Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:51 AM
Study NCT ID:
NCT07311434
Status:
RECRUITING
Last Update Posted:
2026-02-11
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Morning Wellbeing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'Days 7, 14, and 30', 'description': 'Assessed by subjective questionnaire'}, {'measure': 'Daytime Sleepiness', 'timeFrame': 'Days 1, 7, 14, and 30', 'description': 'Assessed by subjective questionnaire'}], 'primaryOutcomes': [{'measure': 'Evening relaxation, sleep quality, and morning vitality', 'timeFrame': 'Days 1, 3, 7, 14, 30', 'description': 'Assessed by subjective questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Relaxation', 'Stress', 'Daytime Sleepiness']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female.\n* Age 25-59 years.\n* BMI ≥18.5 and ≤29.9 kg/m².\n* Currently experiencing issues with sleep quality, falling asleep, staying asleep, or waking during the night.\n* RU-SATED score ≤17.\n* Willing and able to follow the study protocol.\n* 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.\n* Agree to limit alcohol intake within approximately 4 hours of bedtime throughout participation.\n* 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.\n* Generally healthy and not living with any uncontrolled chronic disease.\n* Resides in the United States.\n* Willing to discontinue any restricted products and adhere to all required study assessments.\n\nExclusion Criteria:\n\n* Diagnosed chronic sleep conditions (e.g., insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, sleep apnea).\n* Current use of sleep-tracking technology (e.g., wrist-worn trackers, rings, smartphone apps) that could influence sleep behavior or perception.\n\nWomen currently undergoing perimenopause or experiencing vasomotor symptoms (e.g., night sweats).\n\n* Use of hormone therapy (estrogen, progesterone, phytoestrogens) within the last 3 months.\n* Diagnosed psychiatric disorders including major depressive disorder with acute symptoms, bipolar disorder, generalized anxiety disorder with active symptoms, and PTSD with frequent nightmares.\n* Diagnosed neurodegenerative or chronic pain disorders, including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.\n* Regular prescribed stimulant use (e.g., amphetamines such as Adderall/Vyvanse; methylphenidate such as Ritalin/Concerta; modafinil/armodafinil).\n* Current use of CNS-activating antidepressants (bupropion, fluoxetine, venlafaxine, sertraline).\n* 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.\n* Employment in jobs disrupting nighttime sleep (e.g., night shift, rotating shift, excessive travel).\n* Current use of prescription sleep aids.\n* Introduction of any new sleep-related supplements, medications, herbal remedies, or melatonin products during the study.\n* 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.\n* Allergy or sensitivity to any study product ingredients.\n* Pregnant, breastfeeding, or trying to conceive during the study period.\n* History of substance abuse.\n* Heavy alcohol use (≥8 drinks/week for women or ≥15 drinks/week for men).\n* Participation in another research study now or within the next 7 weeks.\n* Any condition or behavior that, in the investigator's judgment, may interfere with study participation or data integrity."}, 'identificationModule': {'nctId': 'NCT07311434', 'briefTitle': 'Sleep and Morning Wellbeing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Athletic Greens International'}, 'officialTitle': 'Evaluation of Perceived Outcomes With AGZ: A Randomized, Controlled, Consumer Perception Study', 'orgStudyIdInfo': {'id': 'AGZ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Supplement', 'description': 'Sleep Supplement', 'interventionNames': ['Dietary Supplement: Sleep Supplement']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Diet', 'description': 'Usual Diet'}], 'interventions': [{'name': 'Sleep Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powdered sleep supplement', 'armGroupLabels': ['Sleep Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zeenia Framroze', 'role': 'CONTACT', 'email': 'support@alethios.com', 'phone': '6502068006'}], 'facility': 'Alethios (Virtual Study Platform)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Philip Sapp, PhD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athletic Greens - AG1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Athletic Greens International', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}