scholarly journals Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2392
Author(s):  
Yasna K. Palmeiro-Silva ◽  
Raúl I. Aravena ◽  
Lisette Ossio ◽  
Javiera Parro Fluxa
Keyword(s):  
Metabolic Syndrome ◽  
Placebo Group ◽  
Daily Intake ◽  
Aqueous Dispersion ◽  
Blood Parameters ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Double Blind Study ◽  
Daily Consumption ◽  
Double Blind

Metabolic syndrome (MS) affects up to 40% of the population and is associated with heart failure, stroke and diabetes. Phytosterols (PS) could help to manage one or more MS criteria. The purpose of this study was to evaluate the therapeutic effect of daily supplementation of an aqueous dispersion of 2 g of free-phytosterols nanoparticles in individuals with MS over six months of intervention, compared with placebo. This double-blind study included 202 participants with MS randomly assigned into phytosterol (n = 102) and placebo (n = 100) groups. Participants were assessed at baseline, 4, 12 and 24 weeks. General health questions, anthropometric measurements and blood parameters were analysed. At week 24, the proportion of participants with high triglycerides (≥150 mg/dL) in the phytosterol group was 15.65% lower than in the placebo group (p-value = 0.023). Similarly, half of the participants in the phytosterol group decreased their waist circumference up to 4 cm compared with 0 cm in the placebo group (p-value = 0.0001). We reported no adverse effects (diarrhoea or vitamin D reduction); nonetheless, almost 70% of participants in the phytosterol group self-reported an improvement in bowel habits. Daily intake of free-PS nanoparticles improved some MS criteria; therefore, it might be a promising adjuvant therapy for individuals with MS (NCT02969720).

scholarly journals Daily Consumption of a Chocolate Rich in Flavonoids Decreases Cellular Genotoxicity and Improves Biochemical Parameters of Lipid and Glucose Metabolism

2018 ◽  
Author(s):  
Aldo Leyva-Soto ◽  
Linda Ramona Lara-Jacobo ◽  
Lina Natalia Gonzalez-Cobian ◽  
Rocío Alejandra Chavez-Santoscoy
Keyword(s):  
Biochemical Parameters ◽  
Daily Intake ◽  
Dark Chocolate ◽  
Total Phenolic ◽  
Double Blind Study ◽  
Protective Effects ◽  
Daily Consumption ◽  
Double Blind ◽  
Obesity And Diabetes ◽  
Before And After

In recent years, Atherosclerotic Cardiovascular Disease (ACVD), Obesity and Diabetes, have increase exponentially worldwide. In the present work, we evaluate the genoprotective effect of consuming a flavonoids-rich chocolate and the improvement in the biochemical parameters related to the prevention and treatment of cardiovascular risk and metabolic syndrome in young Mexican adults. A randomized, placebo-controlled, double-blind study was undertaken in the Autonomous University of Baja California. The treatments were a daily intake of 2 grams of dark chocolate containing 70% cooca or milk chocolate. Total phenolic compounds and flavonoids were evaluated in both chocolates. Anthropometrical and Biochemical parameters were measured in the 84 participants before and after the study. Buccal epithelial genotoxicity was also evaluated from the beginning to the end of the experiment in the participants. Result suggested that flavonoids of cocoa intake have protective effects against DNA damage, and Biochemical parameters (total cholesterol, triglycerides, and LDL-cholesterol level in blood) and anthropometrical parameters (waist circumference) were also improved after six months of daily intake of 2 grams of dark chocolate with a 70% of cocoa.

