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Keywords = randomized double-blind study

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19 pages, 3326 KB  
Article
A Pilot Study of Salmon Protein Hydrolysate (ProGo®) Supplementation to Assess Its Impact on Hematologic, Integumentary and Metabolic Health
by Crawford Currie, Tor Åge Myklebust, Christian Bjerknes and Bomi Framroze
Biomedicines 2026, 14(8), 1663; https://doi.org/10.3390/biomedicines14081663 - 24 Jul 2026
Abstract
Background: Healthy ageing depends on the maintenance of several interconnected biological processes including adequate oxygen-carrying capacity, control of systemic inflammation, and preservation of lean body mass. ProGo® is a salmon protein hydrolysate (SPH) with prior evidence of benefits on iron metabolism, inflammation, [...] Read more.
Background: Healthy ageing depends on the maintenance of several interconnected biological processes including adequate oxygen-carrying capacity, control of systemic inflammation, and preservation of lean body mass. ProGo® is a salmon protein hydrolysate (SPH) with prior evidence of benefits on iron metabolism, inflammation, and metabolic health. Methods: This randomized, double-blind, active-controlled pilot study examined whether 56 days of daily ProGo® supplementation could enhance key biological drivers of healthy ageing in overweight adults, compared with an iso-nitrogenous whey protein isolate (WPI). Primary outcomes were hematological parameters and a composite integumentary (hair, nail, and skin) score, assessed with Holm–Bonferroni multiplicity adjustment. Secondary outcomes included change in body composition, inflammatory biomarkers and glucose metabolism. Results: ProGo® showed significant improvements in hemoglobin, RBC count, and ferritin, and in the integumentary composite score. Secondary analyses showed reductions in percent body fat and BMI, with preservation of lean body mass (LBM), alongside reductions in pro-inflammatory cytokines, HbA1c, and fasting blood glucose. WPI had minimal impact on any of these outcomes. Conclusions: ProGo® supplementation improved multiple key biological drivers of healthy ageing: erythropoietic function, systemic inflammation, glycemic control, and body composition. These findings are consistent with a bioactive rather than a purely nutritional effect and are hypothesis-generating with respect to a multi-domain profile relevant to healthy ageing and the maintenance of intrinsic capacity. Confirmation in larger studies is warranted. Full article
(This article belongs to the Section Molecular and Translational Medicine)
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12 pages, 970 KB  
Article
Acute Tear Secretion Response to Menthol Delivered as a Vapor to the Eye: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial
by Reinhold Vieth, Christine Griffiths and Linda M. Rapson
Pharmaceutics 2026, 18(8), 910; https://doi.org/10.3390/pharmaceutics18080910 - 24 Jul 2026
Abstract
Menthol is an agonist of TRPM8 receptors that activates tear secretion. Objectives: The hypothesis was that menthol delivered to the cornea in vapor form could stimulate tear secretion without irritation. Methods: This was a randomized, placebo-controlled, double-blind clinical trial of menthol vapor. Thirty [...] Read more.
Menthol is an agonist of TRPM8 receptors that activates tear secretion. Objectives: The hypothesis was that menthol delivered to the cornea in vapor form could stimulate tear secretion without irritation. Methods: This was a randomized, placebo-controlled, double-blind clinical trial of menthol vapor. Thirty generally healthy participants were randomized to the treatment or placebo group. Results: Median age was 58 (43, 73 IQR) years, 18 participants (60%) were female; 12 (40%) were male. Tear weight exceeded 5 mg in 2 (13.3%) of the placebo group, versus 13 (86.7%) of the menthol group (p = 0.020). Median weight of tears wiped from below the eye in the placebo group was 3 (−1, 8 IQR) mg versus 13 (8, 35 IQR) mg in the menthol group (p = 0.002). Nasolacrimal drainage in the placebo group weighed 10 (4,12 IQR) mg versus 56 (22, 173 IQR) mg in the menthol group (p < 0.001). The treated right eye felt qualitatively moister than the untreated left eye in 7 (47%) of the placebo group, versus 15 (100%) of the menthol group (p = 0.002). No participant reported eye irritation or any adverse effects at the one-week follow-up. Conclusions: Menthol delivered to the eye as vapor evoked tear secretion without eye irritation. Menthol vapor warrants further study as a complementary treatment or an alternative to eye drops for dry eye disease. Full article
(This article belongs to the Section Drug Delivery and Controlled Release)
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15 pages, 746 KB  
Systematic Review
Metabolic Effects of Testosterone Replacement Therapy in Men with Functional Secondary Hypogonadism, Obesity and Type 2 Diabetes or Metabolic Syndrome: A Systematic Review
by Christos Ntais, Apostolos Vantarakis and Ioanna P. Chatziprodromidou
Med. Sci. 2026, 14(3), 418; https://doi.org/10.3390/medsci14030418 - 22 Jul 2026
Viewed by 90
Abstract
Background/Objectives: Functional secondary hypogonadism is frequent in men with obesity, metabolic syndrome, and type 2 diabetes mellitus (T2DM), but whether testosterone replacement therapy (TRT) produces clinically relevant metabolic benefits remains uncertain. This systematic review evaluated double-blind randomized placebo-controlled trials of TRT in obese [...] Read more.
