scholarly journals Decrease in Salivary Serotonin in Response to Probiotic Supplementation With Saccharomyces boulardii in Healthy Volunteers Under Psychological Stress: Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Michał Seweryn Karbownik ◽  
Joanna Kręczyńska ◽  
Anna Wiktorowska-Owczarek ◽  
Paulina Kwarta ◽  
Magdalena Cybula ◽  
...  
Keyword(s):  
Psychological Stress ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Saccharomyces Boulardii ◽  
Eating Attitudes ◽  
Stressful Event ◽  
Serotonin Concentration ◽  
Double Blind ◽  
Cognitive Action ◽  
Study Participants

BackgroundBacterial probiotics are thought to exert a serotonergic effect relevant to their potential antidepressant and pro-cognitive action, but yeast probiotics have not been tested. The aim of the present study was to determine whether 30-day supplementation with Saccharomyces boulardii affects the level of salivary serotonin under psychological stress and identify the factors associated with it.MethodsHealthy medical students were randomized to ingest Saccharomyces boulardii CNCM I-1079 or placebo before a stressful event. Salivary serotonin concentration was assessed before and at the end of supplementation. Moreover, obtained results were compared to psychological, biochemical, physiological and sociodemographic study participants data.ResultsData of thirty-two participants (22.8 ± 1.7 years of age, 16 males) was available for the main analysis. Supplementation with Saccharomyces boulardii decreased salivary serotonin concentration under psychological stress by 3.13 (95% CI 0.20 to 6.07) ng/mL, p = 0.037, as compared to placebo. Salivary serotonin was positively correlated with salivary metanephrine (β = 0.27, 95% CI 0.02 to 0.52, p = 0.031) and pulse rate (β = 0.28, 95% CI 0.05 to 0.50, p = 0.018), but insignificantly with anxiety, depression, eating attitudes and information retrieval.ConclusionsSaccharomyces boulardii CNCM I-1079 may be distinct from bacterial probiotics in its salivary serotonergic effect, which appears positively linked to symapathoadrenal markers. The study requires cautious interpretation, and further investigation.

scholarly journals Salivary Serotonin Decrease in Response to Probiotic Supplementation with Saccharomyces boulardii in Healthy Volunteers under Psychological Stress: Secondary Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Michal Seweryn Karbownik
Keyword(s):  
Psychological Stress ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Saccharomyces Boulardii ◽  
Eating Attitudes ◽  
Stressful Event ◽  
Serotonin Concentration ◽  
Double Blind ◽  
Cognitive Action ◽  
Study Participants

(1) Background: Bacterial probiotics are thought to exert a serotonergic effect relevant to their potential antidepressant and pro-cognitive action, but yeast probiotics have not been tested. The aim of the present study was to determine whether 30-day supplementation with Saccharomyces boulardii affects the level of salivary serotonin under psychological stress and identify the factors associated with it. (2) Methods: Healthy medical students were randomized to ingest Saccharomyces boulardii CNCM I-1079 or placebo before a stressful event. Salivary serotonin concentration was assessed before and at the end of supplementation. Moreover, obtained results were compared to psychological, biochemical, physiological and sociodemographic study participants data. (3) Results: Data of thirty-two participants (22.8 ± 1.7 years of age, 16 males) was available for the main analysis. Supplementation with Saccharomyces boulardii decreased salivary serotonin concentration under psychological stress by 3.13 (95% CI 0.20 to 6.07) ng/mL, p = 0.037, as compared to placebo. Salivary serotonin was positively correlated with salivary metanephrine (β = 0.27, 95% CI 0.02 to 0.52, p = 0.031) and pulse rate (β = 0.28, 95% CI 0.05 to 0.50, p = 0.018), but insignificantly with anxiety, depression, eating attitudes and information retrieval. (4) Conclusions: Saccharomyces boulardii CNCM I-1079 may be distinct from bacterial probiotics in its salivary serotonergic effect, which appears positively linked to symapathoadrenal markers. The study requires cautious interpretation, and further investigation.

scholarly journals Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial

2017 ◽  
Vol 14 (5) ◽  
pp. 737-741 ◽  
Author(s):  
Ari Moskowitz ◽  
Lars W. Andersen ◽  
Michael N. Cocchi ◽  
Mathias Karlsson ◽  
Parth V. Patel ◽  
...  
Keyword(s):  
Septic Shock ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Protective Agent ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Efficacy of colchicine in moderately symptomatic COVID-19 patients: a study protocol for a double-blind, randomized, placebo-controlled trial

