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Effects of the Dual Endothelin Receptor Antagonist Aprocitentan on Body Weight and Fluid Homeostasis in Healthy Subjects on a High Sodium Diet.
Gueneau de Mussy, P, Sidharta, PN, Wuerzner, G, Maillard, MP, Guérard, N, Iglarz, M, Flamion, B, Dingemanse, J, Burnier, M
Clinical pharmacology and therapeutics. 2021;(3):746-753
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Abstract
Aprocitentan is a novel, oral, dual endothelin receptor antagonist (ERA) in development in difficult-to-control hypertension. As fluid retention and edema are concerns with ERAs, we investigated whether aprocitentan causes weight gain in healthy subjects on a high sodium diet and explored potential mechanisms if occurring. This double-blind, randomized, placebo-controlled, crossover study enrolled 28 subjects. Three doses of aprocitentan (10, 25, or 50 mg/day for 9 days) were compared with placebo. Increases in body weight were observed with aprocitentan (placebo-corrected mean weight gains [90% confidence interval]) of 0.43 [0.05-0.80], 0.77 [0.03-1.51], and 0.83 [0.33-1.32] kg at 10 mg, 25 mg, and 50 mg, respectively. Decreases in hemoglobin and uric acid were observed. Plasma volume increased at most by 5.5% without dose-response relationship. Urinary sodium excretion decreased at 10 mg and 25 mg but not at 50 mg. Therefore, aprocitentan produced moderate weight increases in healthy subjects on high sodium diet, without obvious sodium retention.
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Safety and Efficacy of Oral Intake of Ceramide-Containing Acetic Acid Bacteria for Improving the Stratum Corneum Hydration: A Randomized, Double-Blind, Placebo-Controlled Study over 12 Weeks.
Tsuchiya, Y, Ban, M, Kishi, M, Ono, T, Masaki, H
Journal of oleo science. 2020;(11):1497-1508
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Abstract
The barrier function of the skin protects it from external stresses to which it is constantly exposed, such as dryness, ultraviolet rays, and chemicals. Lipids, in particular a type of sphingolipid known as ceramides, play a central role in the barrier function of the skin by preventing dryness. The number of ceramides in the skin is known to decrease with age, which has led to the development of a large number of anti-aging cosmetic products that contain ceramides. Recently, it has become evident that oral intake of ceramides can also improve the quality of the skin. To elucidate the effects of oral ceramide intake on skin moisture content, we conducted a randomized, double-blinded, placebo-controlled parallel comparative study in which males and females between 20 and 60 years of age who were worried about dry skin ingested a food with acetic acid bacteria containing 0.8 mg of dihydroceramide or a placebo for 12 weeks. Concurrently, we investigated the safety of continuous ingestion of the ceramide-containing food over 12 weeks. Oral intake of ceramide over the 12 weeks significantly improved stratum corneum hydration, i.e. the moisture content of the skin, and did not result in harmful effects in any of the participants.
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Effect of Increased Daily Water Intake and Hydration on Health in Japanese Adults.
Nakamura, Y, Watanabe, H, Tanaka, A, Yasui, M, Nishihira, J, Murayama, N
Nutrients. 2020;(4)
Abstract
Increased hydration is recommended as healthy habit with several merits. However, supportive data are sparse. To assess the efficacy of increased daily water intake, we tested the effect of water supplementation on biomarkers in blood, urine, and saliva. Twenty-four healthy Japanese men and 31 healthy Japanese women with fasting blood glucose levels ranging from 90-125 mg/dL were included. An open-label, two-arm, randomized controlled trial was conducted for 12 weeks. Two additional 550 mL bottles of water on top of habitual fluid intake were consumed in the intervention group. The subjects drank one bottle of water (550 mL) within 2 h of waking, and one bottle (550 mL) 2 h before bedtime. Subjects increased mean fluid intake from 1.3 L/day to 2.0 L/day, without changes in total energy intake. Total body water rate increased with associated water supplementation. There were no significant changes in fasting blood glucose and arginine vasopressin levels, but systolic blood pressure was significantly decreased in the intervention group. Furthermore, water supplementation increased body temperature, reduced blood urea nitrogen concentration, and suppressed estimated glomerular filtration rate reduction. Additionally, existence of an intestinal microbiome correlated with decreased systolic blood pressure and increased body temperature. Habitual water supplementation after waking up and before bedtime in healthy subjects with slightly elevated fasting blood glucose levels is not effective in lowering these levels. However, it represents a safe and promising intervention with the potential for lowering blood pressure, increasing body temperature, diluting blood waste materials, and protecting kidney function. Thus, increasing daily water intake could provide several health benefits.