Background/Objectives: Functional secondary hypogonadism is frequent in men with obesity, metabolic syndrome, and type 2 diabetes mellitus (T2DM), but whether testosterone replacement therapy (TRT) produces clinically relevant metabolic benefits remains uncertain. This systematic review evaluated double-blind randomized placebo-controlled trials of TRT in obese men with functional secondary hypogonadism and either T2DM or metabolic syndrome. Methods: PubMed and Scopus were searched up to May 2026. Eligible studies enrolled adult men with biochemical hypogonadism and T2DM or metabolic syndrome, compared TRT with placebo, and reported metabolic outcomes. Open-label, single-blind, and non-randomized studies were excluded. Risk of bias was assessed with the Cochrane RoB 2 framework and certainty of evidence with GRADE. Results: Eight trials were included. The most consistent signal was improvement in body composition, mainly increased lean mass and reduced fat mass. Effects on insulin resistance were favorable in several trials but heterogeneous. GRADE certainty was low for fat mass, lean mass, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), and it was very low for clamp-derived insulin sensitivity, HbA1c, fasting glucose, lipid outcomes, inflammatory and vascular surrogate markers, and long-term safety. Conclusions: Low-certainty evidence suggests that TRT may improve body composition and HOMA-IR in carefully selected men with functional secondary hypogonadism and metabolic disease, whereas effects on glycemic and lipid outcomes remain very uncertain. TRT should not be regarded as an antidiabetic or lipid-lowering intervention. Larger phenotype-specific trials with longer follow-up are needed. Full article
(This article belongs to the Section Endocrinology and Metabolic Diseases)
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16 pages, 1216 KB  
Article
Effects of Acute Dietary Nitrate Supplementation on Selected Isokinetic Performance Variables in Physically Active Men
by Jakub Jurga, Jarosław Kabaciński, Anna Fryzowicz and Michał Murawa
Nutrients 2026, 18(14), 2377; https://doi.org/10.3390/nu18142377 - 21 Jul 2026
Viewed by 187
Abstract
Background: Dietary nitrate may enhance skeletal muscle performance by increasing nitric oxide bioavailability. Although its benefits for endurance exercise are well documented, less is known about its effects on isokinetic strength and power performance. This study examined the effects of acute nitrate ingestion [...] Read more.
Background: Dietary nitrate may enhance skeletal muscle performance by increasing nitric oxide bioavailability. Although its benefits for endurance exercise are well documented, less is known about its effects on isokinetic strength and power performance. This study examined the effects of acute nitrate ingestion on isokinetic performance, neuromuscular activity, and metabolic responses in physically active men. Methods: Thirteen physically active young men (25.0 ± 5.2 years) participated in a randomized, double-blind, placebo-controlled crossover study. During separate experimental sessions, participants consumed either nitrate-rich beetroot juice containing 800 mg of nitrate or a low-nitrate placebo. Following a 2 h absorption period, they performed isokinetic knee extension–flexion tests at angular velocities of 60°/s, 180°/s, and 240°/s. Surface electromyography was recorded from the vastus medialis oblique and vastus lateralis oblique muscles, and blood lactate concentrations were measured before and after exercise. Results: Nitrate supplementation significantly improved peak torque, relative peak power, and selected torque angle variables at 60°/s and 180°/s compared with placebo (p < 0.05). In contrast, no significant differences were observed during the 240°/s fatigue protocol (p > 0.05). No significant differences were observed in electromyographic parameters or post-exercise blood lactate concentration. Similarly, post-exercise blood lactate concentrations were comparable between treatments (p > 0.05). Conclusions: Acute dietary nitrate supplementation may improve selected isokinetic performance variables during low- and moderate-velocity contractions, whereas no significant effects were observed during the 240°/s fatigue protocol. No changes were detected in electromyographic parameters or post-exercise blood lactate concentration. The physiological mechanisms underlying these findings remain to be established. Full article
(This article belongs to the Special Issue The Effects of Nutritional Intake on Sports Performance)
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18 pages, 3330 KB  
Article
Short-Term Effect of a Wild Blueberry (Vaccinium angustifolium) Drink on Vascular Reactivity and Circulating Adhesion Molecules in Healthy Adults: A Double-Blind, Randomized, Placebo-Controlled, Crossover Trial
by Marco Rendine, Samuele Venturi, Mirko Marino, Daniela Martini, Patrizia Riso, Alberto Battezzati, Dorothy Klimis-Zacas and Cristian Del Bo’
Nutrients 2026, 18(14), 2376; https://doi.org/10.3390/nu18142376 - 21 Jul 2026
Viewed by 221
Abstract
Background: Wild blueberries (WB), abundant in (poly)phenols such as anthocyanins and chlorogenic acids, have shown vascular benefits in several preclinical and epidemiological settings. However, evidence from human trials remains limited. This double-blind, randomized, placebo-controlled, crossover trial investigated the effects of the consumption of [...] Read more.
