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Nutrients Jun 2024Guarana (GUA), a Brazilian seed extract, contains caffeine and other bioactive compounds that may have psychoactive effects. To assess the acute effects of GUA compared... (Randomized Controlled Trial)
Randomized Controlled Trial
Guarana (GUA), a Brazilian seed extract, contains caffeine and other bioactive compounds that may have psychoactive effects. To assess the acute effects of GUA compared to a low dose of caffeine (CAF) on cognitive and mood parameters, twenty participants completed a double-blind, crossover experiment where they ingested capsules containing the following: (1) 100 mg CAF, (2) 500 mg GUA containing 130 mg caffeine, or (3) placebo (PLA). Cognitive tests (Simon and 2N-Back Task) were performed at the baseline (pre-ingestion) and 60 min after ingestion. The response time for the cognitive tests and heart rate variability were unaffected ( > 0.05) by treatment, although 2N-Back was overall faster ( = 0.001) across time. The accuracy in the 2N-Back Task showed a significant interaction effect ( = 0.029) due to higher post-ingestion versus pre-ingestion levels ( = 0.033), but only with the PLA. The supplements also had no effect on cognitive measures following physical fatigue ( = 11). There was an interaction effect on perceived mental energy, where the pre-ingestion of GUA had lower mental pep ratings compared to post-ingestion ( = 0.006) and post-exercise ( = 0.018) levels. Neither the acute ingestion of GUA nor low dose of CAF influenced cognitive performance or provided consistent benefit on mood or mental workload through vagal modulation. Additional investigations are beneficial to determining the lowest effective dose for CAF or GUA to influence mood and/or cognitive performance.
Topics: Humans; Caffeine; Paullinia; Male; Cross-Over Studies; Double-Blind Method; Cognition; Adult; Young Adult; Female; Heart Rate; Affect; Vagus Nerve; Plant Extracts; Dietary Supplements
PubMed: 38931247
DOI: 10.3390/nu16121892 -
Nutrients Jun 2024Brown seaweed is promising for the treatment of type 2 diabetes mellitus (T2DM). Its bioactive constituents can positively affect plasma glucose homeostasis in healthy... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Brown seaweed is promising for the treatment of type 2 diabetes mellitus (T2DM). Its bioactive constituents can positively affect plasma glucose homeostasis in healthy humans. We investigated the effect of the brown seaweeds and in their natural form on glucose regulation in patients with T2DM.
METHODS
We conducted a randomized, double-blind, placebo-controlled pilot trial. Thirty-six participants with T2DM received, on a daily basis, either 5 g of dried , 5 g of dried , or 0.5 g of dried (control) for 5 weeks, alongside regular treatment. The primary outcome was the between-group difference in the change in weekly average blood glucose levels (continuous glucose monitoring). The secondary outcomes were the changes in anthropometrics, plasma lipid levels, and dietary intake. The data were analyzed using a linear mixed-effects model.
RESULTS
The change in weekly average glucose levels was 8.2 ± 2.1 to 9.0 ± 0.7 mmol/L ( = 0.2) in the group (n = 12) and 10.1 ± 3.3 to 9.2 ± 0.7 mmol/L ( = 0.9) in the group (n = 10). The between-group difference was non-significant. Similarly, no between-group differences were observed for the changes in the secondary outcomes.
DISCUSSION
A daily intake of 5 g of fresh, dried or alongside regular treatment had no differential effect on weekly average blood glucose levels in T2DM.
Topics: Humans; Diabetes Mellitus, Type 2; Sargassum; Double-Blind Method; Blood Glucose; Male; Female; Middle Aged; Fucus; Pilot Projects; Overweight; Feasibility Studies; Aged; Adult; Seaweed; Hypoglycemic Agents; Edible Seaweeds
PubMed: 38931192
DOI: 10.3390/nu16121837 -
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 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 -
Journal of Clinical Medicine Jun 2024In observational studies, high levels of desphospho-uncarboxylated matrix gla protein (dp-ucMGP) that result from vitamin K deficiency were consistently associated with...
In observational studies, high levels of desphospho-uncarboxylated matrix gla protein (dp-ucMGP) that result from vitamin K deficiency were consistently associated with poor clinical outcomes during COVID-19. Vitamin K-activated matrix gla protein (MGP) is required to protect against elastic fibre degradation, and a deficiency may contribute to pathology. However, intervention trials assessing the effects of vitamin K supplementation in COVID-19 are lacking. This is a single-centre, phase 2, double-blind, randomised, placebo-controlled trial investigating the effects of vitamin K2 supplementation in 40 hospitalised COVID-19 patients requiring supplemental oxygen. Individuals were randomly assigned in a 1:1 ratio to receive 999 mcg of vitamin K2-menaquinone-7 (MK-7)-or a placebo daily until discharge or for a maximum of 14 days. Dp-ucMGP, the rate of elastic fibre degradation quantified by desmosine, and hepatic vitamin K status quantified by PIVKA-II were measured. Grade 3 and 4 adverse events were collected daily. As an exploratory objective, circulating vitamin K2 levels were measured. Vitamin K2 was well tolerated and did not increase the number of adverse events. A linear mixed model analysis showed that dp-ucMGP and PIVKA-II decreased significantly in subjects that received supplementation compared to the controls ( = 0.008 and = 0.0017, respectively), reflecting improved vitamin K status. The decrease in dp-ucMGP correlated with higher plasma MK-7 levels ( = 0.015). No significant effect on desmosine was found ( = 0.545). These results demonstrate that vitamin K2 supplementation during COVID-19 is safe and decreases dp-ucMGP. However, the current dose of vitamin K2 failed to show a protective effect against elastic fibre degradation.
