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Nutrients Jun 2024In the present study, we conducted a placebo-controlled, double-blind, parallel-group comparison trial in which an extract of (CM) mycelium was administered to... (Randomized Controlled Trial)
Randomized Controlled Trial
In the present study, we conducted a placebo-controlled, double-blind, parallel-group comparison trial in which an extract of (CM) mycelium was administered to long-distance runners for 16 weeks during the pre-season training period and blood test markers for anemia were investigated. The results indicated that the change rates of serum ferritin levels were moderately increased in the CM group ( = 11) but decreased in the placebo group ( = 11) during the study period, and the levels were significantly increased in the CM group compared with those in the placebo group at 4 weeks and 8 weeks after the test food intake ( < 0.05). Moreover, the change rates of hemoglobin and hematocrit were significantly increased in the CM group compared with those in the placebo group at 8 weeks after the test food intake ( < 0.05). These observations suggest that the intake of test food containing mycelium extract is expected to effectively maintain the hemoglobin and hematocrit levels in long-distance runners, possibly via the suppression of the decrease in iron storage, which is reflected by serum ferritin, during pre-season training. Furthermore, the levels of creatine kinase were increased above the normal range in both the placebo and CM groups at registration. Interestingly, the creatine kinase levels were significantly decreased in the CM group compared with those in the placebo group at 16 weeks after the test food intake ( < 0.05). These results suggest that mycelium extract exhibits a protective action on the muscle damage observed in long-distance runners and may suppress muscle injury. Together, these observations suggest that mycelium extract exhibits an improving effect on the markers for not only anemia, but also muscle injury in long-distance runners during pre-season training.
Topics: Humans; Cordyceps; Double-Blind Method; Male; Mycelium; Biomarkers; Adult; Hemoglobins; Running; Hematocrit; Ferritins; Anemia; Creatine Kinase; Athletes
PubMed: 38931190
DOI: 10.3390/nu16121835 -
Nutrients Jun 2024Ashwagandha has been reported to reduce stress and attenuate cognitive decline associated with inflammation and neurodegeneration in clinical populations. However, the... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Ashwagandha has been reported to reduce stress and attenuate cognitive decline associated with inflammation and neurodegeneration in clinical populations. However, the effects as a potential nootropic nutrient in younger populations are unclear. This study examined the effects of liposomal ashwagandha supplementation on cognitive function, mood, and markers of health and safety in healthy young men and women.
METHODS
59 men and women (22.7 ± 7 yrs., 74.9 ± 16 kg, 26.2 ± 5 BMI) fasted for 12 h, donated a fasting blood sample, and were administered the COMPASS cognitive function test battery (Word Recall, Word recognition, Choice Reaction Time Task, Picture Recognition, Digit Vigilance Task, Corsi Block test, Stroop test) and profile of mood states (POMS). In a randomized and double-blind manner, participants were administered 225 mg of a placebo (Gum Arabic) or ashwagandha () root and leaf extract coated with a liposomal covering. After 60-min, participants repeated cognitive assessments. Participants continued supplementation (225 mg/d) for 30 days and then returned to the lab to repeat the experiment. Data were analyzed using a general linear model (GLM) univariate analysis with repeated measures and pairwise comparisons of mean changes from baseline with 95% confidence intervals (CI).
RESULTS
Ashwagandha supplementation improved acute and/or 30-day measures of Word Recall (correct and recalled attempts), Choice Reaction Time (targets identified), Picture Recognition ("yes" correct responses, correct and overall reaction time), Digit Vigilance (correct reaction time), Stroop Color-Word (congruent words identified, reaction time), and POMS (tension and fatigue) from baseline more consistently with several differences observed between groups.
CONCLUSION
Results support contentions that ashwagandha supplementation (225 mg) may improve some measures of memory, attention, vigilance, attention, and executive function while decreasing perceptions of tension and fatigue in younger healthy individuals. Retrospectively registered clinical trial ISRCTN58680760.