Background: Wild blueberries (WB), abundant in (poly)phenols such as anthocyanins and chlorogenic acids, have shown vascular benefits in several preclinical and epidemiological settings. However, evidence from human trials remains limited. This double-blind, randomized, placebo-controlled, crossover trial investigated the effects of the consumption of a WB drink on vascular reactivity and circulating adhesion molecules in healthy young adults. Methods: Participants received 300 mL of a WB drink (30 g of freeze-dried WB powder containing 740 mg total (poly)phenols, 460 mg total anthocyanins and 170 mg chlorogenic acid) or the same amount of a placebo (PL) drink. Blood pressure, heart rate, microvascular reactivity (i.e., reactive hyperemia index, RHI, lnRHI and FRHI) and arterial stiffness (i.e., augmentation index, AIx) were assessed at baseline and 2 h after consumption of the WB and PL drinks using Endo-PAT2000. In addition, plasma circulating adhesion molecules including vascular cell adhesion molecule-1 (VCAM-1), E-selectin, and cluster of differentiation 15 (CD 15 or Lewis x) were analyzed using ELISA. Results: Overall, analysis of variance did not show a significant effect of treatment on the modulation of markers of vascular function and adhesion molecules but revealed an effect of time, with an increase in terms of microvascular reactivity (RHI, p < 0.01; lnRHI, p < 0.05; FRHI, p < 0.001) and augmentation index (AIx, p < 0.01), and a reduction in the circulating levels of VCAM-1 (p < 0.001) following the intake of both WB and PL drinks. Conclusions: In conclusion, the intake of a WB drink failed to affect vascular function in young healthy subjects. Larger-scale and longer-term intervention studies, particularly in individuals at increased cardiovascular risk and in those with vascular dysfunction, are warranted to further explore the role of WB in modulating vascular reactivity. Full article
(This article belongs to the Section Phytochemicals and Human Health)
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25 pages, 1857 KB  
Article
Cognitive and Mood Effects of a Soluble Mango Leaf Extract (Zynamite® S): A Randomized, Double-Blind, Placebo-Controlled, Crossover Replication Trial
by Ana Beltrán-Arranz, Agustín Aibar-Almazán, David Fuentes-Ríos, Rubén Pérez-Machín, María del Carmen Carcelén-Fraile, Laura López-Ríos and Yolanda Castellote-Caballero
Pharmaceuticals 2026, 19(7), 1112; https://doi.org/10.3390/ph19071112 - 18 Jul 2026
Viewed by 328
Abstract
Background/Objectives: Botanical nootropics are increasingly sought as natural alternatives to synthetic stimulants. Mangifera indica leaf extract, standardized to the polyphenol mangiferin, has shown promise in regulating brain activity and enhancing cognitive performance. This study aimed to replicate, in an independent cohort, the acute [...] Read more.
Background/Objectives: Botanical nootropics are increasingly sought as natural alternatives to synthetic stimulants. Mangifera indica leaf extract, standardized to the polyphenol mangiferin, has shown promise in regulating brain activity and enhancing cognitive performance. This study aimed to replicate, in an independent cohort, the acute cognitive benefits of a soluble mango leaf extract (Zynamite® S) following a previous proof-of-concept trial. Methods: In a double-blind, randomized, placebo-controlled crossover trial, 88 healthy young adults (aged 18–25) received either a single 100 mg dose of Zynamite® S or a matched placebo. Cognitive performance was assessed using the Trail Making Test (TMT), Digit Symbol Substitution Test (DSST), and Stroop Color-Word Test. Emotional states were assessed via the Profile of Mood States (POMS) at baseline, and then at 30 min, 3 h, and 5 h post-ingestion. Results: Zynamite® S supplementation resulted in the replication of previous findings, with significant improvements in mental processing speed, attention, and cognitive flexibility (p < 0.05). Notably, this trial identified a rapid onset of action, with significant cognitive and mood improvements detectable as early on as 30 min post-dose and a sustained duration of the effect with benefits observed up to 5 h post-administration. Mood assessments confirmed an overall improvement in emotional balance (p < 0.05) by reducing tension, mental fatigue, and low mood during the completion of cognitive-demanding tasks. Conclusions: These findings reproduce the acute benefits of Zynamite® S in a healthy young adult population, including a rapid onset of effects and a sustained improvement in cognitive performance and mood over a 5 h window. Full article
(This article belongs to the Section Natural Products)
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17 pages, 1442 KB  
Article
The Effects of Short-Term N-Acetylcysteine Supplementation on Biochemical Parameters in Endurance-Trained Adults: A Randomized Clinical Trial
by Marcin Sadowski, Emilia Zawieja, Agata Muzsik-Kazimierska, Ewa Bulczak and Agata Chmurzynska
Metabolites 2026, 16(7), 505; https://doi.org/10.3390/metabo16070505 - 18 Jul 2026
Viewed by 289
Abstract
Background: The main aim of this study was to assess the effects of short-term N-acetylcysteine (NAC) supplementation on concentrations of homocysteine (Hcy) and reduced glutathione (rGSH), blood lipid profile and liver enzyme activities in endurance-trained adults, and to determine whether these effects [...] Read more.
