连续八周每天饮用低剂量 CBD 饮料不会改善健康人的身体和精神健康状况:随机临床试验

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引用次数: 0

摘要

背景本研究探讨了在一种饮料中加入 60 或 30 毫克剂量的 CBD,并进一步补充 L-茶氨酸、维生素 E 和维生素 C,是否会改变健康人与一般健康和幸福相关的各种指标。方法这项双盲、安慰剂对照临床试验招募了健康的大学年龄受试者,将他们随机分为四个治疗组中的一个,在为期八周的时间里,他们每天饮用单一的 12 盎司饮料,其中包括:1)60 毫克 CBD(CBD60)加 L-茶氨酸;2)30 毫克 CBD(CBD30)加 L-茶氨酸;3)不含 CBD(CBD0)、仅含 L-茶氨酸;4)不含任何添加剂的车辆对照(PLAC)。调查对生活质量、幸福感、压力和睡眠进行了评估,而 Fitbit 腕部监测器则收集了身体活动和睡眠数据。无氧性能通过 Wingate 测试进行评估。空腹血液中的皮质醇、CRP 和肌酐浓度通过 ELISA 进行分析。结果 102 名健康参与者被随机分配到 CBD60(25 人)、CBD30(28 人)、CBD0(24 人)或 PLAC(25 人)组。各组在干预前的时间点没有差异,参与者的平均年龄为 24.4 ± 7.0 岁,平均体重指数为 23.9 ± 3.6 kg/m2。在为期八周的干预期后,CBD 治疗对生活质量、心理健康、压力感知、睡眠、身体成分、自愿体力活动和有氧运动表现等指标均无明显影响。此外,治疗组之间血清皮质醇、CRP 和肌酐的循环浓度相似。结论我们的研究结果表明,在含有 L-茶氨酸、维生素 E 和维生素 C 的饮料中添加 60 或 30 毫克的 CBD,每天饮用并持续 8 周,对于这些年轻的、普遍健康的人群来说耐受性良好,但 CBD 对生活质量、心理健康、感知压力和睡眠等主观测量指标,以及自愿体力活动、无氧运动表现、睡眠、血清皮质醇、CRP 和肌酐浓度等客观测量指标均无显著影响,无论是积极影响还是消极影响。试验注册:ClinicalTrials.gov.注册日期:12/01/2022;# NCT05189275;https://clinicaltrials.gov/study/NCT05189275?cond=CBD%20-focus&rank=1
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Low dose daily CBD beverage consumption for eight weeks does not improve physical and mental health measures in healthy individuals: A randomized clinical trial

Background

This study explores whether a 60 or 30 mg dose of CBD consumed in a beverage further supplemented with L-theanine, vitamin E, and vitamin C would alter various measures associated with general health and well-being in healthy individuals.

Methods

This double-blind, placebo-controlled clinical trial recruited healthy, college-aged subjects for randomization into one of four treatment groups where they consumed daily a single 12 ounce beverage for eight weeks containing 1) 60 mg CBD (CBD60) plus L-theanine; 2) 30 mg CBD (CBD30) plus L-theanine; 3) no CBD (CBD0), L-theanine alone, and 4) a vehicle control (PLAC) containing no additives. Surveys evaluated quality of life, wellbeing, stress, and sleep, while a Fitbit wrist monitor collected physical activity and sleep data. Anaerobic performance was evaluated with a Wingate test. Fasted blood concentrations of cortisol, CRP, and creatinine were analyzed with an ELISA. Pre-intervention time point differences were determined by ANOVA and a 4×2 ANOVA identified treatment effects.

Results

A total of 102 healthy participants were randomly assigned to CBD60 (n = 25), CBD30 (n = 28), CBD0 (n = 24), or PLAC (n = 25). There were no differences among the groups at the pre-intervention time point, and the average age of the participants was 24.4 ± 7.0 years, with an average BMI 23.9 ± 3.6 kg/m2. Following the eight-week intervention period, there were no significant CBD treatment effects with respect to quality of life, psychological wellbeing, perceived stress, sleep, body composition, voluntary physical activity, and anaerobic performance measures. Additionally, circulating concentrations of serum cortisol, CRP, and creatinine were similar between the treatment groups.

Conclusions

Our findings suggest that 60 or 30 mg of CBD added to a beverage containing L-theanine, vitamin E, and vitamin C; consumed daily for 8 weeks was well tolerated in this younger, generally healthy population, but CBD had no significant impact, either positive or negative, on subjective measures of quality of life, psychological well-being, perceived stress, and sleep; as well as objective measures of voluntary physical activity, anaerobic performance, sleep, serum cortisol, CRP, and creatinine concentrations. Trial Registration: ClinicalTrials.gov. Registered 12/01/2022; # NCT05189275; https://clinicaltrials.gov/study/NCT05189275?cond=CBD%20-focus&rank=1

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