The Effects of a Nutritional Supplement on Sleep Quality

Обзор

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.

Вмешательства

• Пищевая добавка Novel powdered sleep supplement
  A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients
• Пищевая добавка Placebo
  maltodextrin placebo

Первичные конечные точки

• Tracked sleep activity [Срок оценки: 42 days]
• Sleep quality [Срок оценки: Baseline, week 3, and week 6]

Вторичные конечные точки (2)

• Dietary habits [Срок оценки: Baseline and endpoint (week 6)]
• Oura Actigraphy - Daytime Activity [Срок оценки: 42 days]

Критерии участия

Критерии включения

• Be male or female
• Be aged 35-65.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Citruslabs — Santa Monica

Идентификаторы

NCT: NCT07345260 · AG-20801

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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