Background: The main aim of this study was to assess the effects of short-term N-acetylcysteine (NAC) supplementation on concentrations of homocysteine (Hcy) and reduced glutathione (rGSH), blood lipid profile and liver enzyme activities in endurance-trained adults, and to determine whether these effects are modified by methylenetetrahydrofolate reductase (MTHFR) C677T and glutathione S-transferase Pi 1 (GSTP1) A313G. Methods: A total of 56 males and 21 females completed a randomized, double-blind, placebo-controlled crossover trial. Participants received 1200 mg of NAC or a placebo for seven days in a crossover design. Serum Hcy and plasma rGSH concentrations were assessed using dedicated biochemical assays, while blood lipid profile and liver enzyme activities were measured using the biochemical analyzer Konelab 20i. Genotyping was conducted using TaqMan probes. A series of within-subject/between-subject repeated-measures analysis of variance (ANOVA) within a general linear model framework were performed to compare Hcy, rGSH, blood lipid profile and liver enzymes activities before and after the intervention. Results: Hcy concentrations significantly decreased following NAC supplementation (18.58 ± 5.45 µmol/L vs. 16.51 ± 4.97 µmol/L; p = 0.009), although subgroup analysis indicated that the decrease was significant only among females (15.40 ± 4.96 µmol/L vs. 13.60 ± 3.68 µmol/L; p = 0.002) without any significant effect among males. We did not observe any significant changes in rGSH, lipid profile, or liver enzyme activities. There was no interaction between NAC supplementation, MTHFR and GSTP1 genotypes and the changes noted in the parameters we analyzed. Conclusions: In conclusion, short-term NAC supplementation may reduce circulating Hcy concentrations in endurance-trained adults, particularly in females. No consistent effects were observed for rGSH, lipid profile, or liver enzyme activities. Full article
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13 pages, 280 KB  
Article
Effects of Short-Term (14-Day) Intake of Sucrose and Non-Caloric Sweeteners on Glucose Regulation, Blood Lipids, Gut Hormones, Inflammation Markers, and Appetite in Healthy Adults: A Randomized Controlled Trial
by Anne Nilsson
Nutrients 2026, 18(14), 2337; https://doi.org/10.3390/nu18142337 - 16 Jul 2026
Viewed by 285
Abstract
Background/Objectives: Non-caloric sweeteners are increasingly used as alternatives to sugar to reduce energy intake, yet their metabolic effects remain controversial. This study aimed to evaluate the effects of sucrose, saccharin, and steviol glycosides on glucose regulation and cardiometabolic risk markers in healthy adults. [...] Read more.
Background/Objectives: Non-caloric sweeteners are increasingly used as alternatives to sugar to reduce energy intake, yet their metabolic effects remain controversial. This study aimed to evaluate the effects of sucrose, saccharin, and steviol glycosides on glucose regulation and cardiometabolic risk markers in healthy adults. Methods: In a randomized, double-blind, crossover trial, 39 healthy, normal-weight adults consumed beverages containing sucrose (66 g/day), saccharin (220 mg/day), or steviol glycosides (220 mg/day) for 14 days, with washout periods between interventions. Metabolic outcomes were assessed at baseline and after each intervention under fasting conditions and during a 2 h postprandial test. Primary outcomes were glucose and insulin responses; secondary outcomes included gut hormones, lipids, inflammatory markers, and subjective appetite. Results: Compared with baseline, fasting glucose increased after sucrose and saccharin, and fasting insulin increased after stevia (p < 0.01). All interventions increased postprandial insulin responses and reduced indices of insulin sensitivity (p < 0.05). Fasting PYY and GLP-2 increased following all treatments (p < 0.001), without differences between sweeteners. Triglycerides were higher after sucrose than saccharin (p < 0.05), while no differences were seen for cholesterol, apolipoproteins, or CRP. Appetite ratings were unchanged, with a trend (p = 0.053) towards a reduced desire to eat after stevia in the late postprandial phase. Conclusions: Short-term intake of sucrose and non-caloric sweeteners resulted in broadly similar metabolic responses, with no significant differences in glucose regulation. However, triglyceride concentrations were higher following sucrose than saccharin, whereas no consistent differences were observed across the remaining outcomes. Observed deviations from baseline should be interpreted with caution. Further long-term studies in diverse populations are warranted. Full article
(This article belongs to the Section Carbohydrates)
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20 pages, 2074 KB  
Study Protocol
The Effect of Binaural Beats Music-Based Interventions on the Autonomic Nervous System, Considering Kinesiophobia of Reinjuries and Fitness Biomarkers in Professional Athletes with Musculoskeletal Injuries: Study Protocol for a Double-Blind Randomized Controlled Trials
by Evangelos Kontogiannis, Marianna Papadopoulou, Dimitrios Mandalidis, Apostolos Z. Skouras and Maria Papandreou
Healthcare 2026, 14(14), 2129; https://doi.org/10.3390/healthcare14142129 - 15 Jul 2026
Viewed by 333
Abstract
Background/Objectives: This study aims to evaluate the effectiveness of binaural beats (BB) on the autonomic nervous system (ANS), kinesiophobia of reinjury and fitness biomarkers in professional athletes with chronic musculoskeletal injuries. Methods: A total of 54 athletes aged 18–25 years, engaged in [...] Read more.