Topics: Humans; Male; Female; Cognition; Double-Blind Method; Dietary Supplements; Young Adult; Adult; Affect; Plant Extracts; Adolescent; Reaction Time; Biomarkers; Liposomes; Plant Leaves; Plant Roots
PubMed: 38931168
DOI: 10.3390/nu16121813 -
Nutrients Jun 2024Previous studies have reported that TT genotype carriers of the adenosine A2a receptor () gene rs5751876 polymorphism have better ergogenic and anti-inflammatory... (Randomized Controlled Trial)
Randomized Controlled Trial
Previous studies have reported that TT genotype carriers of the adenosine A2a receptor () gene rs5751876 polymorphism have better ergogenic and anti-inflammatory responses to caffeine intake compared to C allele carriers. The aim of the present study was twofold: (1) to investigate the association of the rs5751876 polymorphism with acute caffeine supplementation on hormonal (growth hormone and testosterone) response to resistance exercise (RE); (2) to examine the relationship between the rs5751876 polymorphism and the resting levels of growth hormone and testosterone in athletes who are light caffeine consumers. A double-blind, crossover, placebo-controlled study involving 30 resistance-trained men (age 21.7 ± 4.1) was conducted to assess the impact of caffeine supplementation on serum growth hormone (GH) and testosterone (TS) levels before, immediately after, and 15 min post-RE. One hour before engaging in resistance exercise, subjects were randomly administered 6 mg of caffeine per kg of body mass or a placebo (maltodextrin). After a 7-day washout period, the same protocol was repeated. Resting testosterone and growth hormone levels were examined in the sera of 94 elite athletes (31 females, age 21.4 ± 2.8; 63 males, age 22.9 ± 3.8). Caffeine consumption led to significantly greater increases in GH and TS in men with the TT genotype compared to C allele carriers. Furthermore, in the group of athletes, carriers of the TT genotype had significantly higher testosterone ( = 0.0125) and growth hormone ( = 0.0365) levels compared to C allele carriers. In conclusion, the gene rs5751876 polymorphism may modify the effect of caffeine intake on the hormonal response to exercise.
Topics: Humans; Caffeine; Male; Double-Blind Method; Cross-Over Studies; Resistance Training; Receptor, Adenosine A2A; Young Adult; Testosterone; Adult; Female; Dietary Supplements; Athletes; Polymorphism, Single Nucleotide; Genotype; Human Growth Hormone; Polymorphism, Genetic; Exercise
PubMed: 38931158
DOI: 10.3390/nu16121803 -
Medicina (Kaunas, Lithuania) May 2024: Increasing evidence supporting the clinical effectiveness of cooled radiofrequency ablation (RFA) therapy for genicular nerves in patients with chronic knee... (Randomized Controlled Trial)
Randomized Controlled Trial
Effectiveness of the Cooled Radiofrequency Ablation of Genicular Nerves in Patients with Chronic Knee Pain Due to Osteoarthritis: A Double-Blind, Randomized, Controlled Study.
: Increasing evidence supporting the clinical effectiveness of cooled radiofrequency ablation (RFA) therapy for genicular nerves in patients with chronic knee osteoarthritis (OA) exists. However, no study has been conducted to eliminate the potential influence of a placebo effect associated with this procedure. Therefore, we evaluated the efficacy of cooled RFA compared with a sham procedure in patients with painful knees due to OA. : In this double-blind, randomized, controlled study, participants were randomly assigned to receive cooled RFA of the knee (cooled RFA group, n = 20) or a sham procedure (sham group, n = 20). The primary outcome was the proportion of successful responders at the three-month follow-up. The secondary outcomes were successful responders at one and six months; pain intensity of the knee; functional status; medication; and satisfaction at one, three, and six months after the procedures. : For the primary outcome, the successful responder rate was significantly higher in the cooled RFA group (76.5%) than in the sham group (33.3%) ( = 0.018). For the secondary outcome, more successful responders were observed in the cooled RFA group than in the sham group at one and six months after the procedure ( = 0.041 and 0.007, respectively). The decreased knee pain intensity was maintained throughout the six-month follow-up period in the cooled RFA group. No differences were observed in functional status, medication change, or satisfaction in both groups. : The cooled RFA of genicular nerves offers significant pain relief and surpasses the effects attributable to a placebo.