Topiramate Augmentation in Resistant OCD: A Double-Blind Placebo-Controlled Clinical Trial

CNS Spectrums ◽  
2010 ◽  
Vol 15 (11) ◽  
pp. 613-617 ◽  
Author(s):  
Arash Mowla ◽  
Abdol Mohammad Khajeian ◽  
Ali Sahraian ◽  
Abdol Hamid Chohedri ◽  
Faramarz Kashkoli
Keyword(s):  
Placebo Group ◽  
Group Versus ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Treatment Resistant ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Day Range

AbstractObjectivesGlutaminergic dysfunction has been shown to be related to the pathphysiology of obsessive-compulsive disorder (OCD). Topiramate is an antiepileptic that inhibits glutaminergic action. The aim of this study is to evaluate the efficacy of topiramate augmentation in patients with treatment resistant OCD.MethodsThis augmentation trial was designed as a 12-week randomized, placebocontrolled, double-blind study. Forty-nine patients suffering from OCD who had failed to respond to at least 12 weeks of treatment of an adequate and stable dose of a selective serotonin reuptake inhibitor (SSRI) were randomly allocated to receive topiramate or placebo plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure. Treatment response was defined as 25 % or more decrease in scores of Y-BOCS. The mean dosage of topiramate was 180.15 mg/day (range 100–200 mg/day).ResultsForty-one patients (20 of 24 in topiramate group; 21 of 25 in placebo group) completed the trial. The topiramate group showed significant improvement over the study period (mean Y-BOCS score at week 12 as compared with baseline: P=.000). Those receiving topiramate experienced a mean decrease of 32.0% in Y-BOCS score, compared with 2.4% decrease for those receiving placebo. Twelve patients in the topiramate group versus no patient in the placebo group were rated as responder.ConclusionThe results of our study demonstrated that topiramate may augment the therapeutic effect of SSRIs in treatment-resistant OCD patients. However, it should be noted that our study is preliminary and larger double-blind studies are needed to confirm these results.

scholarly journals Granisetron Augmentation of Sertraline in Obsessive-Compulsive Disorder: A Double-Blind Placebo-Controlled, Randomized Clinical Trial

2022 ◽  
Author(s):  
Ala Ghobadian ◽  
Saba Mokhtari ◽  
Behnam Shariati ◽  
Leila Kamalzadeh ◽  
Mohsen Shati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Obsessive Compulsive Disorder ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Complete Response ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder

Abstract Background: Medications currently recommended for the treatment of Obsessive-Compulsive Disorder (OCD) usually relieve the severity of symptoms by as much as 20–30%, and satisfactory treatment is obtained in 40–60% of patients with OCD. Nevertheless, the remaining symptoms continue to impair the patients’ function. Therefore, it is necessary to investigate possible strategies to improve the mitigation of symptoms.In this study, the main objective was to examine and investigate the effectiveness of granisetron, which is a serotonin 5-hydroxytryptamine receptor type 3 (5-HT3) antagonist, as an adjunct therapy to selective serotonin reuptake inhibitors, for the purpose of ameliorating OCD symptoms. Methods: fifty-eight patients diagnosed with OCD, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, who had a Yale-Brown obsessive-compulsive scale (Y-BOCS) score of more than 21 were recruited in a double-blinded, parallel-group, placebo-controlled, clinical trial of 10 weeks to receive either granisetron (1 mg twice daily) and sertraline (100 mg daily initially followed by 200 mg daily after week 4) or placebo and sertraline. The primary outcome was OCD symptoms measured by the Y-BOCS.Results: Y-BOCS total score significantly dropped in both groups (28.9 to 17.7 for granisetron and 27.5 to 19.3 for placebo group with a slightly greater drop for granisetron group), while the granisetron group experienced a significantly greater reduction in obsession scores (Greenhouse-Geisser F(2.32,97.57)=4.52,p-value=0.01). Moreover, in comparison with the placebo group, the proportion of the patients showing complete response was considerably higher among the granisetron group (P-value <0.01). No major adverse effects were observed in any of the groups. Conclusion: The results suggest that granisetron augmentation of sertraline may increase the rate of response in patients with moderate to severe non-refractory OCD. Further studies are suggested in this regard.Trial registration: The trial was registered at the Iranian Registry of Clinical Trials on 27/03/2019 (www.irct.ir; IRCT ID: IRCT20170123032145N3).

