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GABA Supplementation, Increased Heart-Rate Variability, Emotional Response, Sleep Efficiency and Reduced Depression in Sedentary Overweight Women Undergoing Physical Exercise: Placebo-Controlled, Randomized Clinical Trial. 补充 GABA 可提高进行体育锻炼的久坐超重女性的心率变异性、情绪反应、睡眠效率并减少抑郁:安慰剂对照随机临床试验》。
IF 1.9 Q3 NUTRITION & DIETETICS Pub Date : 2024-01-01 Epub Date: 2024-02-06 DOI: 10.1080/19390211.2024.2308262
Aparecida Patricia Guimarães, Helen Seidel, Larissa Vitalina de Medeiros Pires, Cristina Oliveira Trindade, Raianne Dos Santos Baleeiro, Perciliany Martins de Souza, Fernanda Guimarães Drummond E Silva, Daniel Barbosa Coelho, Lenice Kappes Becker, Emerson Cruz de Oliveira

Gamma-aminobutyric acid (GABA) serves as a pivotal neurotransmitter implicated in the pathogenesis of stress, anxiety, sleep-related disorders, and heart rate (HR) reactions. Heart-rate variability (HRV), modulated by the sympathetic and parasympathetic branches of the autonomic nervous system (ANS), offers insights into cardiac autonomic control and cardiovascular well-being. The present study aimed to explore the impact of GABA supplementation on emotional metrics, sleep quality, and HRV in sedentary women with overweight or obesity partaking in physical exercise. A randomized, double-blind, placebo-controlled clinical trial was undertaken involving 30 sedentary women with overweight or obesity. Volunteers were assigned randomly to two groups: the intervention group receiving GABA (200 mg) once daily for a total of 90 supplementation doses, and the placebo group. Both groups engaged in physical exercise, while the supplementation regimen spanned 90 days. Assessments were conducted at three intervals: baseline (T0), midway through the study (T45), and study culmination (T90). Following 90 days of GABA supplementation, the intervention group demonstrated enhancements in habitual sleep efficiency, as indicated by reductions in Pittsburgh Sleep Quality Index (PSQI) scores. Moreover, an improved emotional response was observed, characterized by diminished negative affect. GABA supplementation yielded ameliorations in depression scores as per the Depression, Anxiety, and Stress Scale (DASS-21). Notably, an augmented HRV was noted, attributed to heightened parasympathetic autonomic nervous system predominance. GABA supplementation elicited noteworthy enhancements in heart rate variability, emotional response, depression mitigation, and sleep efficiency following a 90-day supplementation.

γ-氨基丁酸(GABA)是一种关键的神经递质,与压力、焦虑、睡眠相关疾病和心率(HR)反应的发病机制有关。心率变异性(HRV)由自律神经系统(ANS)的交感神经和副交感神经分支调节,有助于了解心脏自律神经控制和心血管健康状况。本研究旨在探讨 GABA 补充剂对参加体育锻炼的超重或肥胖久坐妇女的情绪指标、睡眠质量和心率变异的影响。本研究进行了一项随机、双盲、安慰剂对照临床试验,涉及 30 名超重或肥胖的久坐妇女。志愿者被随机分配到两组:干预组和安慰剂组,前者每天服用一次 GABA(200 毫克),共服用 90 次。两组均进行体育锻炼,而补充剂的使用则持续 90 天。评估在三个时间间隔进行:基线(T0)、研究中期(T45)和研究结束(T90)。在服用 GABA 补充剂 90 天后,干预组的习惯性睡眠效率有所提高,匹兹堡睡眠质量指数(PSQI)得分有所下降。此外,还观察到情绪反应有所改善,消极情绪减少。根据抑郁、焦虑和压力量表(DASS-21),补充 GABA 可改善抑郁评分。值得注意的是,心率变异增强,这归因于副交感神经自律神经系统占主导地位。在补充 GABA 90 天后,心率变异性、情绪反应、抑郁缓解和睡眠效率都有显著提高。
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引用次数: 0
Effect of L-Methylfolate Supplementation on Sleep for Patients with Reduced Methylenetetrahydrofolate Reductase Activity. 补充 L-甲基叶酸对亚甲四氢叶酸还原酶活性降低患者睡眠的影响
IF 1.9 Q3 NUTRITION & DIETETICS Pub Date : 2024-01-01 Epub Date: 2024-03-25 DOI: 10.1080/19390211.2024.2327541
Alex S Carmon, Russell J Amato, Seema M Patel, Shannon W Finks