Background/Objectives: This study aims to evaluate the effectiveness of binaural beats (BB) on the autonomic nervous system (ANS), kinesiophobia of reinjury and fitness biomarkers in professional athletes with chronic musculoskeletal injuries. Methods: A total of 54 athletes aged 18–25 years, engaged in open-skill sports and experiencing chronic lower-limb injuries for over three months, will be recruited. They will be randomly assigned to one of three groups: an intervention group, a placebo group, and a control group. All athletes will undergo a 15 min auditory intervention five times per week for four weeks. The intervention group will listen to BB embedded in music at high beta and gamma frequencies (30–100 Hz) with guided instructions. The placebo group will receive placebo BB within the same music framework, while the control group will listen only to the music background. Assessments will be conducted at baseline, immediately post-intervention, and at a 4-week follow-up. The primary outcomes will be kinesiophobia of reinjury, ANS function, and heart rate variability (HRV), assessed using the Tampa Scale of Kinesiophobia (TSK-17), Sympathetic Skin Response (SSR), and HRV analysis, respectively. Secondary outcomes will include sport-related anxiety and pain beliefs, assessed using the Sport Competition Anxiety Test (SCAT-15) and the Pain Beliefs and Perceptions Inventory (PBPI-16), respectively; handgrip strength, assessed using the Hand Grip Test; and fitness-related biomarkers, including maximal oxygen uptake (VO2max) and blood lactate concentration. Conclusions: These findings may provide evidence supporting BB as a complementary, non-invasive intervention to enhance psychological and physiological rehabilitation in injured athletes. Ethics and Dissemination: The study has received ethical approval and is registered on ClinicalTrials.gov. Findings will be disseminated through peer-reviewed publications, conferences, and academic presentations. Full article
(This article belongs to the Special Issue Innovations in Sports Injury Prevention and Physical Rehabilitation)
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14 pages, 1077 KB  
Article
Outcomes of Single Blastocyst Transfer Versus Double Cleavage-Stage Embryo Transfer in Young Women with Recurrent Implantation Failure: A Secondary Analysis of a Multicenter Randomized Trial
by Yuan Wang, Changyang Xu, Yaqiong He, Jiaan Huang, Yun Sun, Yao Lu and Zhe Wei
J. Clin. Med. 2026, 15(14), 5544; https://doi.org/10.3390/jcm15145544 - 15 Jul 2026
Viewed by 205
Abstract
Objectives: Although blastocyst transfer may improve embryo selection and early pregnancy outcomes, its impact on live birth in women with recurrent implantation failure (RIF) remains uncertain. This study compared reproductive and perinatal outcomes between single blastocyst transfer (SBT) and double cleavage-stage embryo transfer [...] Read more.