scholarly journals Multi-Modal Analgesic Technique for Pain Control in Patients Undergoing Diagnostic Gynecological Laparoscopy: Randomized Controlled Clinical Trial

2019 ◽  
Vol 7 (8) ◽  
pp. 1324-1329 ◽  
Author(s):  
Sherin Refaat ◽  
Ashraf Ali Mawgood ◽  
Mohamed Al Sonbaty ◽  
Maged Gamal ◽  
Abdelrazik Ahmed
Keyword(s):  
Recruitment Maneuver ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Double Blind Study ◽  
Double Blind ◽  
Rescue Analgesia ◽  
Gynaecological Laparoscopy ◽  
Significant Difference ◽  
Analgesic Technique ◽  
Pulmonary Recruitment Maneuver

BACKGROUND: Advancement in minimally invasive laparoscopic surgeries make it one of the best choices for both the surgeon and the patient. The anesthesiologist had to improve the techniques used to control post-operative pain. AIM: In this study, we hyposethized that multi-modal analgesic technique which is a combination of two simple techniques (intraperitoneal lidocaine and pulmonary recruitment) allow better result than using only one of them. PATIENTS AND METHOD: This randomised controlled, double-blind study was conducted in Kasr-Alainy hospital, faculty of medicine, Cairo University, Egypt from September 2017 till February 2018. Fifty female patients, scheduled for diagnostic gynecologic laparoscopy were included in the study. Patients were randomly allocated using random computer allocation with numbered closed opaque envelopes into four study group. GM (n = 12): Patients received pulmonary recruitment maneuver and intra-peritoneal Lidocaine, GL (n = 13): Patients received intra-peritoneal Lidocaine, GP (n = 13): Patients received Pulmonary Recruitment Maneuver, GC (n = 12): Patients received passive exsufflation through the port site. In the ward, patients were asked to fulfil a questionnaire about pain severity using (VAS) at 1, 3, 6-hour post-operative both the patients and the anesthesiologist that assess the (VAS) were blind of the patient group RESULTS: Regarding pain score between groups VAS 1 (the primary outcome) was lowest in GM {4.5 (3-5)} in comparison with other groups (P value = 0.015). While VAS 3 & VAS 6 wasn’t statistically significant between groups. Regarding Time of first rescue analgesia; GM {3 (1.75-4)} showed the longest time in between groups (P-value = 0.042). As regard nausea and vomiting; there was no statistically significant difference in in-between groups. CONCLUSION: Application of Multi-modal analgesic technique allows better analgesia for a longer duration than the use of the sole technique for control of abdominal pain in patients undergoing diagnostic gynaecological laparoscopy.

scholarly journals Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 151 (1) ◽  
pp. 214-222
Author(s):  
Irini Lazou Ahrén ◽  
Magnus Hillman ◽  
Elisabet Arvidsson Nordström ◽  
Niklas Larsson ◽  
Titti Martinsson Niskanen
Keyword(s):  
Mixed Model ◽  
Viral Infections ◽  
Total Daily Dose ◽  
Controlled Clinical Trial ◽  
Positive Trend ◽  
Double Blind Study ◽  
Continuous Variables ◽  
Daily Consumption ◽  
Upper Airways ◽  
Double Blind