Topics: Humans; Double-Blind Method; Osteoarthritis, Knee; Female; Male; Radiofrequency Ablation; Middle Aged; Aged; Treatment Outcome; Chronic Pain; Pain Measurement; Knee Joint
PubMed: 38929474
DOI: 10.3390/medicina60060857 -
International Journal of Environmental... May 2024The intake of specific collagen peptides (SCPs) has been shown to decrease activity-related knee pain in young, physically active adults. This trial investigated the... (Randomized Controlled Trial)
Randomized Controlled Trial
The intake of specific collagen peptides (SCPs) has been shown to decrease activity-related knee pain in young, physically active adults. This trial investigated the effect of a 12-week SCP supplementation in a wider age range of healthy men and women over 18 years with functional knee and hip pain during daily activities. A total of 182 participants were randomly assigned to receive either 5 g of specific collagen peptides (CP-G) or a placebo (P-G). Pain at rest and during various daily activities were assessed at baseline and after 12 weeks by a physician and participants using a 10-point numeric rating scale (NRS). The intake of 5 g SCP over 12 weeks significantly reduced pain at rest ( = 0.018) and during walking ( = 0.032) according to the physician's evaluation. Participants in the CP-G also reported significantly less pain when climbing stairs ( = 0.040) and when kneeling down ( < 0.001) compared to the P-G. Additionally, after 12 weeks, restrictions when squatting were significantly lower in the CP-G compared with the P-G ( = 0.014). The daily intake of 5 g of SCP seems to benefit healthy adults with hip and knee joint discomforts by reducing pain during daily activities.
Topics: Humans; Male; Female; Adult; Collagen; Middle Aged; Activities of Daily Living; Young Adult; Double-Blind Method; Knee Joint; Peptides; Lower Extremity; Aged; Hip Joint; Dietary Supplements
PubMed: 38928934
DOI: 10.3390/ijerph21060687 -
BMC Veterinary Research Jun 2024The present study was performed to characterize and compare the perfusion of vaginal and uterine arteries after challenging the reproductive tract of dairy cows via...
AIM
The present study was performed to characterize and compare the perfusion of vaginal and uterine arteries after challenging the reproductive tract of dairy cows via natural mating, artificial insemination (AI), or intravaginal deposition (vaginal fundus) of different biological fluids or a placebo.
MATERIALS AND METHODS
In a double-blind study, six German Holstein cows were administered PGF during dioestrus and 48 h later treated with GnRH. Intravaginal or intrauterine treatments were carried out 12 h after GnRH was administered. Animals served as their controls, using a cross-over design with an interval of 14 days between experiments. The experimental animals were allocated to receive the following treatments: natural mating (N), intrauterine artificial insemination (A), intravaginal deposition (vaginal fundus) of 6 mL raw semen (R) or 6 mL seminal plasma (S), and compared to their controls [control 1: 6 mL placebo (P: physiological saline); control 2: no treatment (C)). Corresponding time intervals were chosen for the untreated control oestrus. Blood flow volume (BFV) in the uterine (u) and vaginal (v) arteries ipsilateral to the ovary bearing the preovulatory follicle was determined using transrectal Doppler sonography.
RESULTS
All animals exhibited oestrus and ovulated between 30 and 36 h after GnRH. Transient increases (P < 0.05) in vaginal blood flow occurred between 3 and 12 h following mating as well as 3 to 9 h after deposition of raw semen and seminal plasma, respectively. The most distinct increases (199%) in vBFV occurred 6 h after mating compared to values immediately before mating (= time 0 h). Neither AI nor deposition of a placebo into the vagina affected vBFV (P > 0.05). Only mating and deposition of either raw semen, seminal plasma or AI increased uBFV (P < 0.003). The greatest rise in uBFV occurred after natural mating. Maximum uBFV values were detected 9 h after mating when values were 79% greater (P < 0.05) than at 0 h.