Objectives: Although blastocyst transfer may improve embryo selection and early pregnancy outcomes, its impact on live birth in women with recurrent implantation failure (RIF) remains uncertain. This study compared reproductive and perinatal outcomes between single blastocyst transfer (SBT) and double cleavage-stage embryo transfer (DET) among women younger than 38 years with RIF. Methods: Secondary observational analysis of a multicenter, randomized, double-blind, placebo-controlled clinical trial conducted across eight academic fertility centers in China. In the original trial, patients with RIF under 38 years of age were enrolled and randomized to receive either prednisone or placebo. For the present analysis, a total of 582 patients were categorized according to the embryo transfer strategy. The SBT-versus-DET comparison was not randomized, and the two strategies differed in both embryo developmental stage and number of embryos transferred. Results: No statistically significant difference in live birth rate was observed between the SBT and DET groups (41.8% vs. 38.4%; p = 0.471), despite a higher biochemical pregnancy rate in the SBT group (59.9% vs. 45.7%, p = 0.003). Pregnancy loss was more frequent in the SBT group than in the DET group (30.2% vs. 15.9%; p = 0.018), particularly biochemical pregnancy loss (15.5% vs. 5.8%; p = 0.036), whereas twin live birth was less frequent (0.7% vs. 9.9%; p < 0.001). After adjustment, no significant difference in live birth rate was observed between DET and SBT (adjusted OR 1.04, 95% CI 0.68–1.57). In addition, Day 5 SBT showed a higher live birth rate than Day 6 SBT, whereas pregnancy loss rates were similar between Day 5 and Day 6 SBT cycles. Other exploratory sensitivity and stratified analyses showed broadly consistent findings. Conclusions: Although SBT is generally preferred in clinical practice, our study found no statistically significant difference in live birth rates between SBT and DET among women younger than 38 years with RIF. Given that pregnancy loss was observed more frequently in the SBT group, whereas twin live births were less frequent, our findings support individualized counseling rather than uniform use of either transfer strategy. However, given the non-randomized nature of this comparison, these findings should be interpreted with caution. Full article
(This article belongs to the Section Reproductive Medicine & Andrology)
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14 pages, 9752 KB  
Article
Short-Term Effect of Prismatic Lenses in Head Positioning and Kinematics in Patients with Postural Deficiency Syndrome
by João Alves da Silva, Fábio Trindade, Ivo Álvares Furtado and Pedro Fernandes
Healthcare 2026, 14(14), 2120; https://doi.org/10.3390/healthcare14142120 - 15 Jul 2026
Viewed by 264
Abstract
Background: Asymmetries in head movement are common in postural disturbances. The correction of such changes using prismatic lenses has been reported but not quantified. Methods: A controlled randomized double-blind prospective study was performed on a population with Postural Deficiency Syndrome, comparing active head [...] Read more.
Background: Asymmetries in head movement are common in postural disturbances. The correction of such changes using prismatic lenses has been reported but not quantified. Methods: A controlled randomized double-blind prospective study was performed on a population with Postural Deficiency Syndrome, comparing active head extension and rotation using prismatic and sham lenses. The evaluation was carried out using clinical photography and goniometer before intervention and 15 min after lenses’ application. Results: One hundred patients were included. The initial extension from a horizontal gaze was 53.2±12.6°, and the rotation amplitude was 113±15.2°. The overall head movement was below the standard reference values of 75° for head extension and 160° for rotation. (p<0.01 for both variables). The intervention group exhibited both an extension increase and rotation increase in amplitude: rotation improved by 8.7±9.9° (p<0.01), and extension increased on average 6.5±8.0° (p<0.01). The initial head rotation asymmetry was 10.1±4.3°, reducing to 1.70±1.58° after intervention (p<0.01). Conclusions: Patients with Postural Deficiency Syndrome have a limited and asymmetrical range of motion of head rotation and extension. These limitations are responsive to the use of low-powered prismatic lenses. Full article
(This article belongs to the Section Clinical Care)
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20 pages, 690 KB  
Article
Effects of Sativex® Versus Placebo on Glucagon-like Peptide-1, Total Ghrelin, and Subjective Appetite in Older Adults with Poor Appetite: A Protocolized Secondary Analysis of a Double-Blind, Randomized, Placebo-Controlled Crossover Trial
by Olivia Bornæs, Rikke Lundsgaard Nielsen, Louise Westberg Strejby Christensen, Ida Klitzing Storgaard, Thomas Kallemose, Helle Gybel Juul-Larsen, Juliette Tavenier, Baker Jawad, Ove Andersen, Jens Juul Holst, Bolette Hartmann, Aino Leegaard Andersen, Ingrid Poulsen, David Peick Sonne, Morten Baltzer Houlind and Mette Merete Pedersen
Nutrients 2026, 18(14), 2274; https://doi.org/10.3390/nu18142274 - 11 Jul 2026
Viewed by 227
Abstract
Background: Poor appetite, a major contributor to malnutrition, is highly prevalent among older adults and associated with adverse clinical outcomes. Nevertheless, there are currently no widely accepted or consistently effective pharmacological treatments targeting appetite that are routinely recommended alongside nutritional interventions. Medical cannabis [...] Read more.