Introduction: Clinicians have limited options outside controlled substances to address sleep disturbance, which left untreated can negatively affect patient outcomes in cardiovascular health, mental health, immunologic function, and more. For some, genetic factors may influence sleep disturbances. L-methylfolate, the active form of folate, plays a critical role in regulation of monoamine neurotransmitters known to have significant impact on sleep regulation: dopamine, serotonin, norepinephrine. Single nucleotide polymorphisms of the enzyme methylene-tetrahydrofolate-reductase are common and can impact monoamine production. The goal of this study was to evaluate effects of L-methylfolate supplementation on sleep in a cohort with reduced methylene tetrahydrofolate reductase (MTHFR) activity.

Methods: A retrospective cohort of patients being treated with L-methylfolate in a concierge medical clinic setting was studied. Patients presenting with sleep complaints were evaluated using the Patient-Reported Outcomes Measurement Information System at baseline. Patients with known MTHFR polymorphisms at either C667T and/or A1298C were recommended 5 mg of L-methylfolate daily and were reevaluated at 2 wks, at 4 wks, and at 8 wks of supplementation. Statistical comparisons were made utilizing ANOVA and T-test comparisons.

Results: Ten were included in the final cohort: six male and four female, average age 43 ± 16 years. Beginning at wk 2, average sleep disturbance improved significantly by -6.94 points (p = 0.005) and by 8 wks, all patients had improvement with a -14.34 change in disturbance from baseline (p = 0.001).

Conclusion: Improvement in sleep disturbance was seen in both low and intermediate function phenotypes. L-methylfolate may be useful for improving sleep in patients with MTHFR polymorphism.

简介:临床医生在解决睡眠障碍问题时,除了使用受管制药物外,可供选择的治疗方案非常有限,而睡眠障碍如不及时治疗,会对患者的心血管健康、精神健康、免疫功能等产生负面影响。对于某些人来说,遗传因素可能会影响睡眠障碍。L-甲基叶酸是叶酸的活性形式,在调节已知对睡眠调节有重大影响的单胺类神经递质(多巴胺、5-羟色胺和去甲肾上腺素)方面起着关键作用。亚甲基四氢叶酸还原酶的单核苷酸多态性很常见,会影响单胺的产生。本研究旨在评估补充 L-甲基叶酸对亚甲四氢叶酸还原酶(MTHFR)活性降低的人群睡眠的影响:研究对象是在一家高级医疗诊所接受 L-甲基叶酸治疗的患者。基线时,使用患者报告结果测量信息系统对出现睡眠不适的患者进行评估。建议已知 MTHFR 多态性为 C667T 和/或 A1298C 的患者每天服用 5 毫克 L-甲基叶酸,并在补充 2 周、4 周和 8 周时进行重新评估。统计比较采用方差分析和 T 检验:结果:最后一组共有 10 人:6 名男性和 4 名女性,平均年龄为 43 ± 16 岁。从第 2 周开始,平均睡眠障碍明显改善了-6.94 分(p = 0.005),到第 8 周,所有患者的睡眠障碍都有所改善,与基线相比,变化了-14.34 分(p = 0.001):结论:低功能和中功能表型患者的睡眠障碍均有所改善。L-甲基叶酸可能有助于改善 MTHFR 多态性患者的睡眠。
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引用次数: 0
A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults. 一项随机、双盲、交叉研究,旨在调查健康成人体内缓释褪黑素与速释褪黑素的药代动力学比较。
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2023-05-07 DOI: 10.1080/19390211.2023.2206475
Jonathan G Mun, Dan Wang, Denise L Doerflein Fulk, Mina Fakhary, Scott J Gualco, Ryan W Grant, Susan Hazels Mitmesser

