Abstract WP166: Dietary Nitrate Supplements and Ischemic Stroke Recovery: A Pilot Study

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Cheryl Bushnell ◽  
Daniel Beavers ◽  
Gary Miller ◽  
Susan Reeves ◽  
Pamela Duncan ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Placebo Group ◽  
Adverse Events ◽  
Gait Speed ◽  
Stroke Recovery ◽  
Beetroot Juice ◽  
Stroke Patients ◽  
Double Blind ◽  
Dietary Nitrate ◽  
Nitrate And Nitrite

Introduction: Dietary nitrate improves cerebral blood flow and enhances physical performance by improving exercise capacity. We designed a proof-of-concept study to show increases in plasma nitrate and nitrite levels in ischemic stroke patients treated with beetroot juice shots vs placebo juice (nitrate removed). We assessed gait speed after 30 days and safety/adverse events with both groups. Methods: In a randomized placebo-controlled double-blind design, patients with NIHSS of ≥ 2 but < 20, with fair or good sitting balance and score >0 on hip flexion on the short Fugl-Meyer, within 5 days of stroke onset were enrolled. Those treated with IV alteplase or endovascular therapy, gait speed > 0.8 cm/sec, or taking nitrate-containing medications were excluded. After consent, patients were randomized to beetroot vs placebo juice. On days 1 and 30, blood was drawn for nitrate and nitrite levels before and one hour after drinking 70 cc (3.8 mM nitrate) beetroot juice (James White Fruit Juices) or an identically-appearing placebo juice, plus vitamin C 500 mg daily for 30 days in each group. On day 30, gait speed (using the 4 m walk) was assessed. Results: Eighteen participants (6 women, 12 men, 12 white, 4 African American and 2 other race-ethnicities, median age 64.6 IQR (58.7, 70.0)) were consented, 17 completed treatment (1 terminated treatment because of nausea), 16 followed for 30 days and 13 for 90 days. Baseline characteristics were balanced with regard to admission NIHSS (median 5.0 in each group), age, sex, race, risk factors, baseline gait speed (median 0.17 m/sec in active and 0.13 m/sec in placebo), and baseline nitrate/nitrite levels. There was no difference in adverse events in the two groups. The mean treatment-specific changes in nitrate were 236 micromoles/L (95% CI 170, 302) in the active and 0 (95% CI -64, 64) in the placebo group (p<0.0001). For nitrite, active group increased by 313 nanomoles/L (37, 588) and 20 nanomoles for placebo (-211, 252); p=0.045. Gait speed increased by 0.26m/sec in the active and 0.30m/sec in placebo group. Conclusions: Beetroot juice was associated with an increase in nitrate and nitrite levels, but was not associated with a change in gait speed after 30 days. Further studies with a larger population of stroke patients may be warranted.

scholarly journals Impacts of treatments on recurrence and 28-year survival of ischemic stroke patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ting-Ann Wang ◽  
Tzy-Haw Wu ◽  
Shin-Liang Pan ◽  
Hsiu-Hsi Chen ◽  
Sherry Yueh-Hsia Chiu
Keyword(s):  
Ischemic Stroke ◽  
Cerebrovascular Disease ◽  
Cox Regression ◽  
Controlled Trial ◽  
Stroke Recurrence ◽  
Long Term Effects ◽  
Stroke Patients ◽  
Double Blind ◽  
Term Survival

AbstractAspirin and nicametate are well-established therapies for preventing recurrence and mortality from stroke in patients diagnosed as ischemic stroke. However, their respective effects on the recurrence, making allowance for the duration of recurrence and death without the occurrence of recurrence, and long-term survival have not been well elucidated. We aimed to evaluate long-term effect of two kinds of treatment on cerebrovascular death among ischemic stroke patients with or without the recurrence of stroke. Data used in this study were derived from the cohort based on a multicenter randomized double-blind controlled trial during 1992 to 1995 with the enrollment of a total of 466 patients with first-time non-cardioembolic ischemic stroke who were randomly allocated to receive aspirin (n = 222) or nicametate (n = 244). The trial cohort was followed up over time to ascertain the date of recurrence within trial period and death until Sep of 2019. The time-dependent Cox regression model was used to estimate the long-term effects of two treatments on death from cerebrovascular disease with and without recurrence. A total of 49 patients experienced stroke recurrence and 89 cerebrovascular deaths was confirmed. Patients treated with nicametate were more likely, but non statistically significantly, to have recurrence (aHR: 1.73, 95% CI 0.96–3.13) as compared with those treated by aspirin. Nicametate reduced the risk of cerebrovascular death about 37% (aHR: 0.63, 95% CI 0.41–0.97) compared with aspirin. The aspirin group had a lower recurrence rate than the nicametate group even with recurrence after 1–2 years of follow-up of first stroke but the latter had significantly reduced death from cerebrovascular disease for nicametate group, which requires more research to verify.

