scholarly journals Tomato Nutrient Complex Effect on Blood Pressure (P06-112-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Karin Linnewiel Hermoni ◽  
Yoav Sharoni
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Healthy Volunteers ◽  
Healthy Subjects ◽  
Controlled Study ◽  
Response Analysis ◽  
Dependent Manner ◽  
Double Blind ◽  
Dose Dependent ◽  
Different Doses

Abstract Objectives Examine the effect of a carotenoid-rich Tomato Nutrient Complex on blood pressure and perform a dose-response analysis and uncover the optimal effective supplementation dose in maintaining blood pressure within normal range among individuals with systolic blood pressure between 130–140 mmHg, otherwise healthy subjects. Methods In this double-blind, randomized, placebo-controlled study, different doses of the Tomato Nutrient Complex were examined, corresponding to 5 mg, 15 mg, and 30 mg lycopene. The effect of the tomato-derived treatment was compared with 15 mg of synthetic Lycopene and placebo over 8 weeks of treatment. In addition, we analyzed the bioavailability of the carotenoids following treatment with different doses of the Tomato Nutrient Complex in a group of 25 healthy volunteers. Volunteers were treated for four weeks with Tomato Nutrient Complex providing 2, 5 and 15 mg lycopene. Results Results indicate that treatment for 8 weeks with Tomato Nutrient Complex standardized to contain 15 mg or 30 mg of lycopene was associated with statistically significant reductions in mean SBP of 9.7 mmHg and 7 mmHg compared to baseline values respectively. Treatment with the lower dose Tomato Nutrient Complex standardized for 5 mg of lycopene, or treatment with 15 mg of synthetic lycopene as a standalone did not show a significant effect. In parallel, we analyzed the bioavailability of the carotenoids in healthy subjects. In a group of 25 healthy volunteers treated for 4 weeks with different doses of the Tomato Nutrient Complex. we identified a dose dependent and significant increase in blood level of lycopene, phytoene, and phytofluene. Conclusions Overall, the results suggest that the carotenoids in the Tomato Nutrient Complex are well absorbed in a dose dependent manner and that only the carotenoid levels achieved by the dose corresponding to 15 mg lycopene or more, is correlated to a beneficial effect on systolic blood pressure while lower doses and standalone lycopene are not enough to drive the effect. Funding Sources Lycored.

Propranolol in Experimentally Induced Stress

1981 ◽  
Vol 139 (6) ◽  
pp. 545-549 ◽  
Author(s):  
Elizabeth A. Taylor ◽  
Paul Turner ◽  
Jean Harrison
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Oral Dose ◽  
Systolic Blood Pressure ◽  
Healthy Volunteers ◽  
The Self ◽  
Experimental Stress ◽  
Double Blind ◽  
Beta Adrenoceptor ◽  
Induced Stress

SummaryThe influence of beta-adrenoceptor antagonism on the effects of a simple experimental stress was investigated in 12 healthy volunteers, using a double-blind protocol. A single oral dose of 80 mg propranolol reduced the stress-induced increase in heart rate and systolic blood pressure to 49.9 per cent and 8.3 per cent respectively compared to 61.0 per cent and 17.4 per cent with placebo. The rise in diastolic blood pressure was small and unaffected by beta-adrenoceptor blockade. The rise in temperature of the skin of the trunk was significantly reduced by propranolol. The self-rating of anxiety, alertness and concentration by the subjects was unaffected by propranolol.

scholarly journals A study of intranasally administered interferon A (rIFN-α2A) for the seasonal prophylaxis of natural viral infections of the upper respiratory tract in healthy volunteers

1988 ◽  
Vol 101 (3) ◽  
pp. 611-621 ◽  
Author(s):  
G. A Tannock ◽  
S. M Gillett ◽  
R. S Gillett ◽  
R. D Barry ◽  
M. J Hensley ◽  
...  
Keyword(s):  
Tract Infection ◽  
Respiratory Tract ◽  
Healthy Volunteers ◽  
Respiratory Tract Infection ◽  
Influenza A ◽  
Controlled Study ◽  
Response Analysis ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Upper Respiratory