Exogenous melatonin can be helpful for treatment of some sleep disorders. However, immediate-release formulations are rapidly absorbed and cleared from the body making it difficult to provide coverage for an entire sleep period. Extended-release melatonin formulations can better mimic the naturally occurring melatonin profile and increase efficacy, but few studies have reported on their pharmacokinetics. To assess the pharmacokinetics of extended-release melatonin, we conducted a randomized, double-blind, crossover study of extended-release melatonin (4 mg) compared to immediate-release melatonin (4 mg) in 18 healthy adults, ages 18-65 years. Participants received immediate-release or extended-release melatonin in clinic after an 8 h fast, and blood samples were taken over a 10-h period. After a 7-day washout period, the same procedures were repeated with the melatonin form not previously received. Extended-release melatonin had a longer time to peak concentration (1.56 vs 0.6 h) and elimination half-life (1.63 vs 0.95 h) compared with immediate-release melatonin. Maximum concentration was lower for extended-release melatonin compared with immediate-release melatonin (7581 pg/mL vs 13120 pg/mL). Extended-release melatonin raised melatonin levels in as little as 15 min and sustained elevated melatonin levels (>300 pg/mL) for 6 h before falling below 50 pg/mL by 9 h. No clinically relevant adverse events were observed, and safety parameters remained within normal ranges for both formulations. The pharmacokinetic profile of this extended-release melatonin formulation suggests that it could be used for future efficacy studies of melatonin and sleep outcomes. This trial is registered at ClinicalTrials.gov, NCT04067791.

外源性褪黑素有助于治疗某些睡眠障碍。然而,速释制剂会迅速被人体吸收和清除,因此难以覆盖整个睡眠期。缓释褪黑素制剂能更好地模拟天然褪黑素的特征并提高疗效,但有关其药代动力学的研究报告很少。为了评估缓释褪黑素的药代动力学,我们对 18 名 18-65 岁的健康成年人进行了一项随机、双盲、交叉研究,将缓释褪黑素(4 毫克)与速释褪黑素(4 毫克)进行比较。参与者禁食 8 小时后在诊所接受速释或缓释褪黑素治疗,并在 10 小时内采集血液样本。经过 7 天的冲洗期后,重复同样的程序,使用之前未服用过的褪黑素。与速释褪黑素相比,缓释褪黑素的达峰时间(1.56 小时对 0.6 小时)和消除半衰期(1.63 小时对 0.95 小时)更长。与速释褪黑素相比,缓释褪黑素的最大浓度较低(7 581 pg/mL vs 13120 pg/mL)。缓释褪黑素可在15分钟内提高褪黑素水平,并在6小时内维持较高的褪黑素水平(>300 pg/mL),然后在9小时内降至50 pg/mL以下。这种褪黑素缓释制剂的药代动力学特征表明,它可用于未来褪黑素和睡眠结果的疗效研究。该试验已在 ClinicalTrials.gov 登记,编号为 NCT04067791。
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引用次数: 0
Correction. 修正。
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2023-12-07 DOI: 10.1080/19390211.2023.2286740
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引用次数: 0
Prebiotics, Probiotics and Postbiotics: The Changing Paradigm of Functional Foods. 益生菌、益生菌和益后菌:不断变化的功能食品范式。
IF 1.9 Q3 NUTRITION & DIETETICS Pub Date : 2024-01-01 Epub Date: 2024-06-16 DOI: 10.1080/19390211.2024.2363199
Naveen Kango, Suresh Nath