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Effects of isomaltulose ingestion on postexercise hydration state and heat loss responses in young men.
Amano, T, Sugiyama, Y, Okumura, J, Fujii, N, Kenny, GP, Nishiyasu, T, Inoue, Y, Kondo, N, Sasagawa, K, Enoki, Y, et al
Experimental physiology. 2019;(10):1494-1504
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Abstract
NEW FINDINGS What is the central question of this study? What are the effects of isomaltulose, an ingredient in carbohydrate-electrolyte beverages to maintain glycaemia and attenuate the risk of dehydration during exercise heat stress, on postexercise rehydration and physiological heat loss responses? What is the main finding and its importance? Consumption of a 6.5% isomaltulose-electrolyte beverage following exercise heat stress restored hydration following a 2 h recovery as compared to a 2% solution or water only. While the 6.5% isomaltulose-electrolytes increased plasma volume and plasma osmolality, which are known to modulate postexercise heat loss, sweating and cutaneous vascular responses did not differ between conditions. Consequently, ingestion beverages containing 6.5% isomaltulose-electrolytes enhanced postexercise rehydration without affecting heat loss responses. ABSTRACT Isomaltulose is a disaccharide carbohydrate widely used during exercise to maintain glycaemia and hydration. We investigated the effects of ingesting a beverage containing isomaltulose and electrolytes on postexercise hydration state and physiological heat loss responses. In a randomized, single-blind cross-over design, 10 young healthy men were hypohydrated by performing up to three 30 min successive moderate-intensity (50% heart rate reserve) bouts of cycling, each separated by 10 min, while wearing a water-perfusion suit heated to 45°C. The protocol continued until a 2% reduction in body mass was achieved. Thereafter, participants performed a final 15 min moderate-intensity exercise bout followed by a 2 h recovery. Following cessation of exercise, participants ingested a beverage consisting of (i) water only (Water), (ii) 2% isomaltulose (CHO-2%), or (iii) 6.5% isomaltulose (CHO-6.5%) equal to the volume of 2% body mass loss within the first 30 min of the recovery. Changes in plasma volume (ΔPV) after fluid ingestion were greater for CHO-6.5% compared with CHO-2% (120 min postexercise) and Water (90 and 120 min) (all P ≤ 0.040). Plasma osmolality remained elevated with CHO-6.5% compared with consumption of the other beverages at 30 and 90 min postexercise (all P ≤ 0.050). Urine output tended to be reduced with CHO-6.5% compared to other fluid conditions (main effect, P = 0.069). Rectal and mean skin temperatures, chest sweat rate and cutaneous perfusion did not differ between conditions (all P > 0.05). In conclusion, compared with CHO-2% and Water, consuming a beverage consisting of CHO-6.5% and electrolytes during recovery under heat stress enhances PV recovery without modulating physiological heat loss responses.
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Effect of tolvaptan on renal water and sodium excretion and blood pressure during nitric oxide inhibition: a dose-response study in healthy subjects.
Al Therwani, S, Rosenbæk, JB, Mose, FH, Bech, JN, Pedersen, EB
BMC nephrology. 2017;(1):86
Abstract
BACKGROUND Tolvaptan is a selective vasopressin receptor antagonist. Nitric Oxide (NO) promotes renal water and sodium excretion, but the effect is unknown in the nephron's principal cells. In a dose-response study, we measured the effect of tolvaptan on renal handling of water and sodium and systemic hemodynamics, during baseline and NO-inhibition with L-NMMA (L-NG-monomethyl-arginine). METHODS In a randomized, placebo-controlled, double blind, cross over study, 15 healthy subjects received tolvaptan 15, 30 and 45 mg or placebo. L-NMMA was given as a bolus followed by continuous infusion during 60 min. We measured urine output (UO), free water clearance (CH2O), fractional excretion of sodium (FENa), urinary aquaporin-2 channels (u-AQP2) and epithelial sodium channels (u-ENaCγ), plasma vasopressin (p-AVP) and central blood pressure (cBP). RESULTS During baseline, FENa was unchanged. Tolvaptan decreased u-ENaCγ dose-dependently and increased p-AVP threefold, whereas u-AQP2 was unchanged. During tolvaptan with NO-inhibition, UO and CH2O decreased dose-dependently. FENa decreased dose-independently and u-ENaCγ remained unchanged. Central BP increased equally after all treatments. CONCLUSIONS During baseline, fractional excretion of sodium was unchanged. During tolvaptan with NO-inhibition, renal water excretion was reduced dose dependently, and renal sodium excretion was reduced unrelated to the dose, partly via an AVP dependent mechanism. Thus, tolvaptan antagonized the reduction in renal water and sodium excretion during NO-inhibition. Most likely, the lack of decrease in AQP2 excretion by tolvaptan could be attributed to a counteracting effect of the high level of p-AVP. TRIAL REGISTRATION Clinical Trial no: NCT02078973 . Registered 1 March 2014.