scholarly journals Treatment with Diazepam in Acute Stroke Prevents Poststroke Seizures: A Substudy of the EGASIS Trial

2021 ◽  
pp. 1-6
Author(s):  
Julia H. van Tuijl ◽  
Elisabeth P.M. van Raak ◽  
Robert J. van Oostenbrugge ◽  
Albert P. Aldenkamp ◽  
Rob P.W. Rouhl
Keyword(s):  
Placebo Group ◽  
Acute Stroke ◽  
Incidence Rate Ratio ◽  
Day Treatment ◽  
Stroke Patients ◽  
Early Administration ◽  
Anterior Circulation ◽  
Double Blind

<b><i>Objective:</i></b> The frequency of seizures after stroke is high, with a severe impact on the quality of life. However, little is known about their prevention. Therefore, we investigated whether early administration of diazepam prevents the development of seizures in acute stroke patients. <b><i>Methods:</i></b> We performed a substudy of the EGASIS trial, a multicenter double-blind, randomized trial in which acute stroke patients were treated with diazepam or placebo for 3 days. Follow-up was after 2 weeks and 3 months. The occurrence of seizures was registered prospectively as one of the prespecified secondary outcomes. <b><i>Results:</i></b> 784 EGASIS patients were eligible for this substudy (389 treated with diazepam [49.6%] and 395 treated with placebo [50.4%]). Seizures were reported in 19 patients (2.4% of the total patient group). Seizures occurred less frequently in patients treated with diazepam (1.5 vs. 3.3% in the placebo group); however, this difference was only statistically significant in patients with a cortical anterior circulation infarction (0.9% in the diazepam group vs. 4.6% in the placebo group, incidence rate ratio 0.20, 95% CI: 0.05–0.78, <i>p</i> = 0.02, NNT = 27). <b><i>Conclusion:</i></b> We found that a 3-day treatment with diazepam after acute cortical anterior circulation stroke prevents the occurrence of seizures in the first 3 months following stroke.

Serotonin Versus Levodopa in Ischemic Stroke Patients (SELEIS): A Randomised, Double- Blind, Placebo-Controlled Trial

2021 ◽  
Author(s):  
Dolores D. Cocho ◽  
Jordi J. Espinosa ◽  
Miguel M. Cuadrado ◽  
Carlos C. Segui ◽  
Raquel R. Cuevas ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Controlled Trial ◽  
Stroke Patients ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals The Effect of Dietary Nitrate Supplementation on Physiology and Performance in Trained Cyclists

2017 ◽  
Vol 12 (5) ◽  
pp. 684-689 ◽  
Author(s):  
Joseph A. McQuillan ◽  
Deborah K. Dulson ◽  
Paul B. Laursen ◽  
Andrew E. Kilding
Keyword(s):  
Time Trial ◽  
Crossover Design ◽  
Moderate Intensity ◽  
Beetroot Juice ◽  
Double Blind ◽  
Dietary Nitrate ◽  
Performance Time ◽  
Exercise Economy ◽  
Nitrate Supplementation ◽  
And Performance