SUMMARYThe efficacy of interferon A (rIFN-α2A), an Escherichia coli-derived interferon, in the prophylaxis of acute upper respiratory tract infection, was evaluated in a community-based double-blind placebo-controlled study in the Australian winter of 1985. The trial population of 412 healthy volunteers (190 males and 222 females, aged 18–65 years) self-administered 1·5, 3·0 and 6·0 megaunits (MU) of interferon A per day or a placebo, intranasally for 28 days.The period of study coincided with an outbreak of H3N2 influenza A (detected in 35 of the 107 acute specimens) as well as substantial numbers of respiratory syncytial virus and adenovirus infections. Rhinoviruses were isolated from only three specimens. In many cases, subjects had laboratory and clinical evidence of having had more than one respiratory tract infection during the period of the study. Viruses were detected in 54 or 107 acute specimens (49%).No statistically significant differences were noted between the various treatment groups in the incidence of laboratory-proven viral infection (virus isolation and/or antibody response). Analysis of reported symptoms indicated that blood-tinged mucus and nasal stuffiness occurred more frequently with higher doses of interferon. There appeared to be no clinical benefit from the use of interferon A in the amelioration of symptoms.

Abstract 13324: Single Ascending Dose Pharmacokinetics and Pharmacodynamics of MDCO-216 (ApoA-I Milano/POPC) in Healthy Volunteers

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
S. Eralp Bellibas ◽  
David Kallend ◽  
Alain Bobillier ◽  
Herman Kempen ◽  
Peter L Wijngaard
Keyword(s):  
Healthy Volunteers ◽  
Ex Vivo ◽  
Plaque Burden ◽  
Maximum Effect ◽  
Response Analysis ◽  
Cholesterol Transport ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Double Blind ◽  
First Time ◽  
Dose Dependent

Introduction: MDCO-216, a complex of dimeric recombinant apolipoprotein A-I Milano (apoA-I M) and a phospholipid (POPC), is currently under development to improve cardiovascular outcomes by reducing plaque burden in patients with atherosclerotic disease. An earlier version of MDCO-216 has been shown to reduce atherosclerotic plaque burden in animal models and in patients with ACS. The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of newly manufactured MDCO-216 first time in healthy volunteers. Methods: 24 healthy volunteers received a single dose of MDCO-216 (5, 10, 20, 30 or 40 mg/kg) or placebo (in 2:1 ratio) as a 2 hour IV infusion in a double-blind, randomised design. Serial blood samples were collected for PK and anti-drug Ab (ADA) analysis. An ex-vivo cholesterol efflux assay was used as one of several exploratory PD biomarkers for MDCO-216 activity. Results: No ADA was detected with any dose at any time point. Plasma mean T 1/2 of MDCO-216 ranged from 48 to 61 hours (56 hr. in average) and median T max ranged between 2 to 4 hours. No obvious difference in CL was observed with increases in dose and ranged from 0.62 to 0.98 mL/hr/kg. Exposure parameters increased with dose in a slightly less than dose-proportional manner with a range of 138 to 794 μg/mL for C max and 3391 to 20788 μg.hr/mL for AUC 0-48 . Dose-dependent increases in ABCA1-mediated efflux capacity of up to 4-fold above baseline and smaller increases of SRB1-mediated efflux capacity occurred rapidly after infusion at all doses. The dose-response analysis for ABCA1-mediated efflux best fitted into a sigmoid E max (maximum effect) PD model and predicts an E max of 15.6% which saturates around a 30 mg/kg dose of MDCO-216. Conclusions: This data demonstrate that MDCO-216 can profoundly stimulate the first step of reverse cholesterol transport at clinically achievable doses with a predictable PK/PD profile.

