Parameters In Volunteers Research Articles

Effect of a Phytochemical-Rich Olive-Derived Extract on Anthropometric, Hematological, and Metabolic Parameters.

Extra virgin olive oil is a fundamental component of the Mediterranean diet. It contains several molecules that sustain human well-being by modulating cellular metabolism and exerting antioxidant, anti-inflammatory, and anti-ageing effects to protect normal tissues, and it can exert anti-angiogenic and pro-apoptotic effects on cancer cells. Metabolites found in different parts of the olive tree, including leaves, also possess properties that might help in cancer prevention and promote wellness in aging. Olive mill wastewater (OMWW), a liquid residue produced during olive oil extraction, represents an environmental issue. However, it is rich in phytochemicals with potential beneficial properties. Dietary supplements based on OMWW can be produced for nutritional supplementation with advantages to the ecology. This work aims to measure hematochemical, anthropometric, and metabolomic parameters in volunteers taking an OMWW dietary supplement, Oliphenolia® (OMWW-OL). The supplementation of OMWW-OL 25 mL twice daily for 30 days was tested on a pilot cohort of volunteers with characteristics close to metabolic syndrome. Hematochemical, anthropometric, serum biomarkers and serum metabolomic parameters were analyzed before the intervention, at 30 days, and 30 days after stopping consumption. A total of 29 volunteers were enrolled, and 23 completed the study. The participants' parameters at baseline were measured, and then twice daily at 30 days of treatment and 30 days after assumption discontinuation. Although treatment was with an olive derivative, their weight did not increase. Their body mass index, instead of augmenting, slightly decreased, particularly in the women. Also, hydration increased, especially in the women, while blood pressure, glycemia, and insulin decreased. Cholesterol, high-density lipoproteins, and triglycerides were stable, and LDL levels decreased, while vitamin D levels, alongside calcium, perceptibly increased. Albumin also increased. All the values were in support of an equilibrium, with no damaging effects. By mass spectrometry analysis, we also found favorable changes in the vitamin D/histamine and homocysteine/methionine ratios, an increase in a new metabolite of unknown formula, and the vitamin D/unknown metabolite ratio. Supplementation of OMWW-OL has no detrimental effects and might imply the beneficial modulation of several biological parameters. Although this is a small pilot study, with limited potency, it preliminarily suggests that the OMWW extract use could be potentially valuable for people at risk of metabolic syndrome. Some of these parameters could also be relevant in supporting healthy ageing and in cancer prevention.

Short-term skin reactions and changes in stratum corneum following different ways of facial sheet mask usage

BackgroundThe global facial mask market grows steadily at 8.5% annually. However, prolonged use may lead to skin inflammation. ObjectiveTo investigate how various mask types and wearing durations impact skin physiology and aquaporins3 (AQP3) expression in healthy subjects. MethodsWe used a randomized controlled design to investigate the effects of three types of facial masks (pure water, hyaluronan, and bifida ferment lysate) and four different duration(5, 15, 25, and 40 min) on various skin parameters in volunteers, assessing moisture content, transepidermal water loss (TEWL), sebum, corneocyte size, and AQP3 expression before and after mask application, while also evaluating adverse reactions, discomfort, and noncompliance. ResultHydration and TEWL increased at first, then decreased. Sebum increased with all types of masks, particularly after 40 minutes. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71%, n=28) and dryness (57.14%, n=28), especially with pure water masks lasting over 25 minutes. ConclusionShort-term use of facial sheet masks (<25 minutes) benefits skin with improved hydration, reduced redness, and AQP3 activation, while prolonged use can lead to increased dryness and redness.

Correlations between Biochemical and Immunological Parameters in Volunteers under Conditions of 21-Day “Dry” Immersion

Correlations between Biochemical and Immunological Parameters in Volunteers under Conditions of 21-Day “Dry” Immersion

Validated LC/MS/MS Method for the Determination of Rivastigmine in Human Plasma: Application to a Pharmacokinetic Study in Egyptian Volunteers to Determine the Effect of Gender and Body Mass Index.