Purpose:To determine the effect of dietary nitrate (NO3 –) supplementation on physiology and performance in well-trained cyclists after 6–8 d of NO3 – supplementation.Methods:Eight competitive male cyclists (mean ± SD age 26 ± 8 y, body mass 76.7 ± 6.9 kg, VO2peak 63 ± 4 mL · kg–1 · min–1) participated in a double-blind, placebo-controlled, crossover-design study in which participants ingested 70 mL of beetroot juice containing ~4 mmol NO3 – (NIT) or a NO3 –-depleted placebo (PLA), each for 8 d. Replicating pretreatment measures, participants undertook an incremental ramp assessment to determine VO2peak and first (VT1) and second (VT2) ventilatory thresholds on d 6 (NIT6 and PLA6), moderate-intensity cycling economy on d 7 (NIT7 and PLA7), and a 4-km time trial (TT) on d 8 (NIT8 and PLA8).Results:Relative to PLA, 6 d of NIT supplementation produced unclear effects for VO2peak (mean ± 95% confidence limit: 1.8% ± 5.5%) and VT1 (3.7% ± 12.3%) and trivial effects for both VT2 (–1.0% ± 3.0%) and exercise economy on d 7 (–1.0% ± 1.6%). However, effects for TT performance time (–0.7% ± 0.9%) and power (2.4% ± 2.5%) on d 8 were likely beneficial.Conclusions:Despite mostly unclear outcomes for standard physiological determinants of performance, 8 d of NO3 – supplementation resulted in likely beneficial improvements to 4-km TT performance in well-trained male endurance cyclists.

scholarly journals Acute beetroot juice supplementation on sympathetic nerve activity: a randomized, double-blind, placebo-controlled proof-of-concept study

2017 ◽  
Vol 313 (1) ◽  
pp. H59-H65 ◽  
Author(s):  
Karambir Notay ◽  
Anthony V. Incognito ◽  
Philip J. Millar
Keyword(s):  
Nitric Oxide ◽  
Blood Pressure ◽  
Sympathetic Outflow ◽  
Beetroot Juice ◽  
Proof Of Concept ◽  
Burst Frequency ◽  
Double Blind ◽  
Dietary Nitrate ◽  
Nitrate Supplementation ◽  
Central Sympathetic Outflow

Acute dietary nitrate ([Formula: see text]) supplementation reduces resting blood pressure in healthy normotensives. This response has been attributed to increased nitric oxide bioavailability and peripheral vasodilation, although nitric oxide also tonically inhibits central sympathetic outflow. We hypothesized that acute dietary [Formula: see text] supplementation using beetroot (BR) juice would reduce blood pressure and muscle sympathetic nerve activity (MSNA) at rest and during exercise. Fourteen participants (7 men and 7 women, age: 25 ± 10 yr) underwent blood pressure and MSNA measurements before and after (165–180 min) ingestion of 70ml high-[Formula: see text] (~6.4 mmol [Formula: see text]) BR or [Formula: see text]-depleted BR placebo (PL; ~0.0055 mmol [Formula: see text]) in a double-blind, randomized, crossover design. Blood pressure and MSNA were also collected during 2 min of static handgrip (30% maximal voluntary contraction). The changes in resting MSNA burst frequency (−3 ± 5 vs. 3 ± 4 bursts/min, P = 0.001) and burst incidence (−4 ± 7 vs. 4 ± 5 bursts/100 heart beats, P = 0.002) were lower after BR versus PL, whereas systolic blood pressure (−1 ± 5 vs. 2 ± 5 mmHg, P = 0.30) and diastolic blood pressure (4 ± 5 vs. 5 ± 7 mmHg, P = 0.68) as well as spontaneous arterial sympathetic baroreflex sensitivity ( P = 0.95) were not different. During static handgrip, the change in MSNA burst incidence (1 ± 8 vs. 8 ± 9 bursts/100 heart beats, P = 0.04) was lower after BR versus PL, whereas MSNA burst frequency (6 ± 6 vs. 11 ± 10 bursts/min, P = 0.11) as well as systolic blood pressure (11 ± 7 vs. 12 ± 8 mmHg, P = 0.94) and diastolic blood pressure (11 ± 4 vs. 11 ± 4 mmHg, P = 0.60) were not different. Collectively, these data provide proof of principle that acute BR supplementation can decrease central sympathetic outflow at rest and during exercise. Dietary [Formula: see text] supplementation may represent a novel intervention to target exaggerated sympathetic outflow in clinical populations. NEW & NOTEWORTHY The hemodynamic benefits of dietary nitrate supplementation have been attributed to nitric oxide-mediated peripheral vasodilation. Here, we provide proof of concept that acute dietary nitrate supplementation using beetroot juice can decrease muscle sympathetic outflow at rest and during exercise in a normotensive population. These results have applications for targeting central sympathetic overactivation in disease.