scholarly journals Dose-Dependent Effects of theCimicifuga racemosaExtract Ze 450 in the Treatment of Climacteric Complaints: A Randomized, Placebo-Controlled Study

2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Ruediger Schellenberg ◽  
Reinhard Saller ◽  
Lorenzo Hess ◽  
Jörg Melzer ◽  
Christian Zimmermann ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Symptom Relief ◽  
Hormone Treatment ◽  
Menopausal Symptoms ◽  
Controlled Study ◽  
Dependent Manner ◽  
Double Blind ◽  
The Difference ◽  
Climacteric Complaints ◽  
Dose Dependent

Extracts fromCimicifuga racemosa(CR, synonymActaea racemosa) have shown efficacy in trials in women with menopausal symptoms. Yet, dose dependency remains unclear. Therefore, 180 female outpatients with climacteric complaints were treated for 12 weeks in a randomized, double-blind, placebo-controlled, 3-armed trial (CR extract Ze 450 in 6.5 mg or 13.0 mg, or placebo). Primary outcome was the difference in menopausal symptoms (vasomotor, psychological, and somatic), assessed by the Kupperman Menopausal Index between baseline and week 12. Secondary efficacy variables were patients’ self-assessments of general quality of life (QoL), responder rates, and safety. Compared to placebo, patients receiving Ze 450 showed a significant reduction in the severity of menopausal symptoms in a dose-dependent manner from baseline to endpoint (mean absolute differences 17.0 (95% CI 14.65–19.35) score points,P<0.0001for 13.0 mg; mean absolute differences 8.47 (95% CI 5.55–11.39) score points,P=0.0003for 6.5 mg). QoL and responder rates corresponded with the main endpoint. Changes in menopausal symptoms and QoL were inversely correlated. Reported adverse events and clinical laboratory testing did not raise safety concerns. The CR extract Ze 450 is an effective and well-tolerated nonhormonal alternative to hormone treatment for symptom relief in menopausal women.

scholarly journals Safety and efficacy of ampreloxetine in symptomatic neurogenic orthostatic hypotension: a phase 2 trial

2021 ◽  
Author(s):  
Horacio Kaufmann ◽  
Ross Vickery ◽  
Whedy Wang ◽  
Jitendra Kanodia ◽  
Cyndya A. Shibao ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Orthostatic Hypotension ◽  
Controlled Study ◽  
Neurogenic Orthostatic Hypotension ◽  
Median Dose ◽  
Double Blind ◽  
Supine Blood Pressure ◽  
Part C ◽  
Standing Blood Pressure

Abstract Purpose In neurogenic orthostatic hypotension, blood pressure falls when upright owing to impaired release of norepinephrine, leading to dizziness. Ampreloxetine, a selective norepinephrine reuptake inhibitor, increases circulating norepinephrine levels. This study explored the safety of ampreloxetine and its effect on blood pressure and symptoms in patients with neurogenic orthostatic hypotension. Methods A multicenter ascending-dose trial (range 1–20 mg, Part A) was followed by a 1 day, double-blind, randomized, placebo-controlled study (median dose 15 mg, Part B). Eligible patients then enrolled in a 20-week, open-label, steady-state extension phase (median dose 10 mg, Part C) followed by a 4-week withdrawal. Assessments included the Orthostatic Hypotension Symptom Assessment Scale (item 1), supine/seated/standing blood pressure, and safety. Results Thirty-four patients (age 66 ± 8 years, 22 men) were enrolled. Part A: The proportion of participants with a positive response (i.e., increase from baseline in seated systolic blood pressure of ≥ 10 mmHg) was greater with the 5 and 10 mg ampreloxetine doses than with placebo or other active ampreloxetine doses. Part B: Seated blood pressure increased 15.7 mmHg 4 h after ampreloxetine and decreased 14.2 mmHg after placebo [least squares mean difference (95% CI) 29.9 mmHg (7.6–52.3); P = 0.0112]. Part C: Symptoms of dizziness/lightheadedness improved 3.1 ± 3.0 points from baseline and standing systolic blood pressure increased 11 ± 12 mmHg. After 4 weeks of withdrawal, symptoms returned to pretreatment levels. The effect of ampreloxetine on supine blood pressure was minimal throughout treatment duration. Conclusion Ampreloxetine was well tolerated and improved orthostatic symptoms and seated/standing blood pressure with little change in supine blood pressure. Trial registration NCT02705755 (first posted March 10, 2016).