The effect of gender and body mass index (BMI) on the pharmacokinetics of rivastigmine was studied in Egyptian human subjects using new bio-analytical validated LC/MS/MS method. In this study, Rivastigmine was estimated in human plasma using Escitalopram as an internal standard (IS). Rivastigmine and Escitalopram were extracted from human plasma samples by liquid-liquid extraction using diethyl ether (DEE)-dichloromethane (DCM) (70:30, v/v). Chromatographic separation was performed on a reversed phase C18 INERTSIL ODS column using 0.05% aqueous formic acid, acetonitrile in the ratio (50:50, v/v) as a mobile phase. Multiple reaction monitoring (MRM) was applied and operated by positive mode electrospray ionization. A significant difference between male and female Cmax (maximum plasma concentration) (P= 0.0205; CL = 95.4) was found using Mann-Whitney U test. Also, a moderate negative correlation was found between BMI and Tmax (time to peak plasma concentration) using spearman rho test. The calculated results confirm the difference of Rivastigmine pharmacokinetics between male and female subjects. Furthermore, it indicates that Rivastigmine dose adjustment may be necessary. The method was applied for the estimation of pharmacokinetic parameters in volunteers (n= 26, 17 male and 9 female) and the effects of gender and BMI were investigated.

Smart mucoadhesive buccal chitosan/ HPMC scaffold for sore throat: In vitro, ex vivo and pharmacokinetic profiling in humans

Sore throat (ST) is exacerbated distress of throat which causes irritation during drinking and swallowing. It is conventionally treated with throat soothing lozenges or spray for symptomatic control. However, it may effectively be cured by providing sustained delivery of locally acting antiseptic and anesthetic agents for local relief. Therefore, aim of the current research was to deliver tibezonium iodide (TBN) and lignocaine hydrochloride (LGN) for the relief of sore throat as a smart mucoadhesive buccal delivery. The gel scaffolds were developed using homogenization technique and evaluated for solid-state, mucoadhesive and pharmacokinetic parameters in volunteers. Results obtained for FTIR, DSC and XRPD revealed no abnormal peak and incompatibility between ingredients in physical mixture. Sodium alginate (SA) alone or blended with chitosan (CHI) exhibited better swelling (106.1% in MG6) but did not show sustained release, mucoadhesive strength (MS) and time (FT) profile compared with CHI and hydroxyl propyl methyl cellulose HPMC based formulations. The MS and FT were improved when CHI and HPMC were combined. The desired 6 h complete in vitro release was exhibited when CHI and HPMC were formulated at a concentration of 4 and 2% w/v, respectively. It also depicted MS and FT values of 28.34 g and 249.4 min, respectively. In volunteers, the in vivo residence time (RT) was found to be 341.82 min in volunteers. The maximum salivary concentrations (Cmax) for LGN and TBN were calculated to be 40.83 and 20.2 μg/mL at 4 h (tmax), respectively. Conclusively, LGN and TBN can delivered together to release locally till 6 h as smart buccal scaffold alternative to lozenges for sore throat.

Bio-analytical methods for investigating the effect of age, body mass index and gender on the PK/PD ratio of antibiotics.

The effectiveness of antibiotics (ABs) is governed by achieving the adequate pharmacokinetic (PK)/pharmacodynamics (PD) ratio. In this study, fast LC-MS/MS methods were developed and validated for the bioanalysis of cefaclor (CFC), ciprofloxacin (CFC), roxithomycin (RXM) and clindamycin (CLD). Chromatographic separation was performed on a C18 Zorbax-Eclipse Plus (3.5 μm, 100 × 4.6 mm) using isocratic elution. Detection was performed by positive electrospray ionization. The methods were applied for the assessment of PK parameters in volunteers (n = 101, 64 male and 37 female) and the effects of age, body mass index (BMI) and gender were investigated. Good linearity (r2 ≥ 0.99), accuracy (>86%), precision (CV% ≤ 11) and extraction recovery (>83%) were observed for CFC, CFX, RXM and CLD. Application to PK studies revealed that age and BMI affected the Thalf and the AUC of RXM and CLD (p < 0.023). Gender difference affected the critical PK parameters of the four ABs (Thalf (U = 18; P = 0.036) of CFC, the Cmax of CFX (U = 30; P = 0.017), the Thalf (U = 23; P = 0.009) and AUC (U = 26; P = 0.008) of RXM and CLD), respectively. These results highlight the significance of age and BMI variations for RXM and CLD dosing. Furthermore, it indicates that the gender difference may be considered when adjusting the AB dose.