The rampant use of antibiotics has led to the emergence of multidrug resistance and is often coupled with gut dysbiosis. To circumvent the harmful impact of antibiotics, probiotics have emerged as an effective intervention. However, while the new probiotics are being added to the list, more recently, the nature and role of their counterparts, viz. prebiotics, postbiotics and parabiotics have also drawn considerable attention. As such, intricate relationships among these gut-biotics vis-à-vis their role in imparting health benefits is to be delineated in a holistic manner. Prebiotic dietary fibers are selectively fermented by probiotics and promote their colonization in the gut. The proliferation of probiotics leads to production of fermentation by-products (postbiotics) which affect the growth of enteropathogens by lowering the pH and producing inhibitory bacteriocins. After completing life-cycle, their dead remnants (parabiotics e.g. exopolysaccharides and cell wall glycoproteins) also inhibit adhesion and biofilm formation of pathogens on the gut epithelium. These beneficial effects are not just endemic to gut but a systemic response is witnessed at different gut-organ axes. Thus, to decipher the role of probiotics, it is imperative to unravel the interdependence between these components. This review elaborates on the recent advancements on various aspects of these gut-biotics and the mechanism of potential attributes like anti-oxidant, anti-inflammatory, anti-neoplastic, anti-lipidemic and anti-hyperglycemic benefits.

抗生素的大量使用导致了多种药物耐药性的出现,并常常与肠道菌群失调同时发生。为了避免抗生素的有害影响,益生菌已成为一种有效的干预措施。然而,在新的益生菌不断出现的同时,与之相对应的益生菌,即益生元、后益生元和副益生元的性质和作用最近也引起了人们的广泛关注。因此,这些肠道生物之间错综复杂的关系,以及它们在提供健康益处方面的作用,需要以一种整体的方式加以界定。益生元膳食纤维会被益生菌选择性地发酵,并促进它们在肠道中的定植。益生菌的增殖会产生发酵副产品(后益生菌),通过降低 pH 值和产生抑制性细菌素来影响肠道病原体的生长。在完成生命周期后,其死亡残留物(副生物素,如外多糖和细胞壁糖蛋白)还能抑制病原体在肠道上皮细胞上的粘附和生物膜的形成。这些有益作用并不只是肠道特有的,而是在不同的肠道-器官轴上出现的系统性反应。因此,要解读益生菌的作用,就必须揭示这些成分之间的相互依存关系。本综述阐述了这些肠道益生菌各方面的最新进展,以及抗氧化、抗炎、抗肿瘤、降血脂和降血糖等潜在特性的机理。
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引用次数: 0
Improved in vitro Hemagglutination Assays Utilizing P-Type and Type 1 Uropathogenic Escherichia coli to Evaluate Bacterial Anti-Adhesion Activity of Cranberry Products. 用p型和1型尿路致病性大肠杆菌改进体外血凝试验评价蔓越莓产品细菌抗黏附活性
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2023-11-14 DOI: 10.1080/19390211.2023.2276962
Scott Bosley, Christian G Krueger, Andrew Birmingham, Amy B Howell, Jess D Reed

Cranberries have a long history of use in the prevention of urinary tract infections. Cranberry products vary in proanthocyanidin content, a compound implicated in preventing the adhesion of uropathogenic Escherichia coli (E. coli) to uroepithelial cells. Testing is routinely done by cranberry product formulators to evaluate in vitro bacterial anti-adhesion bioactivity, shelf-life, and potential efficacy of cranberry products for consumer use to maintain urinary tract health. Hemagglutination assays evaluate the anti-adhesion bioactivity of cranberry products by determining how effectively the products prevent agglutination of specific red blood cells with E. coli expressing P-type and Type 1 fimbriae. The current study sought to improve upon an established anti-adhesion assay method by expanding the number of E. coli strains used to broaden potential in vivo efficacy implications and presenting results using photomicrographic data to improve accuracy and build databases on products that are routinely tested. Different lots of cranberry powder ingredient and two formulated products were tested independently for anti-adhesion activity using the established method and the improved method. Positive harmonization of results on the same samples using rigorous controls was achieved and provides the substantiation needed for the cranberry industry to utilize the improved, rapid in vitro testing method to standardize cranberry products for sufficient anti-adhesion bioactivity and maintain consumer confidence.

