- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07311434
Sömn och Morgonvälbefinnandestudie
Utvärdering av upplevda resultat med AGZ: En randomiserad, kontrollerad konsumentuppfattningsstudie
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94117
- Alethios (Virtual Study Platform)
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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 ≤17.
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Sleep Supplement
Sleep Supplement |
Powdered sleep supplement |
|
Inget ingripande: Usual Diet
Usual Diet |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evening relaxation, sleep quality, and morning vitality
Tidsram: Days 1, 3, 7, 14, 30
|
Assessed by subjective questionnaire |
Days 1, 3, 7, 14, 30
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Sleep quality
Tidsram: Days 7, 14, and 30
|
Assessed by subjective questionnaire |
Days 7, 14, and 30
|
|
Daytime Sleepiness
Tidsram: Days 1, 7, 14, and 30
|
Assessed by subjective questionnaire |
Days 1, 7, 14, and 30
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Philip Sapp, PhD, MS, Athletic Greens - AG1
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AGZ001
Läkemedels- och apparatinformation, studiedokument
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