Pharmacokinetics and oxidation parameters in volunteers supplemented with microencapsulated docosahexaenoic acid

Context:Docosahexaenoic acid (DHA) is an omega-3 fatty acid essential for cardiovascular health, brain development, and reproductive function. Due to hydrophobicity and low DHA bioavailability, new microencapsulated DHA formulations are under development.Aim:This study aims to evaluate DHA pharmacokinetics (PKs) and biological oxidation parameters in volunteers ingesting a newly developed lutein-containing lycosomal formulation of DHA (LF-DHA).Materials and Methods:A total of 32 healthy volunteers (40–65 years old) with signs of oxidative stress (OS) and subclinical hypoxia were orally supplemented for a month with 250 mg of regular DHA (1st group) or a combination of lutein (7.0 mg) and zeaxanthin (1.4 mg) (2nd group). The third group received regular DHA (250 mg) co-ingested with lutein/zeaxanthin (7.0/1.4 mg), whereas the 4th group was given LF-DHA containing lutein/zeaxanthin (7.0/1.4 mg). PK, OS, and oxygenation parameters were analyzed.Results:LF-DHA improved the PKs of DHA enhancing its serum concentrations time dependently by 34.6% and 94.1% after 2nd and 4th weeks, respectively. DHA and lutein ingested either alone or simultaneously as two separate formulations reduced the levels of OS markers. However, LF-DHA inhibited the malonicdialdehyde (MDA) and oxidized low-density lipoprotein values were better than other formulations. LF-DHA also enhanced the plasma oxygen and tissue oxygen saturation. This effect was significantly higher than in other groups.Conclusion:LF-DHA eliminates the need in high-dose DHA supplementation protocols and confers a higher DHA bioavailability, thereby improving the parameters of biological oxidation and tissue respiration in affected individuals.

Estimation of contrast agent bolus arrival delays for improved reproducibility of liver DCE MRI

Delays between contrast agent (CA) arrival at the site of vascular input function (VIF) sampling and the tissue of interest affect dynamic contrast enhanced (DCE) MRI pharmacokinetic modelling. We investigate effects of altering VIF CA bolus arrival delays on liver DCE MRI perfusion parameters, propose an alternative approach to estimating delays and evaluate reproducibility.Thirteen healthy volunteers (28.7 ± 1.9 years, seven males) underwent liver DCE MRI using dual-input single compartment modelling, with reproducibility (n = 9) measured at 7 days. Effects of VIF CA bolus arrival delays were assessed for arterial and portal venous input functions. Delays were pre-estimated using linear regression, with restricted free modelling around the pre-estimated delay. Perfusion parameters and 7 days reproducibility were compared using this method, freely modelled delays and no delays using one-way ANOVA. Reproducibility was assessed using Bland–Altman analysis of agreement.Maximum percent change relative to parameters obtained using zero delays, were −31% for portal venous (PV) perfusion, +43% for total liver blood flow (TLBF), +3247% for hepatic arterial (HA) fraction, +150% for mean transit time and −10% for distribution volume. Differences were demonstrated between the 3 methods for PV perfusion (p = 0.0085) and HA fraction (p < 0.0001), but not other parameters. Improved mean differences and Bland–Altman 95% Limits-of-Agreement for reproducibility of PV perfusion (9.3 ml/min/100 g, ±506.1 ml/min/100 g) and TLBF (43.8 ml/min/100 g, ±586.7 ml/min/100 g) were demonstrated using pre-estimated delays with constrained free modelling.CA bolus arrival delays cause profound differences in liver DCE MRI quantification. Pre-estimation of delays with constrained free modelling improved 7 days reproducibility of perfusion parameters in volunteers.

Venous blood gases and cardiorespiratory parameters during aerobic exercise with different pre-exercise diet and hydration

Summary Objective To monitor and evaluate venous blood gases before and during cycle ergometer activity for one hour after three breakfast nutritional procedures offered 30 minutes before in the attempt to establish correlations between possible changes in cardiorespiratory parameters of volunteers. Methods Twelve healthy male practitioners of regular physical activity performance four sessions of continuous exercise on an cycle ergometer (60 to 70% of VO 2MaxEx ) for one hour after breakfast offered or not 30 minutes before the exercise. The sessions differed by pre-exercise meal and hydration, as follows: high glycemic index/water, low glycemic index/water, in fasting state/water and in fasting state/carbohydrate beverage (60 g/L). Statistical analysis used Analysis of Variance, Pearson correlation test, and significance level 5%. Results No significant difference was observed in the cardiorespiratory parameters of participants among the four experimental procedures, since the venous blood gases parameters showed significant differences for pH and pO 2 . The moment that showed the most significant correlations between venous blood gases and cardiorespiratory parameters was at 40 minutes of exercise. Significant negative correlation between lactate levels and base excess (BE) was observed at 20 minutes of exercise ( r = –0.31, P = 0.04).

