NCT07345260招募中不适用
The Effects of a Nutritional Supplement on Sleep Quality
Athletic Greens International1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年1月2日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Tracked sleep activity
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female
- •Be aged 35-
- •Body Mass Index: ≥18.5 and ≤29.9 kg/m2
- •Anyone currently experiencing issues with falling asleep, staying asleep, or waking up during the night
- •Score of 7 or less on the RU-SATED validated sleep questionnaire.
- •Anyone willing to follow the study protocol.
- •Anyone willing to discontinue any other supplements (nootroptics, adaptogens, calming herbs), medications, herbal remedies, over the counter sleep medications [e.g., zolipidem, diphenhydramine (Benadryl or unisom), magnesium or melatonin products] used to assist with sleep for the duration of the study.
- •Agree to limit alcohol intake within ~4 hours of bedtime
- •Agree to limit caffeine intake to ≤ 400 mg/day (~3-4 cups of coffee) or ingestion of caffeine-containing products after 2:00 PM during the study period.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- •Resides in the United States.
排除标准
- •Anyone with a diagnosed chronic sleep condition, including but not limited to insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome (RLS), or sleep apnea.
- •Women currently undergoing perimenopause or experiencing vasomotor symptoms such as night sweats.
- •Use of hormone therapy (including estrogen, progesterone, or phytoestrogens) within the last 3 months.
- •Anyone with diagnosed psychiatric disorders including major depressive disorder with acute symptoms, Bipolar disorder, Generalized anxiety disorder with active symptoms, PTSD with frequent nightmares
- •Anyone with diagnosed neurogenitive diseases or chronic pain disorders including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia
- •Anyone who regularly consumes prescribed stimulant medications including Amphetamines (e.g., Adderall, Vyvanse), Methylphenidate (e.g., Ritalin, Concerta), and Modafinil / Armodafinil
- •Anyone currently on CNS activating anti-depressants including Bupropion (Wellbutrin), Fluoxetine, Venlafaxine (Effexor), Sertraline (Zoloft).
- •Current or recent use of cannabis or THC-containing products, including recreational or medicinal marijuana, CBD products with measurable THC content, or synthetic cannabinoids, within the past 30 days.
- •Anyone with a job that disrupts their nighttime sleep (e.g., excessive travel, night/3rd shift workers).
- •Anyone unwilling to wear the Oura ring device for the duration of the trial or unwilling to open the Oura application at least three times each week during the trial for data to sync to the cloud
- •Anyone currently taking a prescription sleep aid.
- •Anyone who introduces any new supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of the study.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •Anyone with a history of substance abuse.
- •Anyone who drinks heavily (i.e., 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- •Currently partaking in another research study or will be partaking in any other research study for the next 7 weeks, or at any point during this study's duration.
研究组 & 干预措施
Placebo
Placebo Comparator
Maltodextrin + Flavoring
干预措施: Placebo (Dietary Supplement)
Novel Sleep Supplement
Experimental
Novel powdered sleep supplement
干预措施: Novel powdered sleep supplement (Dietary Supplement)
结局指标
主要结局
Tracked sleep activity
时间窗: 42 days
Assessed via Oura ring
Sleep quality
时间窗: Baseline, week 3, and week 6
Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly
次要结局
- Dietary habits(Baseline and endpoint (week 6))
- Oura Actigraphy - Daytime Activity(42 days)
研究者
研究点 (1)
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