2021 ◽  
Vol 8 (1) ◽  
pp. 43
Author(s):  
Motlabur Rahman ◽  
Mujibur Rahman ◽  
Ponkaj K. Datta ◽  
Khairul Islam ◽  
Pratyay Hasan ◽  
...  
Keyword(s):  
Standard Treatment ◽  
Controlled Trial ◽  
Ordinal Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
College Hospital ◽  
Medical College ◽  
The Status ◽  
Anti Inflammatory ◽  
Study Participants

<p class="abstract"><strong>Background:</strong> Inflammation is playing a major role in the pathophysiology of severe COVID-19 disease. The main causes of mortality are cytokine syndrome and immune thromboembolism. Colchicine is an anti-inflammatory drug but its action is mediated by completely different pathophysiologic routes than that of corticosteroids and non-steroidal anti-inflammatory agents. Colchicine inhibits neutrophil chemotaxis, inhibits inflammasome signaling and reduces interleukin-1β, reduces neutrophil-platelet interaction and aggregation. Colchicine is a readily available, cheap drug, has been used safely for many years. Specific targeted anti-inflammatory drugs like tocilizuma and anakinra are costly. A previous study suggested a significant clinical benefit from colchicine in patients hospitalized with COVID-19. But they did not compare with placebo. So, we have designed this study.</p><p class="abstract"><strong>Methods:</strong> This is a prospective, double-blind, randomized, placebo-controlled clinical trial. The study will be conducted at Dhaka medical college hospital, Bangladesh. Real time-polymerase chain reaction (RT-PCR) positive COVID-19 patients with moderate symptoms will be included in this study. Participants will be randomized into two groups at 1:1 ratio. Patients of one group will be treated with standard treatment along with colchicine for 14 days. The patients in other group will be treated with standard treatment along with placebo for the same duration. The primary outcome of the study will be time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a seven-category ordinal scale.</p><p class="abstract"><strong>Conclusions: </strong>Enrolment of participants has begun at the study site. A total of 300 participants will be enrolled.</p><p class="abstract"><strong>Trial Registration:</strong> ClinicalTrials.gov identifier: NCT04527562.</p>

scholarly journals Design and rationale of randomized, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis

2021 ◽  
pp. 00054-2021
Author(s):  
Evans R. Fernández Pérez ◽  
James L. Crooks ◽  
Jeffrey J. Swigris ◽  
Joshua J. Solomon ◽  
Michael P. Mohning ◽  
...  
Keyword(s):  
Hypersensitivity Pneumonitis ◽  
Controlled Trial ◽  
Lung Parenchyma ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Secondary Endpoints ◽  
The Mean ◽  
Predicted Values ◽  
Study Participants ◽  
To Receive

Hypersensitivity pneumonitis (HP) is an immunologically mediated form of lung disease resulting from inhalational exposure to any of a large variety of antigens. A subgroup of patients with HP develops pulmonary fibrosis (fibrotic HP, FHP), a significant cause of morbidity and mortality. This study will evaluate the safety and efficacy of the antifibrotic pirfenidone in treating FHP.This single-center, randomized, double-blind, placebo-controlled trial is enrolling adults with FHP (ClinicalTrials.gov: NCT02958917). Study participants must have fibrotic abnormalities involving ≥5% of the lung parenchyma on high-resolution CT scan, forced vital capacity ≥40% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg·d−1 or placebo. The primary efficacy endpoint is the mean change in %FVC from baseline to week 52. A number of secondary endpoints have been chosen to evaluate the safety and efficacy in different domains.

scholarly journals Biomarkers of Docosahexaenoic Acid but Not Arachidonic Acid Reflect Dietary Intakes in Toddlers at Ages 1 and 2 Years Who Are Not Meeting Dietary Recommendations

2019 ◽  
Vol 150 (3) ◽  
pp. 518-525
Author(s):  
Alejandra M Wiedeman ◽  
Roger A Dyer ◽  
Deanna McCarthy ◽  
Karin Yurko-Mauro ◽  
Sheila M Innis ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Arachidonic Acid ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Dietary Intakes ◽  
Dietary Recommendations ◽  
Double Blind ◽  
Dietary Pufa ◽  
Food Records ◽  
Epa And Dha