CONCLUSIONS
The natural mating, deposition of raw semen or seminal plasma and conventional AI affect vaginal and/or uterine blood flow to different degrees. The factors responsible for these alterations in blood flow and their effects on fertility remain to be clarified in future studies.
Topics: Animals; Insemination, Artificial; Female; Semen; Cattle; Vagina; Uterus; Male; Administration, Intravaginal; Double-Blind Method; Gonadotropin-Releasing Hormone; Cross-Over Studies; Regional Blood Flow
PubMed: 38926710
DOI: 10.1186/s12917-024-03919-x -
Scientific Reports Jun 2024To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration,... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. Patients with neovascular age-related macular degeneration. With subfoveal, juxtafoveal, or extrafoveal choroidal neovascularization were aged 50 years or older. Intravitreal injection of SCD411 or aflibercept (2.0 mg) were administered every 4 weeks for the first three injections and every 8 weeks until week 48. The primary efficacy endpoint was the change in best-corrected visual acuity from baseline to week 8 with an adjusted equivalence margin of ± 3.0 letters. Patients were randomly assigned to receive either SCD411 (n = 288) or reference aflibercept (n = 288). A total of 566 participants (98.3%) completed week 8 of the study. The least-squares mean difference of change in best-corrected visual acuity from baseline to week 8 (SCD411-aflibercept) was - 0.4 letters (90% confidence interval = - 1.6 to 0.9). The incidence of ocular (69 of 287 [24.0%] vs. 71 of 286 [24.8%]) and serious ocular (5 of 287 [1.7%] vs. 3 of 286 [1.0%]) treatment-emergent adverse effects were similar between the SCD411 and aflibercept groups. Immunogenicity analysis revealed a low incidence of neutralizing antibody formation in both groups. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration.
Topics: Humans; Receptors, Vascular Endothelial Growth Factor; Recombinant Fusion Proteins; Male; Female; Aged; Visual Acuity; Intravitreal Injections; Treatment Outcome; Macular Degeneration; Middle Aged; Double-Blind Method; Aged, 80 and over; Choroidal Neovascularization; Biosimilar Pharmaceuticals; Angiogenesis Inhibitors
PubMed: 38926553
DOI: 10.1038/s41598-024-65815-6 -
BMJ Open Jun 2024The prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full... (Randomized Controlled Trial)
Randomized Controlled Trial
Study protocol on the efficacy of exergames-acceptance and commitment therapy program for the treatment of major depressive disorder: comparison with acceptance and commitment therapy alone and treatment-as-usual in a multicentre randomised controlled trial.
BACKGROUND
The prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full remission. However, the combination of physical exercise and psychotherapy for the treatment of MDD increase the rate of full remission among patients. This three-armed, parallel-group, double-blinded randomised controlled trial (RCT) aims to assess and compare the effects between the combination of exergame and acceptance and commitment therapy (e-ACT) programme, ACT only and treatment-as-usual (TAU) control groups on the severity of depression and anxiety symptoms, the degree of experiential avoidance and quality of life (QoL) and the serum levels of depression biomarkers (such as brain-derived neurotrophic factor, C-reactive protein and vascular endothelial growth factor) among patients with MDD across three time points.
METHODS AND ANALYSIS
This RCT will recruit 126 patients with MDD who will be randomised using stratified permuted block randomisation into three groups, which are the combined e-ACT programme, ACT-only and TAU control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT-only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the pre-intervention assessment (t), assessment immediately after completion of the intervention at 8 weeks (t) and assessment at 24 weeks after completion of the intervention (t). During each assessment, the primary outcome to be assessed includes the severity of depression symptoms, while the secondary outcomes to be assessed are the severity of anxiety symptoms, experiential avoidance, QoL and depression biomarkers.
ETHICS AND DISSEMINATION
Approval of this study was obtained from the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/PP/23050420). The findings of the study will be published in academic peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023.
Topics: Humans; Depressive Disorder, Major; Quality of Life; Acceptance and Commitment Therapy; Adult; Double-Blind Method; Male; Female; Video Games; Randomized Controlled Trials as Topic; Middle Aged; Treatment Outcome; Multicenter Studies as Topic; Exercise Therapy; Brain-Derived Neurotrophic Factor; Biomarkers
PubMed: 38926142
DOI: 10.1136/bmjopen-2023-080315 -
BMJ (Clinical Research Ed.) Jun 2024To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3).