Background: Poor appetite, a major contributor to malnutrition, is highly prevalent among older adults and associated with adverse clinical outcomes. Nevertheless, there are currently no widely accepted or consistently effective pharmacological treatments targeting appetite that are routinely recommended alongside nutritional interventions. Medical cannabis has been proposed as a potential appetite stimulant in older adults with poor appetite through modulation of appetite-regulating hormones such as glucagon-like peptide-1 (GLP-1) and total ghrelin, but the evidence remains limited. Aims: To investigate the effects of Sativex® versus placebo on postprandial GLP-1 and total ghrelin concentrations following a single dose (8.1 mg Δ9-tetrahydrocannabinol (THC) and 7.5 mg cannabidiol (CBD)), and on subjective appetite following two separated doses, in older adults with poor appetite, and to investigate the associations between plasma concentrations of THC and its metabolites on these outcomes. Methods: This protocolized secondary analysis included 17 participants (≥65 years) with poor appetite from a double-blind, randomized, placebo-controlled crossover trial. Participants received Sativex® or placebo on two separate study days. GLP-1 and total ghrelin were measured following one dose of Sativex®/placebo and a standardized breakfast, and subjective appetite was assessed repeatedly using visual analog scales throughout the administration of two separate doses of Sativex®/placebo, the consumption of a standardized breakfast, and an ad libitum lunch meal. Effects/associations were analyzed using linear mixed-effects models. Results: Compared with placebo, Sativex® produced an estimated 2.38 pmol/L (95% confidence intervals (CI): −0.71 to 5.46; Bonferroni-corrected p = 0.274) reduction in mean GLP-1 and time-dependent changes in mean total ghrelin (Bonferroni-corrected p = 0.054). Compared with placebo, Sativex® produced minimal changes in separate subjective appetite sensations (all Bonferroni-corrected p = 1.00) and a slightly lower combined appetite score (−5.2 mm; 95% CI: −24.4 to 4.0; Bonferroni-corrected p = 1.00). Increased plasma concentrations of THC and metabolites were associated with reduced estimates of mean GLP-1 concentrations and subjective appetite, as well as increased mean total ghrelin concentrations. However, no statistically significant differences were detected for any analyses, and estimates had wide CIs, warranting cautious interpretation. Conclusions: In conclusion, no statistically significant differences were detected between Sativex® and placebo in postprandial GLP-1, total ghrelin, or subjective appetite over time in older adults with poor appetite. Similarly, no statistically significant associations were observed between plasma concentrations of THC and its metabolites and GLP-1, total ghrelin, or subjective appetite. Trial registration: ClinicalTrials.gov ID: NCT05503147; EudraCT nr.: 2021-002318-15. Full article
(This article belongs to the Section Geriatric Nutrition)
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16 pages, 2740 KB  
Article
A Randomized Double-Blind Placebo-Controlled Trial of a Botanical Formulation for Symptom Management in Male Climacteric Syndrome
by Da-In Choi, Jang Hee Hong, Gyuok Lee, Jaeyong Kim and Chul-Yung Choi
Medicina 2026, 62(7), 1334; https://doi.org/10.3390/medicina62071334 - 10 Jul 2026
Viewed by 294
Abstract
Background/Objectives: Male climacteric syndrome (MCS) affects quality of life through psychological, somatic, sexual, and endocrine-related symptoms. This study evaluated whether a botanical formulation containing Elaeagnus multiflora fruit and Cynanchum wilfordii extracts (EMF_CWW) improved MCS-related symptoms compared with placebo. Methods: We conducted a 12-week, [...] Read more.
Background/Objectives: Male climacteric syndrome (MCS) affects quality of life through psychological, somatic, sexual, and endocrine-related symptoms. This study evaluated whether a botanical formulation containing Elaeagnus multiflora fruit and Cynanchum wilfordii extracts (EMF_CWW) improved MCS-related symptoms compared with placebo. Methods: We conducted a 12-week, randomized, double-blind, placebo-controlled trial (Clinical Research Information Service registration: KCT0010695) in 70 men aged 45–75 years with MCS. Participants received EMF_CWW (1500 mg/day) or placebo. The primary outcome was the change in Aging Males’ Symptoms (AMS) total score from baseline to Week 12. Secondary outcomes included AMS subdomains, Androgen Deficiency in Aging Males (ADAM) positivity, hormonal parameters, lipid profile, and safety. Efficacy analyses were conducted in the per-protocol population (n = 64), and safety analyses were conducted in the safety population (n = 70). Results: EMF_CWW did not demonstrate superiority over placebo for the primary outcome. AMS total score decreased in both groups (treatment: −14.2 ± 12.5; placebo: −15.5 ± 12.3), with no significant between-group difference (p = 0.6726). AMS subdomains and ADAM positivity also improved in both groups without significant between-group differences. Free testosterone increased non-significantly in the treatment group (+0.8 ± 2.4 pg/mL; p = 0.0727) and significantly in the placebo group (+1.3 ± 2.6 pg/mL; p = 0.0076), with no between-group difference (p = 0.8720). No treatment-related serious adverse events were observed. Conclusions: EMF_CWW did not demonstrate efficacy superior to placebo for improving MCS-related symptoms or hormonal outcomes. The improvements observed in both groups highlight placebo responsiveness, regression to the mean, and symptom variability in MCS trials. No apparent short-term safety signal was observed; however, long-term safety cannot be concluded. Larger trials with standardized repeated morning testosterone measurements are required. Full article
(This article belongs to the Section Pharmacology)
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15 pages, 1568 KB  
Article
Effect of an Ulva lactuca Extract on Systemic Antioxidant and Inflammatory Biomarkers in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
by Ralf Jäger, Hendrik Luesch, Martin Purpura, Ashok Godavarthi, Sebastian T. Balcombe and Ecaterina Vasenina
Nutrients 2026, 18(14), 2244; https://doi.org/10.3390/nu18142244 - 9 Jul 2026
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Abstract
Background: Ulva lactuca (sea lettuce) is a green macroalgae rich in sulfated polysaccharides (ulvans), polyphenols, and pigments with documented antioxidant and anti-inflammatory activity in preclinical models. Translational human data remain limited. Methods: Twenty healthy adults (20–35 years; BMI 18.5–30 kg/m2) [...] Read more.