ABSTRACT Background Long-chain n–6 and n–3 PUFAs are important for growth and development. However, little is known about requirements and current dietary intakes of these fatty acids in toddlers. Objectives This study assessed dietary intakes of n–6 and n–3 PUFAs and determined the relation to circulating PUFAs in toddlers at ages 1 and 2 y. Methods This is a secondary analysis of data from toddlers enrolled in a double-blind randomized controlled trial of arachidonic acid (ARA) and DHA supplementation between ages 1 and 2 y. Dietary intakes of fatty acids were estimated by 3-d food records, and fatty acid composition in plasma total phospholipids, red blood cell phosphatidylethanolamine (PE), and phosphatidylcholine (PC) were assessed by GC at baseline in all subjects (n = 110; mean age 1.12 y; 64% male) and in the control subjects at 2 y (n = 43). Results The dietary intakes of ARA, EPA, and DHA at age 1 y (baseline) were [mean (median)] 36.8 (30.0), 16.0 (0.00), and 31.1 (10.0) mg/d, respectively. Dietary intakes increased to 52.7 (45.0), 35.8 (0.00), and 64.8 (20.0) mg/d, respectively, at age 2 y (P &lt; 0.05). The predominant dietary source of EPA and DHA was fish/seafood; eggs were an important source of ARA and DHA. Dietary DHA intakes were positively associated with plasma PE and PC DHA (P &lt; 0.05). No relations between dietary ARA intakes and plasma PE and PC ARA (P &gt; 0.05) were observed. Conclusions These findings suggest that most toddlers are not meeting the recommendation for dietary PUFA intakes and that higher dietary DHA intakes are reflected in plasma PE and PC DHA composition. Further work is required to investigate a biomarker for dietary ARA intake. This trial is registered at clinicaltrials.gov as NCT01263912.

Dapagliflozin does not affect short-term blood pressure variability in patients with type-2 diabetes mellitus

2020 ◽  
Author(s):  
Eirini Papadopoulou ◽  
Marieta P Theodorakopoulou ◽  
Charalampos Loutradis ◽  
Georgios Tzanis ◽  
Glykeria Tzatzagou ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Blood Pressure Variability ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Short Term ◽  
Double Blind

Abstract Background Increased blood-pressure-variability (BPV) is associated with increased cardiovascular and all-cause mortality in patients with type 2 diabetes mellitus (T2DM). Sodium-glucose-co-transporter-2 (SGLT-2) inhibitors decrease the incidence of cardiovascular events, renal events, and death in this population. This study aimed to evaluate the effect of dapagliflozin on short-term BPV in patients with T2DM. Methods This is a secondary analysis of a double-blind, randomized, placebo-controlled trial in 85 patients with T2DM (NCT02887677). Subjects were randomized to oral dapagliflozin 10mg once daily or placebo for 12 weeks. All participants underwent 24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device at baseline and study-end. Standard-deviation (SD), weighted-SD (wSD), coefficient-of-variation (CV), average-real-variability (ARV) and variation-independent-of-mean (VIM) were calculated with validated formulae for the 24-h and the daytime and nighttime periods. Results Dapagliflozin reduced 24-h brachial BP compared to placebo. From baseline to study-end 24-h brachial BPV indexes did not change with dapagliflozin (SBP-ARV: 11.51±3.45 vs 11.05±3.35; p=0.326, SBP-wSD: 13.59±3.60 vs 13.48±3.33; p=0.811) or placebo (SBP-ARV: 11.47±3.63 vs 11.05±3.00; p=0.388, SBP-wSD: 13.85±4.38 vs 13.97±3.87 ; p=0.308). Similarly, no significant changes in BPV indexes for daytime and nighttime were observed in any group. At study-end, no differences between the groups were observed for any BPV index. Deltas(Δ) of all indexes during follow-up were minimal and not different between-groups (SBP-wSD: dapagliflozin: -0.11±3.05 vs placebo: 0.12±4.20; p=0.227). Conclusions This study is the first to evaluate the effects of an SGLT-2 inhibitor on short-term BPV in patients with T2DM, showing no effect on dapagliflozin on all BPV indexes studied.

Sign in / Sign up

Export Citation Format

Share Document