NCT07311434已完成不适用
Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study
Athletic Greens International2 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2026年1月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Evening relaxation, sleep quality, and morning vitality
研究概览
简要总结
The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Age 25-59 years.
- •BMI ≥18.5 and ≤29.9 kg/m².
- •Currently experiencing issues with sleep quality, falling asleep, staying asleep, or waking during the night.
- •RU-SATED score ≤
- •Willing and able to follow the study protocol.
- •Willing to discontinue any other supplements (including nootropics, adaptogens, calming herbs), medications, herbal remedies, or over-the-counter sleep medications (e.g., zolpidem, diphenhydramine, Benadryl, ZzzQuil, Unisom, magnesium or melatonin products) used to assist with sleep during the study.
- •Agree to limit alcohol intake within approximately 4 hours of bedtime throughout participation.
- •Agree to limit caffeine intake to ≤400 mg/day (about 3-4 cups of coffee) and avoid ingestion of caffeine-containing products after 2:00 PM during the study period.
- •Generally healthy and not living with any uncontrolled chronic disease.
- •Resides in the United States.
- •Willing to discontinue any restricted products and adhere to all required study assessments.
排除标准
- •Diagnosed chronic sleep conditions (e.g., insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, sleep apnea).
- •Current use of sleep-tracking technology (e.g., wrist-worn trackers, rings, smartphone apps) that could influence sleep behavior or perception.
- •Women currently undergoing perimenopause or experiencing vasomotor symptoms (e.g., night sweats).
- •Use of hormone therapy (estrogen, progesterone, phytoestrogens) within the last 3 months.
- •Diagnosed psychiatric disorders including major depressive disorder with acute symptoms, bipolar disorder, generalized anxiety disorder with active symptoms, and PTSD with frequent nightmares.
- •Diagnosed neurodegenerative or chronic pain disorders, including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.
- •Regular prescribed stimulant use (e.g., amphetamines such as Adderall/Vyvanse; methylphenidate such as Ritalin/Concerta; modafinil/armodafinil).
- •Current use of CNS-activating antidepressants (bupropion, fluoxetine, venlafaxine, sertraline).
- •Current or recent use of cannabis or THC-containing products (recreational or medicinal marijuana, CBD with measurable THC, synthetic cannabinoids) within the past 30 days.
- •Employment in jobs disrupting nighttime sleep (e.g., night shift, rotating shift, excessive travel).
- •Current use of prescription sleep aids.
- •Introduction of any new sleep-related supplements, medications, herbal remedies, or melatonin products during the study.
- •Use of any prescription or OTC products with sedative properties (e.g., melatonin, diphenhydramine, doxylamine, valerian, ZzzQuil, Advil PM) within 4 weeks prior to enrollment or habitual use ≥3 times per week prior to enrollment unless investigator-approved.
- •Allergy or sensitivity to any study product ingredients.
- •Pregnant, breastfeeding, or trying to conceive during the study period.
- •History of substance abuse.
- •Heavy alcohol use (≥8 drinks/week for women or ≥15 drinks/week for men).
- •Participation in another research study now or within the next 7 weeks.
- •Any condition or behavior that, in the investigator's judgment, may interfere with study participation or data integrity.
研究组 & 干预措施
Sleep Supplement
Experimental
Sleep Supplement
干预措施: Sleep Supplement (Dietary Supplement)
Usual Diet
No Intervention
Usual Diet
结局指标
主要结局
Evening relaxation, sleep quality, and morning vitality
时间窗: Days 1, 3, 7, 14, 30
Assessed by subjective questionnaire
次要结局
未报告次要终点
研究者
研究点 (2)
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