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Comparative study of temporary effect on the water content at different depths of the skin by hot and cold moisturizing formulations.
Cortázar, TM, Guzmán-Alonso, M, Novoa, H, Riaño, M
Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI). 2015;(3):265-71
Abstract
BACKGROUND Researchers have studied the water content at different skin depths. Since skin differs among tissue depth, we sought to determine the depth variability of the water content after moisturizing formulation application. Furthermore, we compared the effects of formulations with different type of manufacturing processes (hot and cold process). METHODS To characterize the variations in the water content at different depths in the skin, measurements were done on the center of the inner forearm middle line of 18 sitting healthy women, before and after 1, 3, and 5 h of the application of two different moisturizing formulations (hot and cold process). Measurements included stratum corneum hydration via capacitance (SC) at 1.25 MHz (30-40 μm), and dermal water via tissue dielectric constant (TDC) at 300 MHz to depths of 500, 1500, and 2500 μm. RESULTS There were significant differences between the SC mean values at all evaluated time intervals after application of both formulations when compared to baseline before application (T0). The SC mean values at 1 and 3 h are higher than those of the 5 h post application for both formulations. When comparing the formulations, hot formulation shows higher SC levels at 3 and 5 h, than cold formulation. TDC mean values to skin depths of 500 and 1500 μm increased after the application for both formulations. This increase was statistically significant at 1 and 3 h, when compared with T0. At 5 h no increases were seen in the TDC for any of the formulations. When comparing the mean values of each time evaluated, there is no statistically significant difference between the two formulations at depth of neither 500 μm nor 1500 μm. TDC mean value to a depth of 2500 μm does not increase after the application of any of the formulations. CONCLUSIONS Hot and cold formulations are effective moisturizers; however, a distinct profile was obtained for each. When water content averages were compared, the effect of hot formulation in the superficial layers of the skin was greater and longer in time than those of the cold formulation. On the other hand, moisturizing formulations applied to the skin affected the dermis water content until depth of 1500 μm.
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Total Body Water, Electrolyte, and Thermoregulatory Responses to Ad Libitum Water Replacement Using Two Different Water Delivery Systems During a 19-km Route March.
Nolte, HW, Nolte, K, van der Meulen, J
Journal of strength and conditioning research. 2015;:S88-93
Abstract
Hands-free hydration systems are often advocated for improved hydration and performance in military populations. The aim was to assess whether such systems indeed result in improved hydration in exercising soldiers. Subjects were required to complete a route march while consuming water ad libitum from either a hydration bladder (BG) or traditional canteen (CG). Water intakes of 538 ml·h⁻¹ (BG) and 533 ml·h⁻¹ (CG) resulted in no differences for changes in body mass, serum [Na], plasma osmolality, total body water, or time required to complete the march. There were no differences between peak exercise core temperature of the BG (38.9° C) and CG (38.7° C) groups. There were no differences between the groups for fluid balance, thermoregulation, or performance. This is a not a surprising finding because the amount of fluid consumed ad libitum is determined by changes in serum osmolality and not the fluid delivery system as often proposed.
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Gender- and hydration- associated differences in the physiological response to spinning.
Ramos-Jiménez, A, Hernández-Torres, RP, Wall-Medrano, A, Torres-Durán, PV, Juárez-Oropeza, MA, Viloria, M, Villalobos-Molina, R
Nutricion hospitalaria. 2014;(3):644-51
Abstract
INTRODUCTION There is scarce and inconsistent information about gender-related differences in the hydration of sports persons, as well as about the effects of hydration on performance, especially during indoor sports. OBJECTIVE To determine the physiological differences between genders during in indoor physical exercise, with and without hydration. METHODS 21 spinning sportspeople (12 men and 9 women) participated in three controlled, randomly assigned and non-sequential hydration protocols, including no fluid intake and hydration with plain water or a sports drink (volume adjusted to each individual every 15 min), during 90 min of spinning exercise. The response variables included body mass, body temperature, heart rate and blood pressure. RESULTS During exercise without hydration, men and women lost ~2% of body mass, and showed higher body temperature (~0.2°C), blood pressure (~4 mmHg) and heart rate (~7 beats/min) compared to exercises with hydration. Body temperature and blood pressure were higher for men than for women during exercise without hydration, differences not observed during exercise with hydration. Between 42-99% of variance in body temperature, blood pressure and heart rate could be explained by the physical characteristics of subjects and the work done. CONCLUSIONS During exercise with hydration (either with water or sport drink), the physiological response was similar for both genders. Exercise without hydration produced physical stress, which could be prevented with either of the fluids (plain water was sufficient). Gender differences in the physiological response to spinning (body temperature, mean blood pressure and heart rate) can be explained in part by the distinct physical characteristics of each individual.