Abstract 3218: Pharmacokinetics, Pharmacodynamics, and Safety of an Anti-von Willebrand Factor Therapeutic Aptamer, ARC1779, in Healthy Volunteers

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
James C Gilbert ◽  
Tia DeFeo-Fraulini ◽  
Renta M Hutabarat ◽  
Christopher J Horvath ◽  
Patricia G Merlino ◽  
...  
Keyword(s):  
Healthy Volunteers ◽  
Platelet Function ◽  
Therapeutic Potential ◽  
Controlled Study ◽  
Terminal Phase ◽  
Dependent Manner ◽  
Double Blind ◽  
Concentration Dependent Manner ◽  
Platelet Receptor ◽  
The Mean

Background: The prominent role played by vWF in arterial thrombogenesis suggests that vWF inhibition may offer an effective adjunct therapy to PCI in ACS patients. ARC1779 is a PEG-conjugated aptamer that blocks platelet activation through inhibition of vWF A1 domain binding to platelet receptor GPIb. Design: This was an ascending-dose, double-blind, placebo-controlled study in 47 healthy volunteers at doses of 0 (placebo, n = 6) or 0.05 to 1.0 mg/kg ARC1779 (n = 41) given via IV push, “slow bolus” IV infusion over 15 minutes, or “slow bolus” followed by 4-hour IV infusion. PK parameters were estimated from plasma ARC1779 concentrations determined with a validated assay. PD effects were measured by an ELISA for free vWF A1 binding sites and by a platelet function analyzer, the PFA-100 ® . PK: The concentration-time profiles for ARC1779 after IV push or slow bolus appeared monophasic, though the terminal phase may not have been fully captured. The C max and AUC values were dose-proportional. The highest exposure was observed after 1.0 mg/kg slow bolus, with mean C max of 21.15 μg/mL and AUC (0-∞) of 80.92 μ g·hr/mL. The mean apparent elimination half-life (t 1/2β ) was ~2 hours and mean residence time (MRT) was ~3 hours. The mean apparent volumes of distribution (V z and V ss ) were ~1/2 of the blood volume, suggesting that ARC1779 distribution is in the central compartment. The mean clearance (CL) values ranged from ~10% to 21% of GRF, suggesting that renal filtration may not be a major mechanism of clearance of ARC1779. PD: Inhibition of vWF A1 binding was achieved in a dose- and concentration-dependent manner, with respective EC 50 and EC 90 values of 0.22 μ g/mL (17 nM) and 1.98 μg/mL (151 nM). Platelet function inhibition (PFA-100 ® closure time) was achieved, with respective EC 50 and EC 90 values of 0.75 μ g/mL (57 nM) and 2.57 μg/mL (196 nM). vWF activity returned in a dose- and concentration-dependent manner. Safety: ARC1779 was generally well tolerated and no bleeding was observed. Adverse events tended to be minor and not dose related. One volunteer had a hypersensitivity reaction to IV push administration, but no such reactions occurred at higher doses given by slow bolus or infusion. Conclusion: The PK, PD and safety profile of ARC1779 supports its therapeutic potential for use in ACS.

scholarly journals Effect of hydrolysed egg protein on brain tryptophan availability

