Safety and Efficacy of AlphaWave^® L-Theanine Supplementation for 28 Days in Healthy Adults with Moderate Stress: A Randomized, Double-Blind, Placebo-Controlled Trial.

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY Neurology and Therapy Pub Date : 2024-08-01 Epub Date: 2024-05-17 DOI:10.1007/s40120-024-00624-7

Marc Moulin, David C Crowley, Lora Xiong, Najla Guthrie, Erin D Lewis

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Abstract

Background: Prolonged periods of stress may lead to negative health consequences. AlphaWave^® L-Theanine was safe and efficacious during an acute stress challenge. However, double-blind, placebo-controlled clinical trials investigating the longer term effects of L-theanine supplementation on stress are warranted.

Methods: Thirty healthy adults (18-65 years) with moderate stress were randomized to AlphaWave^® L-Theanine (400 mg L-theanine/day) or placebo (n = 15/group) for 28 days. Stress was assessed by salivary cortisol, Perceived Stress Scale (PSS) and Depression, Anxiety and Stress Scale-21; sleep was assessed by the Healthy People Sleep Quality Index and actigraphy device; cognition was assessed by Computerized Mental Performance Assessment System; mood was assessed by Profile of Mood States. All outcomes were measured at baseline, Days 14 and 28. Safety included vital signs, clinical chemistry, haematology and adverse events (AEs).

Results: All AEs were resolved by the end of the study period or upon subsequent follow up, and out of range laboratory values and changes in vital signs were deemed not clinically relevant following AlphaWave^® L-Theanine supplementation. Participants supplemented with AlphaWave^® L-Theanine had decreases of 12.92% (p = 0.051) and 17.98% (p = 0.04) in PSS scores after 14 and 28 days, respectively, while those on placebo had respective decreases of 9.74% (p = 0.061) and 17.88% (p = 0.009). There were no significant differences between groups for change in salivary cortisol. The AlphaWave^® L-Theanine group demonstrated decreased time asleep after 28 days and significantly reduced light sleep after 14 and 28 days compared to placebo (p ≤ 0.040). The AlphaWave^® L-Theanine group significantly improved by 21.79% and 21.33% in Stroop test correct reaction time after 14 and 28 days, respectively, while those on placebo improved after 28 days only (p = 0.005).

Conclusions: AlphaWave^® L-Theanine supplementation for 28 days was safe and significantly decreased perceived stress significantly decreased perceived stress and light sleep, improved sleep quality and enhanced cognitive attention in the studied population. Larger, randomized controlled trials with longer duration of AlphaWave^® L-Theanine supplementation are warranted to reduce inter-individual variability and the potential placebo effect.

Trial registration: ClinicalTrials.gov identifier, NCT05808595.

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在有中度压力的健康成人中连续 28 天补充 AlphaWave® L-Theanine 的安全性和有效性：一项随机、双盲、安慰剂对照试验。

背景：长时间的压力可能会对健康造成负面影响。AlphaWave® L-茶氨酸在急性压力挑战中安全有效。然而，还需要进行双盲、安慰剂对照临床试验，研究补充左旋茶氨酸对压力的长期影响：方法：30 名患有中度压力的健康成年人（18-65 岁）在 28 天内随机服用 AlphaWave® L-茶氨酸（400 毫克/天）或安慰剂（n = 15/组）。压力通过唾液皮质醇、感知压力量表（PSS）和抑郁、焦虑和压力量表-21进行评估；睡眠通过健康人睡眠质量指数和动觉仪进行评估；认知通过计算机化精神表现评估系统进行评估；情绪通过情绪状态档案进行评估。所有结果均在基线、第 14 天和第 28 天进行测量。安全性包括生命体征、临床化学、血液学和不良事件（AEs）：结果：所有不良反应均在研究期结束或后续随访时得到缓解，补充 AlphaWave® L-Theanine 后，超出范围的实验室值和生命体征变化被认为与临床无关。补充 AlphaWave® L-Theanine 的参与者在 14 天和 28 天后的 PSS 评分分别下降了 12.92% (p = 0.051) 和 17.98% (p = 0.04)，而服用安慰剂的参与者则分别下降了 9.74% (p = 0.061) 和 17.88% (p = 0.009)。各组之间唾液皮质醇的变化没有明显差异。与安慰剂相比，AlphaWave® L-Theanine 组在 28 天后睡眠时间减少，在 14 天和 28 天后浅睡眠显著减少（p ≤ 0.040）。AlphaWave® L-茶氨酸组的 Stroop 测试正确反应时间在 14 天和 28 天后分别明显改善了 21.79% 和 21.33%，而安慰剂组仅在 28 天后有所改善（p = 0.005）：结论：连续 28 天补充 AlphaWave® L-Theanine 是安全的，而且能显著降低研究对象的压力感，显著降低压力感和浅睡眠，改善睡眠质量，提高认知注意力。有必要进行更大规模的随机对照试验，延长补充 AlphaWave® L-Theanine 的持续时间，以减少个体间的差异和潜在的安慰剂效应：试验注册：ClinicalTrials.gov 识别码，NCT05808595。

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

期刊介绍： Aims and Scope Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice. Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted, it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model, this allows for the rapid and efficient communication of the latest research and reviews to support scientific discovery and clinical practice. Open Access All articles published by Neurology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. 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