蔓越莓在预防尿路感染方面有着悠久的历史。蔓越莓产品的原花青素含量各不相同,原花青素是一种与防止尿路致病性大肠杆菌(E. coli)粘附尿路上皮细胞有关的化合物。蔓越莓产品配方师通常会进行测试,以评估蔓越莓产品的体外抗细菌粘附生物活性、保质期和消费者使用蔓越莓产品保持尿道健康的潜在功效。血凝试验通过确定产品如何有效地防止特定红细胞与表达p型和1型菌毛的大肠杆菌的凝集来评估蔓越莓产品的抗黏附生物活性。目前的研究试图通过扩大大肠杆菌菌株的数量来扩大潜在的体内功效,并使用显微摄影数据来提高准确性,并建立常规测试产品的数据库,从而改进已建立的抗粘附测定方法。采用所建立的方法和改进后的方法,对不同批次蔓越莓粉原料和两种配方产品的抗黏附活性进行了独立测试。通过严格的控制,对相同样品的结果进行了积极的协调,并为蔓越莓行业利用改进的快速体外测试方法标准化蔓越莓产品提供了必要的依据,以获得足够的抗粘附生物活性,并保持消费者的信心。
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引用次数: 0
Grass-Fed and Non-Grass-Fed Whey Protein Consumption Do Not Attenuate Exercise-Induced Muscle Damage and Soreness in Resistance-Trained Individuals: A Randomized, Placebo-Controlled Trial. 草饲和非草饲乳清蛋白的摄入不会减轻阻力训练个体运动引起的肌肉损伤和酸痛:一项随机安慰剂对照试验。
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2023-11-20 DOI: 10.1080/19390211.2023.2282470
Matthew J Barenie, Albaro Escalera, Stephen J Carter, Hope E Grange, Hunter L Paris, Danielle Krinsky, Abigail S Sogard, Zachary J Schlader, Alyce D Fly, Timothy D Mickleborough

Eccentric muscle contractions can cause structural damage to muscle cells resulting in temporarily decreased muscle force production and soreness. Prior work indicates pasture-raised dairy products from grass-fed cows have greater anti-inflammatory and antioxidant properties compared to grain-fed counterparts. However, limited research has evaluated the utility of whey protein from pasture-raised, grass-fed cows to enhance recovery compared to whey protein from non-grass-fed cows. Therefore, using a randomized, placebo-controlled design, we compared the effect of whey protein from pasture-raised, grass-fed cows (PRWP) to conventional whey protein (CWP) supplementation on indirect markers of muscle damage in response to eccentric exercise-induced muscle damage (EIMD) in resistance-trained individuals. Thirty-nine subjects (PRWP, n = 14; CWP, n = 12) completed an eccentric squat protocol to induce EIMD with measurements performed at 24, 48, and 72 h of recovery. Dependent variables included: delayed onset muscle soreness (DOMS), urinary titin, maximal isometric voluntary contraction (MIVC), potentiated quadriceps twitch force, countermovement jump (CMJ), and barbell back squat velocity (BBSV). Between-condition comparisons did not reveal any significant differences (p ≤ 0.05) in markers of EIMD via DOMS, urinary titin, MIVC, potentiated quadriceps twitch force, CMJ, or BBSV. In conclusion, neither PRWP nor CWP attenuate indirect markers of muscle damage and soreness following eccentric exercise in resistance-trained individuals.