ABSTRACT Background Viral infections of the upper airways are the most common cause for absence from work or school, and there is evidence for probiotic efficacy in reducing the incidence and severity of these infections. Objectives We aimed to confirm the previously reported beneficial effects of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 against community-acquired common colds and identify a possible mechanism of action. Methods In a double-blind study, healthy adults (18–70 years of age) with at least 4 colds during the last 12 months before recruitment were randomly allocated to consume either probiotics (n = 448; total daily dose of 109 CFU with the 2 strains equally represented) or placebo (n = 450) once daily for 12 weeks. Recruitment took place from October to February during 2013–2016 (over 3 cold seasons). The probiotic impact on the severity of the colds (Wisconsin Upper Respiratory Symptom Survey−21) was the primary endpoint, whereas secondary endpoints included the incidence rate and duration of colds and an analysis of immune markers. Mann-Whitney U test and mixed model were used for the analysis of continuous variables and Fisher´s exact test was used for the analysis of categorical endpoints. Results Symptom severity was not reduced after intake of the probiotic, despite the positive trend seen in the first season. However, significantly fewer colds were experienced in the probiotic group (mean of 1.24 colds) as compared to the placebo group (mean of 1.36 colds; P = 0.044) for subjects reporting at least 1 cold, the incidence of recurring colds was 30% lower (20.8% vs. 29.8%, respectively; P = 0.055), and the use of analgesics was 18% lower (26.3% vs. 32%, respectively; P = 0.07). After 12 weeks, the change from baseline for IFN-γ differed between the groups (mean difference of −7.01; 95% CI, −14.9 to 0.93; P = 0.045). Conclusions Intake of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2 can be protective against multiple colds in adults prone to getting colds. This trial was registered at clinicaltrials.gov as NCT02013934.

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

scholarly journals Effects of Fermented Milk Containing Lacticaseibacillus paracasei Strain Shirota on Constipation in Patients with Depression: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 2238
Author(s):  
Xiaomei Zhang ◽  
Shanbin Chen ◽  
Ming Zhang ◽  
Fazheng Ren ◽  
Yimei Ren ◽  
...  
Keyword(s):  
Mental Illness ◽  
Placebo Group ◽  
Rating Scale ◽  
Controlled Trial ◽  
Fermented Milk ◽  
Daily Consumption ◽  
Double Blind ◽  
Tnf Α ◽  
Significant Difference ◽  
Factor Α

Probiotics have been shown to benefit patients with constipation and depression, but whether they specifically alleviate constipation in patients with depression remains unclear. The aim of this study was to investigate the effect of Lacticaseibacillus paracasei strain Shirota (LcS), formerly Lactobacillus casei strain Shirota, on constipation in patients with depression with specific etiology and gut microbiota and on depressive regimens. Eighty-two patients with constipation were recruited. The subjects consumed 100 mL of a LcS beverage (108 CFU/mL) or placebo every day for 9 weeks. After ingesting beverages for this period, we observed no significant differences in the total patient constipation-symptom (PAC-SYM) scores in the LcS group when compared with the placebo group. However, symptoms/scores in item 7 (rectal tearing or bleeding after a bowel movement) and items 8–12 (stool symptom subscale) were more alleviated in the LcS group than in the placebo group. The Beck Depression Index (BDI) and Hamilton Depression Rating Scale (HAMD) scores were all significantly decreased, and the degree of depression was significantly improved in both the placebo and LcS groups (p < 0.05), but there was no significant difference between the groups. The LcS intervention increased the beneficial Adlercreutzia, Megasphaera and Veillonella levels and decreased the bacterial levels related to mental illness, such as Rikenellaceae_RC9_gut_group, Sutterella and Oscillibacter. Additionally, the interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) levels were significantly decreased in both the placebo and LcS groups (p < 0.05). In particular, the IL-6 levels were significantly lower in the LcS group than the placebo group after the ingestion period (p < 0.05). In conclusion, the daily consumption of LcS for 9 weeks appeared to relieve constipation and improve the potentially depressive symptoms in patients with depression and significantly decrease the IL-6 levels. In addition, the LcS supplementation also appeared to regulate the intestinal microbiota related to mental illness.

Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

2017 ◽  
Vol 41 (S1) ◽  
pp. S415-S415
Author(s):  
A. Mowla
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Primary Outcome Measure ◽  
Controlled Clinical Trial ◽  
Double Blind Study ◽  
Obsessive Compulsive ◽  
Double Blind ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
Competing Interest ◽  
To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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