2011 ◽  
Vol 105 (4) ◽  
pp. 611-617 ◽  
Author(s):  
E. Siobhan Mitchell ◽  
Marieke Slettenaar ◽  
Frits Quadt ◽  
Timo Giesbrecht ◽  
Joris Kloek ◽  
...  
Keyword(s):  
Amino Acids ◽  
Milk Protein ◽  
Low Dose ◽  
Protein Hydrolysate ◽  
Dependent Manner ◽  
Double Blind ◽  
Egg Protein ◽  
Cognitive Benefits ◽  
Dose Dependent ◽  
Different Doses

Serotonin synthesis critically depends on plasma levels of tryptophan (TRP). Earlier studies have shown that for mood and cognitive benefits to occur, the ratio between TRP and other large neutral amino acids (LNAA) has to be increased by approximately 40 %. The present study investigated the dose-dependent effects of a TRP-rich hydrolysed protein (egg-protein hydrolysate, EPH) on the plasma TRP:LNAA. Moreover, it was investigated whether EPH could increase TRP:LNAA in the presence of 2 g of milk protein (MP). In a randomised double-blind crossover design, plasma amino acids were measured every 30 min for 3·5 h after ingestion of a drink containing either three different doses of 4, 8 and 12 g EPH containing 270, 560 or 800 mg of TRP, respectively, the combination of 4 g EPH and 2 g MP (74 mg TRP), or 4 g MP (148 mg TRP) in twenty healthy subjects with a mean age of 52 years. All three EPH doses caused significant increases of TRP:LNAA above 40 % at 30, 60 and 90 min after consumption in a dose-dependent manner. Compared with the 4 g EPH, the increase in TRP:LNAA in the 4 g EPH with 2 g MP condition was significantly lower at 60 min (63 v. 44 %, P < 0·001) and did not differ significantly at 90 min (58 v. 53 %, P>0·05). The present study showed that a low dose of 4 g EPH with even the addition of 2 g MP was sufficient to increase the ratio of TRP:LNAA above 40 %. Thus, EPH offers a viable ingredient to increase TRP availability.

scholarly journals Norepinephrine versus phenylephrine for maintenance of blood pressure during spinal anaesthesia for caesarean delivery - A randomized double blind controlled study

2021 ◽  
Vol 8 (3) ◽  
pp. 460-464
Author(s):  
Devyani Desai ◽  
Bhoomika Kalarthi
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cardiac Output ◽  
Systolic Blood Pressure ◽  
Spinal Anesthesia ◽  
Spinal Anaesthesia ◽  
Caesarean Delivery ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference

: Currently phenylephrine is a preferred 1 line vasopressor for maintenance of blood pressure during spinal anaesthesia, may be associated with reflex bradycardia and decreased cardiac output, posing risk to mother or foetus. Norepinephrine may be an useful alternative as being potent alpha with weak beta adrenergic agonist activity. : This study compared the effectiveness of prophylactic and treatment boluses of norepinephrine and phenylephrine to maintain systolic blood pressure at or above 80% of baseline value during spinal anesthesia for cesarean delivery with the primary aim to compare cardiac output. Secondary aims were total doses of study drug required, neonatal outcome and perioperative complications.: Total 100, term pregnant women with ASA status II undergoing caesarean delivery under spinal anaesthesia were enrolled in this prospective, double blind controlled study. Patients were randomized to receive prophylactic bolus dose of norepinephrine (6 µg) or phenylephrine (100 µg) immediately after spinal anaesthesia. Systolic blood pressure, cardiac output and heart rate were monitored. Intermittent bolus doses were repeated whenever required. Student ‘t’ test and chi square test were used for analysing the data. : Both the drugs were able to maintain the systolic blood pressure ≥ 80% of baseline (p=0.356). Significant difference observed in cardiac output while comparing both the groups from 3 to 15 minutes after spinal anesthesia (p=0.014). The incidence of bradycardia was lower in norepinephrine group as compared to phenylephrine group (P=0.018). : Norepinephrine is as effective as phenylephrine for maintenance of blood pressure after spinal anaesthesia for caesarean delivery with stable heart rate and cardiac output.

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