偏心肌肉收缩会对肌肉细胞造成结构性损伤,导致肌肉力量产生暂时减少和酸痛。先前的研究表明,与谷物喂养的奶牛相比,草饲奶牛生产的牧场乳制品具有更强的抗炎和抗氧化特性。然而,有限的研究已经评估了来自牧场饲养的草饲奶牛的乳清蛋白与来自非草饲奶牛的乳清蛋白相比,在提高恢复方面的效用。因此,采用随机、安慰剂对照设计,我们比较了来自牧场饲养的草饲奶牛(PRWP)的乳清蛋白和传统乳清蛋白(CWP)补充对阻力训练个体偏心运动诱导的肌肉损伤(EIMD)的间接肌肉损伤标志物的影响。39名受试者(PRWP, n = 14;CWP, n = 12)完成了偏心深蹲方案,在恢复后24、48和72小时进行测量,以诱发EIMD。相关变量包括:迟发性肌肉酸痛(DOMS)、尿titin、最大等长自主收缩(MIVC)、增强股四头肌抽搐力、反向运动跳跃(CMJ)和杠铃后蹲速度(BBSV)。通过迟发性肌肉酸痛、尿titin、MIVC、增强股四头肌抽搐力、CMJ或BBSV的EIMD标记物在两组间比较中无显著差异(p≤0.05)。总之,PRWP和CWP都不能减弱阻力训练个体偏心运动后肌肉损伤和酸痛的间接标志。
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引用次数: 0
Open, Observational, Single-Arm, Multicenter Study Assessing the Effectiveness of a Dietary Supplement Containing Hydrolyzed Collagen, Chondroitin Sulfate, and Glucosamine for Osteoarthritis Pain Reduction. 开放式、观察性、单臂、多中心研究:评估含水解胶原蛋白、硫酸软骨素和氨基葡萄糖的膳食补充剂对减轻骨关节炎疼痛的效果。
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2024-01-05 DOI: 10.1080/19390211.2023.2284982
Jordi Puigdellívol Grifell, Carme Comellas Berenguer, Gilbert Steinbacher, Tomislav Kranjcec, Pedro Álvarez Díaz, Antoni López Pujol, Asunción Acosta Pereira, Maximiliano Sánchez Martos, José Reyes Fernández Velázquez, Miguel Ángel Esparza Pagán, Víctor Lainez Romo, Luis Payán Martín, Jordi Giménez Gonzalo, Christian Carreras Vidal, José David Sulbarán, Jaume Oliveras Riera

Osteoarthritis (OA) is an age-related degenerative joint disease with a great impact on patients' well-being and quality of life. This is an observational, open, single-arm multicenter study aimed to evaluate the effectiveness of a nutritional supplement in patients with knee and/or hip OA. A total of 186 patients were recruited from Spanish centers and received a supplement containing hydrolyzed collagen (3000 mg), chondroitin sulfate (800 mg), glucosamine sulfate (700 mg), turmeric extract (250 mg) and devil's claw (150 mg), once daily during 6 months. The primary outcome was the patients' self-perceived pain in the affected joints measured with a visual analogue scale (VAS). Secondary outcome was the patient's functioning, measured with the Lequesne Functional Index and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Participants showed a significant reduction in self-perceived pain after 3 (mean reduction ± standard deviation, 1.99 ± 1.05) and 6 months (3.57 ± 1.39) of treatment (p < 0.0001 in both comparisons). Lequesne Functional Index score was significantly reduced at 3 months (3.86 ± 2.94) and at 6 months (6.73 ± 4.30) of treatment (p < 0.0001 in both comparisons). The WOMAC index was also significantly reduced after 3 (14.24 ± 10.04) and 6 months (26.43 ± 17.35) of treatment (p < 0.0001 in both comparisons). Significant reductions in WOMAC subdomains (p < 0.0001 in all comparisons) were observed. No severe adverse events were reported during the study. The main results arising from this study show that this nutritional supplementation can improve OA-related symptoms and physical function with a good safety profile in patients with hip and/or knee OA.

