Supplementation with a β-glucan tablet has no effect on hyperlipidemia: a randomized, placebo-controlled clinical trial.

Background: Clinical evidence has suggested that the oat-soluble fiber β-glucan might have lipid-lowering effects.

Objectives: The present clinical trial was conducted to evaluate the efficacy and safety of high-medium molecular weight β-glucan on serum low-density lipoprotein (LDL) cholesterol and other lipid subfractions in subjects with hyperlipidemia.

Methods: A randomized double-blinded trial was performed to assess the efficacy and safety of β-glucan supplementation in reducing lipid levels.

Effects of common cold and concomitant administration of nasal decongestant on the pharmacokinetics and pharmacodynamics of nasal glucagon in otherwise healthy participants: A randomized clinical trial.

Aims: Nasal glucagon (NG) is a nasally-administered glucagon powder, absorbed through the nasal mucosa, designed for treatment of severe hypoglycaemia. This study evaluated the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of NG in otherwise healthy participants with common colds and after recovery from cold symptoms, with and without concomitant nasal decongestant.

Materials And Methods: This was a single-centre, open-label study.

The Oral β-Lactamase SYN-004 (Ribaxamase) Degrades Ceftriaxone Excreted into the Intestine in Phase 2a Clinical Studies.

SYN-004 (ribaxamase) is a β-lactamase designed to be orally administered concurrently with intravenous β-lactam antibiotics, including most penicillins and cephalosporins. Ribaxamase's anticipated mechanism of action is to degrade excess β-lactam antibiotic that is excreted into the small intestine. This enzymatic inactivation of excreted antibiotic is expected to protect the gut microbiome from disruption and thus prevent undesirable side effects, including secondary infections such as infections, as well as other antibiotic-associated diarrheas.

Safety, tolerability and pharmacokinetics of trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) in a randomized phase I integrated design study: single and multiple ascending doses and effect of food in healthy volunteers.

Purpose: Trimebutine 3-thiocarbamoylbenzenesulfonate (GIC-1001) is a new drug intended to be used for the management of visceral pain in patients undergoing sedation-free, full colonoscopy. The objectives of this Phase I, single-center, randomized, double-blinded, placebo-controlled, integrated study were to evaluate the safety and pharmacokinetics of GIC-1001 after single ascending doses (SAD) and multiple ascending doses (MAD) and to evaluate the influence of food on the pharmacokinetics in healthy volunteers.

Methods: GIC-1001 or placebo was orally administered to 80 healthy male and female subjects (non- or ex-smokers) aged 18 to 50 years with a body mass index between 18.

Determination of naproxen using DBS: evaluation & pharmacokinetic comparison of human plasma versus human blood DBS.

Background: Dried blood spots (DBS) sampling is a well-known technology for qualitative determination such as DNA analysis and screening of newborn metabolic disorders. The scientific community has recently expressed interest in applying the DBS technique for quantitative determination of drugs in biological fluid.

Results: Two new bioanalytical assays were developed and validated for the determination of naproxen in human plasma and in DBS samples using liquid chromatography coupled with tandem MS.

Asymmetrical growth of the photopic hill during the light adaptation effect.

In response to progressively stronger flashes delivered against a rod saturating background light, the amplitude of the photopic ERG b-wave first increases, reaches a maximal value (V (max)) and then decreases gradually to a plateau where the amplitude of the b-wave equals that of the a-wave, a phenomenon known as the photopic hill (PH). The purpose of this study was to investigate how the PH grew during the course of the light adaptation (LA) process that follows a period of dark adaptation (DA): the so-called light adaptation effect (LAE). Photopic ERG (time-integrated) luminance-response (LR) functions were obtained prior to (control-fully light adapted) and at 0, 5 and 10 min of LA following a 30-min period of DA.

Modulation of ERG retinal sensitivity parameters with light environment and photoperiod.

It has been reported that the sensitivity to light of the circadian system of animals and human subjects can be modulated following long-term exposure to a given light environment. Animal studies have also shown that long-term exposure to a light regimen, or light history, will have a significant impact on the retinal structure and function, the objective of which being to regulate the number of photons processed daily by the retina, a phenomenon referred to as photostasis. The existence of such a mechanism has never been explored in humans.

The photopic ERG of the albino guinea pig (Cavia porcellus): a model of the human photopic ERG.

Altricial rodents such as rats and mice are probably the most widely used animal model in the electroretinogram (ERG) literature. However, while the scotopic responses of these rodents share obvious similarities with that of humans, their photopic electroretinograms are strikingly different. For instance, the photopic ERGs of rats and mice include, when measurable, a minimal a-wave, while the b-wave is of much larger amplitude than that of humans.

Modulation of the human photopic ERG luminance-response function with the use of chromatic stimuli.

In response to progressively brighter flashes, the amplitude of the photopic b-wave of the human electroretinogram (ERG) first increases, then saturates at a maximal value (V(max)) to finally decrease with the brightest flashes. The purpose of this study was to investigate if this "photopic hill" could be modulated with the use of stimuli of different wavelengths. ERGs were evoked to flashes of white, blue, green and red light presented against a white background in 30 normal subjects.

Comparing the photopic ERG i-wave in different species.

The i-wave, a post b-wave component of the human photopic electroretinogram (ERG), is claimed to originate at the level of the retinal ganglion cells (RGC) or more distally. We investigated whether this wave is a feature common to all species. Photopic ERGs were obtained from the following species: Beagle dog, European cat, New Zealand white rabbit, Göttingen minipig, Cynomolgus monkey, Sprague-Dawley and brown Norway rats, Hartley guinea pig, and CD1 and C57BL6 mice.

Vigilance levels during and after bright light exposure in the first half of the night.

Fourteen healthy subjects (8 women, 6 men, aged 22-35 yr) were recruited. Each subject was exposed, in a counterbalanced order, to bright white light (BWL: 3000 lux) and to dim red light (DRL: <15 lux) at a 1-week interval. Light treatments were administered from 00:30 to 04:30 h during sleep deprivation.

The photopic ERG luminance-response function (photopic hill): method of analysis and clinical application.

With progressively brighter stimuli, the amplitude of the photopic b-wave first increases, briefly saturates and then decreases gradually to reach a plateau, where the amplitude of the b-wave equals that of the a-wave; a phenomenon previously presented as the photopic hill. The unique presentation of this luminance-response function seriously complicates its analysis with curve fitting equations such as that of Naka-Rushton used for scotopic electroretinogram. We report a method of analysis of the photopic hill based on easily identifiable and reproducible features of the ascending and descending limbs of this function.

Correlating retinal function with melatonin secretion in subjects with an early or late circadian phase.

Purpose: Evaluate the diurnal variation of retinal function, as measured with the electroretinogram (ERG), in subjects with an early (morning type: M-type) or a late (evening type: E-type) circadian phase.

Methods: Subjects (n = 24) were recruited according to their scores on a Morningness-Eveningness Questionnaire assessing preferences in, e.g.

Cone-dominated ERG luminance-response function: the Photopic Hill revisited.

Purpose: In response to progressively brighter stimuli, the b-wave of the photopic ERG gradually augments in amplitude, reaches a plateau for a narrow range of intensities and then rapidly decreases with further increments in the luminance of the flash. This unique luminance-response function was originally introduced as the Photopic Hill. The purpose of this study was to further characterize this unique feature of the cone ERG, investigate if it was only limited to b-wave measurements and if it could be obtained under different photopic background luminances.