5 female and 3 male. In both groups there was a significant reduction in HbA1c level after 6 weeks (P= 0.000). In T2D there were a significant weight reduction that decreased from (92.0± 4.3) to (90.0±4.5), (P< 0.001), BMI reduction that decreased from (30.8± 1.0) to (30.2± 0.9), (P< 0.001). In ND, the changes in weight reduction and BMI level were not significant. In T2D the changes in IL-6 level were only significant after the last exercise session. It was increased from 1.79±0.4 to 3.88±1.9 pg/ml (P=0.002), while it was not significant in ND group. In T2D and ND subjects, the changes in TNF level were insignificant. Conclusion: Development of combination exercise programs as a non-pharmacological intervention for diabetic and non-diabetic population are essential to decrease the prevalence of diabetes worldwide. In addition to conduction of public awareness events for proper implementation.

scholarly journals Modulation of Gut Microbiota and Oxidative Status by β-Carotene in Late Pregnant Sows

2020 ◽  
Vol 7 ◽  
Author(s):  
Xupeng Yuan ◽  
Jiahao Yan ◽  
Ruizhi Hu ◽  
Yanli Li ◽  
Ying Wang ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Dietary Supplementation ◽  
Basal Diet ◽  
Fecal Microbiota ◽  
Control Group ◽  
Metabolic Activities ◽  
The Impact ◽  
Positive Effect ◽  
Β Carotene

Recent evidences suggest that gut microbiota plays an important role in regulating physiological and metabolic activities of pregnant sows, and β-carotene has a potentially positive effect on reproduction, but the impact of β-carotene on gut microbiota in pregnant sows remains unknown. This study aimed to explore the effect and mechanisms of β-carotene on the reproductive performance of sows from the aspect of gut microbiota. A total of 48 hybrid pregnant sows (Landrace × Yorkshire) with similar parity were randomly allocated into three groups (n = 16) and fed with a basal diet or a diet containing 30 or 90 mg/kg of β-carotene from day 90 of gestation until parturition. Dietary supplementation of 30 or 90 mg/kg β-carotene increased the number of live birth to 11.82 ± 1.54 and 12.29 ± 2.09, respectively, while the control group was 11.00 ± 1.41 (P = 0.201). Moreover, β-carotene increased significantly the serum nitric oxide (NO) level and glutathione peroxidase (GSH-Px) activity (P &lt; 0.05). Characterization of fecal microbiota revealed that 90 mg/kg β-carotene increased the diversity of the gut flora (P &lt; 0.05). In particular, β-carotene decreased the relative abundance of Firmicutes including Lachnospiraceae AC2044 group, Lachnospiraceae NK4B4 group and Ruminococcaceae UCG-008, but enriched Proteobacteria including Bilophila and Sutterella, and Actinobacteria including Corynebacterium and Corynebacterium 1 which are related to NO synthesis. These data demonstrated that dietary supplementation of β-carotene may increase antioxidant enzyme activity and NO, an important vasodilator to promote the neonatal blood circulation, through regulating gut microbiota in sows.

scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

Pharmacological Therapy Determines the Gut Microbiota Modulation by a Pomegranate Extract Nutraceutical in Metabolic Syndrome: A Randomized Clinical Trial

2021 ◽  
pp. 2001048
Author(s):  
Adrián Cortés‐Martín ◽  
Carlos Eduardo Iglesias‐Aguirre ◽  
Amparo Meoro ◽  
María Victoria Selma ◽  
Juan Carlos Espín
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Gut Microbiota ◽  
Randomized Clinical Trial ◽  
Pharmacological Therapy

scholarly journals Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Respiratory Rate ◽  
Randomized Clinical Trial ◽  
Protective Ventilation ◽  
Adult Patients ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Neurosurgical Patients

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

Sign in / Sign up

Export Citation Format

Share Document