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The effect of hydration on the risk of friction blister formation on the heel of the foot.
Kirkham, S, Lam, S, Nester, C, Hashmi, F
Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI). 2014;(2):246-53
Abstract
BACKGROUND Friction blister research has focused on prevention and treatment approaches rather than exploring the pathophysiology of the friction blister. Increased skin hydration has been purported to be a key risk factor in friction blister development. This study aimed to test the effect of increased skin surface hydration on the risk of friction blister creation. METHODS The skin on one foot was hydrated by soaking the foot in water. Intermittent loading was carried out until an observable change of 3°C was evident using infrared thermography. The contra lateral foot acted as a control. Skin hydration and elasticity was measured using electrical capacitance and negative pressure respectively. RESULTS The rate of temperature change of the hydrated group was significantly greater than that of the non-hydrated foot group (P = 0.001) and showed a strong positive correlation (r = 0.520) with skin surface hydration. Weak negative correlations were seen between skin elasticity and rate of temperature change in response to load application (r = -0.166) and skin surface hydration and elasticity at baseline (r = -0.195). CONCLUSION In controlled experimental conditions increased skin surface hydration increases the rate of temperature change of the skin in response to load application and consequently increases the risk of blister creation.
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Effect of volume expansion with hypertonic- and isotonic saline and isotonic glucose on sodium and water transport in the principal cells in the kidney.
Jensen, JM, Mose, FH, Bech, JN, Nielsen, S, Pedersen, EB
BMC nephrology. 2013;:202
Abstract
BACKGROUND The renal distal nephron plays an important role in the maintenance of sodium balance, extra cellular volume and blood pressure. The degree of water transport, via aquaporin2 water channels (AQP2), and sodium transport, via epithelial sodium channels (ENaC) in renal collecting duct principal cells are reflected by the level of urinary excretion of AQP2 (u-AQP2) and the γ-fraction of ENaC (u-ENaCγ). The effects of an acute intravenous volume load with isotonic saline, hypertonic saline and glucose on u-AQP2, u-ENaCγ and underlying mechanisms have never been studied in a randomized, placebo-controlled trial in healthy humans. METHODS We studied the effects of 0.9% saline (23 ml/kg), 3% saline (7 ml/kg) and 5% glucose (23 ml/kg) on u-AQP2 and u-ENaCγ, fractional sodium excretion (FENa), free water clearance (CH2O), and plasma concentrations of vasopressin (AVP), renin (PRC), angiotensin II (ANG II) and aldosterone (Aldo) in a randomized, crossover study of 23 healthy subjects, who consumed a standardized diet, regarding calories, sodium and fluid for 4 days before each examination day. RESULTS After isotonic saline infusion, u-AQP2 increased (27%). CH2O and u-ENaCγ were unchanged, whereas FENa increased (123%). After hypertonic saline infusion, there was an increase in u-AQP2 (25%), u-ENaCγ (19%) and FENa (96%), whereas CH2O decreased (-153%). After isotonic glucose infusion, there was a decrease in u-AQP2 (-16%), ENaCγ (-10%) and FENa (-44%) whereas CH2O increased (164%). AVP remained unchanged after isotonic saline and glucose, but increased after hypertonic saline (139%). PRC, AngII and p-Aldo decreased after isotonic and hypertonic saline infusion, but not after glucose infusion. CONCLUSIONS Volume expansion with 3% and 0.9% saline increased u-AQP2, while isotonic glucose decreased u-AQP2. Infusion of hypertonic saline increased u-ENaCγ, whereas u-ENaCγ was not significantly changed after isotonic saline and tended to decrease after glucose. Thus, the transport of water and sodium is changed both via the aquaporin 2 water channels and the epithelial sodium channels during all three types of volume expansion to regulate and maintain water- and sodium homeostasis in the body. TRIAL REGISTRATION Clinical Trial no: NCT01414088.