PubMed: 38930004
DOI: 10.3390/jcm13123476 -
Journal of Clinical Medicine Jun 2024Migraine is one of the most common diseases in highly developed countries, being even more common than diabetes and asthma. Migraines can affect emotional, social, and...
Migraine is one of the most common diseases in highly developed countries, being even more common than diabetes and asthma. Migraines can affect emotional, social, and physical wellbeing as well as professional life. The most common symptoms are severe headaches associated with nausea, vomiting, photophobia and sonophobia, difficulty concentrating, sensitivity and emotional disorders. Many studies have been published to establish the best migraine-management drugs, but not many of them refer to plant extracts, which have been given more attention by patients lately. Among these generically called herbal medicines, the effect of tussilago hybrida standardized extract has been studied since the early twenties. This stands as the fundamental component of Neurasites and the reason for research on materials and methods, results on treatment schemes for diminishing migraine attack features, as well as migraine prevention. There are two directions of research (herbal and placebo medicine) considered to be of interest due to the actual trend toward natural medicine and against chemicals and associated drugs. For quantitative research, the research tool used was that of the Neurasites Questionnaire Survey (NQS). The obtained results prove the efficacy of treatment by reducing the duration of headache attacks, diminishing pain intensity and decreasing the frequency of migraine episodes. Further research development should focus on other dosages and treatment schemes and on other similar natural products to be used in migraine attack treatment.
PubMed: 38929892
DOI: 10.3390/jcm13123364 -
Journal of Personalized Medicine May 2024Transcranial direct current stimulation (tDCS) is emerging as a promising non-invasive intervention for tinnitus by aiming to modulate abnormal brain activity. This...
Transcranial direct current stimulation (tDCS) is emerging as a promising non-invasive intervention for tinnitus by aiming to modulate abnormal brain activity. This study investigated the efficacy of dual-session tDCS for the relief of perception, distress, and loudness in patients with severe chronic subjective tinnitus and assessed the duration of tinnitus suppression effects compared to single-session and control groups over a 2-month follow-up. In a prospective, randomized, single-blind, placebo-controlled trial, 30 participants with severe chronic subjective tinnitus underwent bifrontal tDCS. The control group (n = 9), single-session group (n = 10), and dual-session group (n = 11) received 2 mA stimulation for 20 min per session, twice a week for one month. The treatment response was monitored weekly using the Visual Analogue Scale (VAS), with additional assessments using the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI) at the fourth and eighth weeks. The single- and dual-session groups showed statistically significant improvements in VAS, THI, and BDI scores compared to the control group. THI and BDI scores showed a significant difference between the single- and dual-session groups. The dual-session group demonstrated a more sustained tinnitus suppression effect than the single-session group. tDCS has been validated as an effective intervention for the suppression of tinnitus, with the dual-session protocol showing longer-term benefits. These findings support the potential of tDCS as a treatment for tinnitus, particularly in dual-session applications.
PubMed: 38929798
DOI: 10.3390/jpm14060577 -
Medicina (Kaunas, Lithuania) Jun 2024The focus on mild cognitive dysfunction in adults is of great interest, given the risk of worsening and conversion to dementia. Cognitive dysfunctions are characterized... (Randomized Controlled Trial)
Randomized Controlled Trial
The focus on mild cognitive dysfunction in adults is of great interest, given the risk of worsening and conversion to dementia. Cognitive dysfunctions are characterized by a decrease in the weight and volume of the brain, due to cortical atrophy, with a widening of the grooves and flattening of the convolutions. Brain atrophy that mainly involves the hippocampus is related to the progression of cognitive impairment and the conversion from mild cognitive dysfunction to dementia. Currently, there is no treatment for MCI. Results from a trial on Alzheimer's disease (ASCOMALVA trial) suggest that a sustained cholinergic challenge can slow the progression of brain atrophy typical of Alzheimer's disease associated with vascular damage. This study intends to evaluate the efficacy of choline alphoscerate in patients with mild cognitive impairment (MCI) and associated vascular damage, in stabilizing and/or slowing brain atrophy typical of adult-onset cognitive dysfunction, and in improving and/or slowing the progression of cognitive and behavioral symptoms associated with MCI. : This randomized controlled trial will recruit 60 patients that will be evaluated and randomized in a 1:1 ratio to receive choline alphoscerate (1200 mg/day) or placebo, for 12 months. Analyses will be carried out using SPSS vesion No 26 the Statistician in charge of this study, with the statistical significance level chosen as 0.05. : This trial may provide evidence about the efficacy of treatment with the cholinergic precursor choline alphoscerate in patients with mild cognitive dysfunction. The results of this study will be published in peer-reviewed journals. EudraCT number: 2020-000576-38.
Topics: Humans; Cognitive Dysfunction; Glycerylphosphorylcholine; Male; Female; Aged; Middle Aged; Cholinergic Agents; Randomized Controlled Trials as Topic
PubMed: 38929542
DOI: 10.3390/medicina60060925 -
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