骨关节炎(OA)是一种与年龄相关的退行性关节疾病,对患者的健康和生活质量有很大影响。这是一项观察性、开放式、单臂多中心研究,旨在评估营养补充剂对膝关节和/或髋关节 OA 患者的疗效。该研究从西班牙各中心共招募了 186 名患者,他们在 6 个月内每天一次服用含有水解胶原蛋白(3000 毫克)、硫酸软骨素(800 毫克)、硫酸氨基葡萄糖(700 毫克)、姜黄提取物(250 毫克)和魔鬼爪(150 毫克)的营养补充剂。主要结果是患者通过视觉模拟量表(VAS)对受影响关节疼痛的自我感觉。次要结果是患者的功能,采用勒克斯功能指数和西安大略与麦克马斯特大学关节炎指数(WOMAC)进行测量。经过 3 个月和 6 个月的治疗(分别为 3.57 ± 1.39 和 3.99 ± 1.05),参与者的自我感觉疼痛明显减轻。
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引用次数: 0
Effects of a Nutraceutical Multicompound, with Probiotics, Hericium, PEA, and Undaria in Patients with Irritable Bowel Syndrome. 肠易激综合征患者服用含有益生菌、Hericium、PEA 和 Undaria 的复合营养素的效果。
IF 1.9 Q3 NUTRITION & DIETETICS Pub Date : 2024-01-01 Epub Date: 2024-01-08 DOI: 10.1080/19390211.2023.2296106
Antonio Romano, Linda Balestrini, Giulia Della Scala, Lucia Chico, Alessio Bertini, Matilde Cangioli, Federico Ciapparelli, Enzo Ciardella, Claudia Congestrí, Valentina Dinelli, Fabio Donati, Massimo Ficini, Cecilia Giovanetti, Federico Nannicini, Alessandro Pasquali, Andrea Pieraccini

Irritable bowel syndrome (IBS) is a functional gastrointestinal condition. Probiotics and other nutraceutical compounds can have specific indications in the context of IBS. A retrospective analysis was conducted on 123 IBS patients in order to evaluate the effects of an oral probiotic-based dietary supplement (Colicron, one cps/day for 4 wk) on stool consistency and pain intensity. Different time points were defined as follows: baseline (T0), 2 wk of treatment (T2), and 4 wk of treatment (T4). Stool consistency was assessed by using the Bristol Stool Scale. Pain intensity was evaluated by the Visual Analogue Scale (VAS). Patients who were initially categorized as normal retained regular bowel movements throughout the study. Both patients with constipation and diarrhea showed an improvement in the Bristol Stool Scale. The score increased from 1.5 ± 0.5 to 3.3 ± 0.7 (p < 0.001) and decreased from 6.5 ± 0.7 to 4.3 ± 0.9 (p < 0.001) at T4, respectively, compared to T0. The VAS score for pain in the pooled IBS patients improved from 6.7 ± 2.2 to 2.8 ± 1.9 at T0 vs T4 (p < 0.001), with a similar trend also observed when patients were categorized based on stool consistency: normal (from 5.2 ± 1.9 to 2.9 ± 1.7), constipation (from 7.5 ± 1.3 to 3.2 ± 2.2), and diarrhea (6.7 ± 2.3 to 2.5 ± 1.9) (p < 0.001).

Colicron could be useful in symptom relief, reducing abdominal pain and improving stool consistency of IBS patients. However, further controlled clinical trials are needed to confirm these preliminary findings.

肠易激综合征(IBS)是一种功能性胃肠道疾病。益生菌和其他营养保健品对肠易激综合征有特殊的适应症。我们对 123 名 IBS 患者进行了回顾性分析,以评估口服益生菌膳食补充剂(Colicron,1 cps/天,4 周)对大便稠度和疼痛强度的影响。不同的时间点定义如下:基线(T0)、治疗 2 周(T2)和治疗 4 周(T4)。大便稠度采用布里斯托尔大便量表进行评估。疼痛强度采用视觉模拟量表(VAS)进行评估。最初被归类为正常的患者在整个研究过程中都保持了规律的排便。便秘和腹泻患者的布里斯托大便量表均有改善。分值从 1.5 ± 0.5 增加到 3.3 ± 0.7(p p vs T4(p p
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引用次数: 0
Comparative Bioavailability and Benefits on Mental Functions of Novel Extended-Release Caffeine Capsules against Immediate-Release Caffeine Capsules: An Open-Label, Randomized, Cross-over, Single-Dose Two-Way Crossover Study. 新型缓释咖啡因胶囊与速释咖啡因胶囊的生物利用度比较及对精神功能的益处:一项开放标签、随机、交叉、单剂量双向交叉研究。
IF 2.5 Q2 Agricultural and Biological Sciences Pub Date : 2024-01-01 Epub Date: 2023-01-05 DOI: 10.1080/19390211.2022.2160529
Shefali Thanawala, Rajat Shah, R Abiraamasundari, R Senthurselvi, Prabakaran Desomayanandam