Background: Ulva lactuca (sea lettuce) is a green macroalgae rich in sulfated polysaccharides (ulvans), polyphenols, and pigments with documented antioxidant and anti-inflammatory activity in preclinical models. Translational human data remain limited. Methods: Twenty healthy adults (20–35 years; BMI 18.5–30 kg/m2) were enrolled in a single-center, randomized, double-blind, placebo-controlled, parallel-group trial (CTRI/2025/11/097278) and assigned 1:1 to receive 300 mg of an U. lactuca extract or matched placebo once daily for 28 days. Antioxidant biomarkers (GSH, MDA, catalase, GPx-1, thioredoxin) and inflammatory biomarkers (CRP, IL-6, IL-1β, IL-11, PPAR-γ) were measured at Day 0 and Day 28. Safety was assessed throughout. Results: Eighteen of 20 participants completed the study. Compared with placebo, U. lactuca produced significant within-group improvements at Day 28 in GSH (+4.04 ng/mL), GPx-1 (+67.8 µU/mL), and catalase (+32.4 kU/L) and reductions in MDA (−6.08 nmol/mL) and thioredoxin (−1.48 ng/mL); inflammatory markers CRP (−0.91 mg/L), IL-6 (−2.97 pg/mL), IL-11 (−4.28 ± 1.88 ng/mL) and IL-1β (−8.87 pg/mL) decreased and PPAR-γ increased. Conclusions: In this short-duration pilot trial, daily supplementation with 300 mg of an U. lactuca extract was well tolerated and modulated systemic oxidative-stress and low-grade inflammatory biomarkers in healthy adults. Larger and longer studies in populations with elevated oxidative stress are warranted. Full article
(This article belongs to the Section Clinical Nutrition)
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27 pages, 4084 KB  
Article
Safety, Tolerability, and Gut Microbiota Impact of Sericin-Derived Oligopeptides (SDOs) from Yellow Silk Cocoons in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial
by Sarawut Oo-puthinan, Nanteetip Limpeanchob, Watchara Pichitsiri, Apirath Wangteeraprasert, Kanittaporn Trisat, Surangkhanang Chumee and Manote Sutheerawattananonda
Foods 2026, 15(13), 2405; https://doi.org/10.3390/foods15132405 - 7 Jul 2026
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Abstract
Sericin-derived oligopeptides (SDOs) from the Bombyx mori yellow silk cocoons show strong bioactive properties. However, clinical safety data on SDOs produced by specific enzymatic hydrolysis with a particular serine-rich (20.5%) and aspartic acid-rich (16.9%) composition is required to obtain regulatory approval as a [...] Read more.
Sericin-derived oligopeptides (SDOs) from the Bombyx mori yellow silk cocoons show strong bioactive properties. However, clinical safety data on SDOs produced by specific enzymatic hydrolysis with a particular serine-rich (20.5%) and aspartic acid-rich (16.9%) composition is required to obtain regulatory approval as a novel food ingredient. This Phase 0 randomized, double-blind, placebo-controlled trial evaluated the short-term safety, tolerability, and gut microbiota effects of SDOs supplementation in healthy adults. Forty-two healthy volunteers were randomized (1:1:1) to receive daily doses of placebo, 0.9 g SDOs or 1.8 g SDOs for eight weeks. Primary safety endpoints included vital signs, hematology, and comprehensive clinical chemistry (renal and hepatic functions). Secondary outcomes included lipid profiles, oxidative stress markers (hs-CRP, TAC, SOD, MDA) and gut microbiota composition analyzed by 16S rRNA metagenome sequencing. Forty-one participants (97.6%) completed the study with high compliance (>98%). No serious adverse events were reported. All primary clinical parameters remained within clinically normal ranges, and no significant differences between groups were observed throughout the study (p > 0.05). No adverse effects on fasting blood glucose, lipid profiles or systemic oxidative stress were observed after SDOs supplementation. Importantly, 16S rRNA sequencing analysis showed that SDOs maintained gut microbial homeostasis throughout the 8-week intervention period, with Bacteroidetes and Firmicutes as the predominant phyla in the core community structure. Oral intake of enzymatically generated SDOs up to 1.8 g/day in healthy adults was well-tolerated with only occasional mild and transient gastrointestinal symptoms that did not appear to be dose-dependent. These first preliminary findings suggest a favorable safety profile for this unique peptide preparation, supporting its potential evaluation as a novel food ingredient and providing a reasonable basis for future, larger-scale trials to evaluate its efficacy in metabolic health. Full article
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