Clinical pharmacology of exogenously administered alkaline phosphatase

To evaluate the clinical pharmacology of exogenous alkaline phosphatase (AP). Randomized, double-blind, placebo-controlled sequential protocols of (1) ascending doses and infusion duration (volunteers) and (2) fixed dose and duration (patients) were conducted at clinical pharmacology and intensive care units. A total of 103 subjects (67 male volunteers and 36 patients with severe sepsis) were administered exogenous, 10-min IV infusions (three ascending doses) or 24-72 h continuous (132.5-200 U kg(-1) 24 h(-1)) IV infusion with/without preceding loading dose and experimental endotoxemia for evaluations of pharmacokinetics, pharmacodynamics, safety parameters, antigenicity, inflammatory markers, and outcomes. Linearity and dose-proportionality were shown during 10-min infusions. The relatively short elimination half-life necessitated a loading dose to achieve stable enzyme levels. Pharmacokinetic parameters in volunteers and patients were similar. Innate immunity response was not significantly influenced by AP, while renal function significantly improved in sepsis patients. The pharmacokinetics of exogenous AP is linear, dose-proportional, exhibit a short half-life, and are not influenced by renal impairment or dialysis.

The fatty acid profiles in a drop of blood from a fingertip correlate with physiological, dietary and lifestyle parameters in volunteers

Limited data are available on the fatty acid (FA) composition of circulating lipids and the associations with diet, physiological and pathological conditions, due to the complexity and costs of the analytical process. The aim of our study was to evaluate the FA composition in 108 healthy subjects and to correlate the data with gender, pregnancy, dietary habits, lifestyle, and short-term controlled intake of n-3 FA, using an innovative analytical approach for the collection and processing of blood samples. Ten subjects were also supplemented with n-3 polyunsaturated FA as smoked salmon or capsules for 3 weeks. The resulting blood FA composition was affected by gender, pregnancy, diet and smoking. The data indicate that this new analytical methodology is suitable for assessing associations between circulating FA and various parameters in large population groups, and is applicable to epidemiological studies and in the assessment of the effects of controlled FA supplementation in clinical studies.

Dynamic magnetic resonance sialography as a new diagnostic technique for patients with Sjögren's syndrome

To evaluate the clinical utility of dynamic magnetic resonance (MR) sialographic images as a diagnostic tool for patients with Sjögren's syndrome. The morphological findings and various kinds of functional parameters in volunteers on dynamic MR sialographic images were compared with those in five patients with definite Sjögren's syndrome. On the MR sialographs of all five patients with Sjögren's syndrome, the so-called 'apple-tree appearance' was seen. The difference in two functional parameters using the dynamic MR sialographic data was elucidated between the two groups. The maximum area of the detectable ducts in the group of patients was significantly smaller (P < 0.001) than that in the group of volunteers. The ratio of change in the detectable ducts in the group of patients was significantly lower (P = 0.011) than that in the group of volunteers. Our study suggests that dynamic MR sialographic data in addition to MR sialographic images might be useful for the diagnosis of Sjögren's syndrome.

Portable pupillography of the swinging flashlight test to detect afferent pupillary defects

Objective To investigate the ability of a portable, personal computer-driven, pupillometer to record the pupillary response curve during the swinging flashlight test. Also, to determine whether these response curves can be used to identify and quantify relative asymmetry in the pupillary light reflex between eyes in healthy volunteers with simulated afferent pupil defects (APDs) and patients with optic neuropathies. Design Comparative, observational case series and instrument validation. Participants Healthy volunteers with no known ocular disease and patients (n = 20) with various optic neuropathies noted to have relative APDs on examination. Methods Pupillary response curves of the right eye were recorded with a portable, electronic, infrared pupillometer from healthy volunteers (with and without simulated APDs) and patients with APDs while the light stimulus alternated between eyes, simulating the swinging flashlight test. Simulated APDs in healthy volunteers were created with increasingly dense neutral density filters in front of the left eye. Main outcome measures Differences in constriction amplitude, latency, and constriction velocity of the pupillary response with right eye stimulation versus left eye stimulation in both groups of subjects. Results A significant correlation between neutral density filter strength and intereye differences was seen for all measurement parameters in volunteers with simulated APDs. Depending on the measurement parameter and stimulus intensity, simulated APDs of 0.6 log units or more could be distinguished from normal responses. Clinically graded true APDs had intereye differences similar to simulated APDs of the same density. Those with real and simulated APDs of 0.9 log units or more could be distinguished from healthy volunteers with 80% sensitivity and 92% specificity. Responses from those with real and simulated small APDs of 0.3 to 0.6 log units could not be distinguished reliably. Conclusions Portable, personal-computer driven, electronic, infrared pupillography can record the swinging flashlight test accurately and identify large afferent pupillary defects. An affordable, portable, reliable device for identifying relative APDs would be useful in the identification and follow-up of patients with neurogenic vision loss.