scholarly journals Rice Bran Supplement Containing A Functional Substance, the Novel Peptide Leu-Arg-Ala, has Anti-Hypertensive Effects: A Double-Blind, Randomized, Placebo-Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 726
Author(s):  
Ogawa ◽  
Shobako ◽  
Fukuhara ◽  
Satoh ◽  
Kobayashi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Adverse Events ◽  
Rice Bran ◽  
Test Group ◽  
Normal Blood ◽  
Controlled Study ◽  
The Novel ◽  
Normal Blood Pressure ◽  
Double Blind

The anti-hypertensive effect of processed rice bran (PRB) was recently reported, for which the novel peptide Leu-Arg-Ala (LRA) was identified as the functional substance. The purpose of this study was to assess the anti-hypertensive effects of a rice bran supplement containing PRB in individuals with high-normal blood pressure (systolic blood pressure (SBP): 130–139 mmHg and/or diastolic blood pressure (DBP): 85–89 mmHg) or grade 1 hypertension (SBP: 140–159 mmHg and/or DBP: 90–99 mmHg). One hundred individuals with high-normal blood pressure or grade 1 hypertension were recruited to participate in this double-blind, randomized, placebo-controlled study. Participants were randomly allocated to the placebo group (n = 50) or the test group (n = 50). Each group took four test tablets (43 μg LRA/day) or four placebo tablets daily. The decrease in blood pressure in the test group compared with the placebo group was the primary outcome. Adverse events were recorded and hematological/urinary parameters measured to determine the safety of the supplement, which was the secondary outcome. In total, 87 participants completed the study. The SBP of the test group at 12 weeks was significantly lower than that of the placebo group (p = 0.0497). No serious adverse events were observed. Daily consumption of a rice bran supplement containing PRB can safely improve mildly elevated blood pressure.

scholarly journals Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients—a double-blind, placebo-controlled, clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Anurag Srivastava ◽  
Manickavasagam Rengaraju ◽  
Saurabh Srivastava ◽  
Vimal Narayanan ◽  
Vivek Gupta ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Viral Load ◽  
Adverse Events ◽  
Hospital Stay ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Function Test ◽  
Stay Time ◽  
The Mean

Abstract Background and aim Globally, the ongoing pursuit in exploring an effective drug to combat severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus has not met with significant success to date. Indian traditional medicines, especially polyherbal formulations like Nilavembu Kudineer (NVK) and Kaba Sura Kudineer (KSK) of the Siddha system of medicine, have been used as public health interventions for controlling viral epidemics like dengue and Chikungunya. These traditional therapies have been found safe, effective, and widely accepted. The current study evaluates the comparative efficacy of NVK and KSK as opposed to the placebo, in the management of mild to moderate COVID-19 disease. Methods The study was a double-blind, placebo-controlled comparative clinical trial, with the primary objective of determining the efficacy of KSK and NVK. Patients (n=125) diagnosed with mild to moderate COVID-19 symptoms were enrolled in the study over a period of 4 months (Aug 2020—Dec 2020). Participants were randomized into 3 arms; placebo-decaffeinated tea in Arm I, NVK in Arm II, and KSK in Arm III. Each arm received 60 ml of the respective treatment twice a day, post morning and evening meals, along with standard allopathy treatment for a maximum of 10 days. The main outcome measures of the study were the reduction in SARS-CoV-2 viral load, hospital stay, and time taken by the patients to become asymptomatic from symptomatic. Efficacy assessments included clinical symptoms (fever, cough, and breathlessness) each day and real-time reverse transcription-polymerase chain reaction (RT-PCR), liver function test (LFT), renal function test (RFT), and electrolytes and electrocardiogram (ECG) at baseline (day 0) and days 3, 6, and 10. Post-treatment, participants were followed up for 30 days via phone for adverse effects if any. Effects of drugs on inflammatory markers (IL6) at the end of treatment were also recorded. Adverse events (AE) were monitored throughout the study. Results The results revealed that when compared to patients in the placebo arm, those in NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and the time taken to become symptomatic from asymptomatic. Out of 125 COVID-19 patients recruited, 120 completed the study; two from the placebo group developed severe symptoms and were shifted to the intensive care unit (ICU) and three patients from Arms II and III withdrew from the study. The mean age of females (n=60) and males (n=60) enrolled was between 40.2 and 44.3 years, respectively. Results were more promising for all the patients in NVK and KSK arms as all enrolled participants (100%) under this group got discharged by day 6 as compared to only 42.5% (n=17) from the placebo group on that day. The hospital stay time for patients in Arm I was significantly longer (mean [SD]=8.4 [2.0] days) as compared to the Arms II and III (mean [SD]=4.7 [1.5] and 4.2 [1.5] days, respectively (Kruskal-Wallis test, P=0.0001). Patients in the three groups took a significantly different number of days to become asymptomatic. While Arm II and III patients took mean of 2.5 and 1.7 days, respectively, Arm I, patients took a mean of 4.2 days (Kruskal-Wallis test, P=0.0001). In all, two adverse events were recorded, one for vomiting and one for diarrhea lasting a day in Arm I and Arm II, respectively. The mean value of interleukin-6 (IL6) was significantly different in comparison to the placebo-decaffeinated tea arm (NVK=2.6 and KSK=2.2, placebo=4.0, P=0.02). The other blood biochemical parameters like C-reactive protein (CRP), lactate dehydrogenase (LDH), ferritin, and D-dimer that were analyzed at the baseline and at the time of discharge from the hospital, were not significantly different in the three arms. Conclusion NVK and KSK arms showed a statistically significant reduction in hospital stay time, reduction in viral load of SARS-CoV-2, and time taken for patients to become asymptomatic from symptomatic, when compared to the placebo (decaffeinated tea). The primary outcome measures of the KSK arm were significantly better than those in the NVK arm.