DESIGN
Multicentre, double blind, randomised, placebo controlled trial.
SETTING
244 hospitals in China between 11 August 2022 and 13 April 2023.
PARTICIPANTS
8343 patients aged 40 years of age or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L were enrolled.
INTERVENTIONS
Patients were randomly assigned 1:1 within 24 h of symptom onset to receive colchicine (0.5 mg twice daily on days 1-3, followed by 0.5 mg daily thereafter) or placebo for 90 days.
MAIN OUTCOME MEASURES
The primary efficacy outcome was any new stroke within 90 days after randomisation. The primary safety outcome was any serious adverse event during the treatment period. All efficacy and safety analyses were by intention to treat.
RESULTS
4176 patients were assigned to the colchicine group and 4167 were assigned to the placebo group. Stroke occurred within 90 days in 264 patients (6.3%) in the colchicine group and 270 patients (6.5%) in the placebo group (hazard ratio 0.98 (95% confidence interval 0.83 to 1.16); P=0.79). Any serious adverse event was observed in 91 (2.2%) patients in the colchicine group and 88 (2.1%) in the placebo group (P=0.83).
CONCLUSIONS
The study did not provide evidence that low-dose colchicine could reduce the risk of subsequent stroke within 90 days as compared with placebo among patients with acute non-cardioembolic minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT05439356.
Topics: Humans; Colchicine; Male; Female; Double-Blind Method; Middle Aged; Ischemic Attack, Transient; Aged; Ischemic Stroke; Treatment Outcome; China; C-Reactive Protein; Adult
PubMed: 38925803
DOI: 10.1136/bmj-2023-079061 -
BMJ Open Jun 2024Acute-on-chronic liver failure (ACLF) is a prevalent and life-threatening liver disease with high short-term mortality. Although recent clinical trials on the use of...
Human umbilical cord mesenchymal stem cell transplantation for the treatment of acute-on-chronic liver failure: protocol for a multicentre random double-blind placebo-controlled trial.
INTRODUCTION
Acute-on-chronic liver failure (ACLF) is a prevalent and life-threatening liver disease with high short-term mortality. Although recent clinical trials on the use of mesenchymal stem cells (MSCs) for ACLF treatment have shown promising results, multicentre randomised controlled phase II clinical trials remain uncommon. The primary aim of this trial is to assess the safety and efficacy of different MSCs treatment courses for ACLF.
METHODS AND ANALYSIS
This is a multicentre, double-blind, two-stage, randomised and placebo-controlled clinical trial. In the first stage, 150 patients with ACLF will be enrolled and randomly assigned to either a control group (50 cases) or an MSCs treatment group (100 cases). They will receive either a placebo or umbilical cord-derived MSCs (UC-MSCs) treatment three times (at weeks 0, 1 and 2). In the second stage, 28 days after the first UC-MSCs infusion, surviving patients in the MSCs treatment group will be further randomly divided into MSCs-short and MSCs-prolonged groups at a 1:1 ratio. They will receive two additional rounds of placebo or UC-MSCs treatment at weeks 4 and 5. The primary endpoints are the transplant-free survival rate and the incidence of treatment-related adverse events. Secondary endpoints include international normalised ratio, total bilirubin, serum albumin, blood urea nitrogen, model for end-stage liver disease score and Child-Turcotte-Pugh score.
ETHICS AND DISSEMINATION
Ethical approval of this study has been obtained from the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-3-19-1). All results of the study will be submitted to international journals and international conferences for publication on completion of the study.
TRIAL REGISTRATION NUMBER
NCT05985863.
Topics: Humans; Acute-On-Chronic Liver Failure; Double-Blind Method; Mesenchymal Stem Cell Transplantation; Umbilical Cord; Adult; Female; Male; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Middle Aged; Treatment Outcome
PubMed: 38925694
DOI: 10.1136/bmjopen-2024-084237