Present study aimed compared pharmacokinetic profile of sustained-release CaffXtend® capsules (SR-Caffeine) with immediate-release caffeine capsules (IR-Caffeine), and the effect of SR-caffeine on memory, motivation, concentration, and attention. This open-label, randomized, single-dose, two-treatment, two-sequence, two-period, two-way crossover oral bioavailability study block randomized (1:1) healthy subjects (N = 15) to receive SR-Caffeine (200 mg) and IR-Caffeine (200 mg). Blood samples were collected at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36 and 48 h in each period. Primary study outcome included comparing relative bioavailability of SR-Caffeine 200 mg and IR-Caffeine 200 mg under fasting conditions, and changes in caffeine research visual analogue scale (Caff-VAS) scores ('relaxed', 'alert', 'jittery', 'tired', 'tense', 'headache', 'overall mood' and 'mentally fatigued') were also evaluated. Fifteen subjects completed the study. Mean tmax was 4.08 ± 2.13h for SR-Caffeine compared to 0.83 ± 0.39h for IR-Caffeine, (p < 0.0001). Similarly, mean t½ was 7.07 ± 3.48h for SR-Caffeine compared to 5.78 ± 2.11h for IR-Caffeine (p = 0.04189). However, total exposure was similar for SR-Caffeine and IR-Caffeine (90% CI: 89.89-120.50% to 94.49-123.82% for geometric least square mean of ln-transformed AUC0-t and AUC0-∞). In the Caff-VAS evaluation, the SR-Caffeine group showed significantly better scores for 'jitteriness', 'tiredness', 'alertness' and 'overall mood' for 8-12 h than the IR-Caffeine group. No adverse events were reported. Results demonstrated sustained release of caffeine over 24 h from SR-Caffeine as compared to IR-Caffeine, which showed significant improvements in the scores for 'relaxed', 'alertness' and 'overall mood' and significantly lower scores for the parameters-'jittery' and 'tired' for extended period.Clinical trial registration: CTRI/2021/06/034185.

本研究旨在比较缓释型CaffXtend®胶囊(SR-Caffeine)和速释型咖啡因胶囊(IR-Caffeine)的药代动力学特征,以及sr -咖啡因对记忆、动机、注意力和注意力的影响。这项开放标签、随机、单剂量、两治疗、两顺序、两期、双向交叉口服生物利用度研究随机(1:1)健康受试者(N = 15)接受sr -咖啡因(200 mg)和ir -咖啡因(200 mg)。于每个周期0.25、0.50、0.75、1、1.5、2、3、4、5、6、8、10、12、24、36、48 h采集血样。主要研究结果包括在禁食条件下比较sr -咖啡因200毫克和ir -咖啡因200毫克的相对生物利用度,并评估咖啡因研究视觉模拟量表(caffa - vas)评分的变化(“放松”、“警觉”、“紧张”、“疲倦”、“紧张”、“头痛”、“整体情绪”和“精神疲劳”)。15名受试者完成了这项研究。sr -咖啡因组的平均tmax为4.08±2.13h, ir -咖啡因组为0.83±0.39h (p½为7.07±3.48h, sr -咖啡因组为5.78±2.11h, p = 0.04189)。然而,sr -咖啡因和ir -咖啡因的总暴露量相似(ln变换的AUC0-t和AUC0-∞的几何最小二乘平均值的90% CI: 89.89-120.50%至94.49-123.82%)。在咖啡因- vas评估中,sr -咖啡因组在8-12小时的“紧张”、“疲劳”、“警觉性”和“整体情绪”方面的得分明显高于ir -咖啡因组。无不良事件报告。结果显示,与ir -咖啡因相比,sr -咖啡因在24小时内持续释放咖啡因,在“放松”、“警觉性”和“整体情绪”方面的得分显著提高,而在“紧张”和“疲劳”等参数上的得分明显降低。临床试验注册:CTRI/2021/06/034185。
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Journal of Dietary Supplements
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