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Participants, design and intervention: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. Outcome measurements and statistical analysis: The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the intervention group and 18.91 (102.27) in the placebo group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups.Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks.Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events.Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation.Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL:https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1

scholarly journals Reduction of ureteral stent encrustation by modulating the urine pH and inhibiting the crystal film with a new oral composition: a m ulticenter, placebo controlled, double blind, randomized clinical trial

2020 ◽  
Author(s):  
Carlos Torrecilla ◽  
Jaime Fernández-Concha ◽  
José R. Cansino ◽  
Juan A. Mainez ◽  
José H. Amón ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Intervention Group ◽  
Ph Control ◽  
Public Hospitals ◽  
Urine Ph ◽  
Double Blind ◽  
Double J Stent ◽  
Oral Composition

Abstract Background: Encrustation of ureteral double J stents is a common complication that may affect its removal. The aim of the proposed study is to evaluate the efficacy and safety of a new oral composition to prevent double J stent encrustation in indwelling times up to 8 weeks. Methods: A double-blinded, multicenter, placebo-controlled trial was conducted with 105 patients with indwelling double J stents enrolled across 9 public hospitals in Spain. The patients were randomly assigned (1:1) into intervention (53 patients) or placebo (52 patients) groups for 3 to 8 weeks and both groups self-monitored daily their morning urine pH levels. The primary outcome of analysis was the degree of stent ends encrustation, defined by a 4-point score (0 – none; 3 – global encrustation) using macroscopic and electron microscopy analysis of crystals, after 3 to 8-w indwelling period. Score was exponentially transformed according to calcium levels. Secondary endpoints included urine pH decrease, stent removal, and incidence of adverse events. Results: The intervention group benefits from a lower global encrustation rate of stent ends than placebo group (1% vs 8.2%; p < 0.018). Mean encrustation score was 85.12 (274.5) in the placebo group and 18.91 (102.27) in the intervention group (p < 0.025). Considering the secondary end points, treated patients reported greater urine pH decreases (p = 0.002). No differences in the incidence of adverse events were identified between the groups. Conclusions: Our data suggest that the use of this new oral composition is beneficial in the context of ureteral double J indwelling by decreasing mean, as well as global encrustation. Trial registration: This trial was registered at www.clinicaltrials.gov under the name “Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent” with date 2nd November 2017, code NCT03343275, and URL: https://clinicaltrials.gov/ct2/show/record/NCT03343275?term=NCT03343275&draw=2&rank=1 Keywords: double J stent; encrustation; nutraceutical; L-methionine; phytin; pH.

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