Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:04 PM
Study NCT ID:
NCT07357818
Status:
RECRUITING
Last Update Posted:
2026-01-22
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Caffeinated Beverages on Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This interventional trial focuses on evaluating the effects of the intervention on health and well-being.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2025-12-26', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physiological responses - Heart rate', 'timeFrame': 'Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption', 'description': 'Data collected by wearables'}, {'measure': 'Subjective beverage experience ratings', 'timeFrame': 'After 5 days of daily consumption', 'description': 'Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.'}, {'measure': 'Physiological response - Sleep', 'timeFrame': 'Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption', 'description': 'Data collected by wearables'}, {'measure': 'Physiological responses - Activity', 'timeFrame': 'Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption', 'description': 'Data collected by wearables'}], 'primaryOutcomes': [{'measure': 'Subjective caffeine visual analog scales', 'timeFrame': 'After 5 days of daily consumption', 'description': 'Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.'}], 'secondaryOutcomes': [{'measure': 'Subjective caffeine visual analog scales', 'timeFrame': 'Up to 5 hours after beverage consumption', 'description': 'Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.'}, {'measure': 'Subjective quality of life ratings', 'timeFrame': 'After 5 days of daily consumption', 'description': 'Participants will rate how they feel using a Likert scale from 0-5. Where higher score indicate higher frequency in that feeling.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Caffeine beverages in health and well-being'], 'conditions': ['Healthy', 'Caffeine', 'Beverage Intake']}, 'descriptionModule': {'briefSummary': 'This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.', 'detailedDescription': "This will evaluate post-beverage subjective caffeine responses using visual analog scale questionnaires, mood, quality of life, and physiological responses to caffeine beverages compared to participants' habitual caffeine beverage intake in generally healthy adults."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females, ≥18 to ≤55 years of age\n2. BMI ≥18.5 and \\<29.9 kg/m2\n3. Generally good health\n4. Participant currently and consistently has a caffeine routine\n5. Participant is willing to substitute their current caffeine routine for the test beverage daily\n6. Participant has never consumed the test beverage or similar products\n7. Participant currently owns a wearable and is willing to use and connect the wearable device\n8. Willing to use personal smart phone, tablet, or personal computer with stable internet connection\n9. Willing and able to comply with all study procedures\n10. Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study\n\nExclusion Criteria:\n\n1. History or presence, on the basis of the health history, of clinically important condition or disease states\n2. Is currently following, or planning to be on, a weight loss regimen\n3. Weight loss or gain \\>4.5 kg\n4. History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions\n5. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.\n6. History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder\n7. Use of tobacco/nicotine products\n8. Use of hemp/marijuana products\n9. Unstable use of any prescription medication\n10. Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine\n11. Recent history of alcohol or substance abuse\n12. Exposed to any non-registered drug product\n13. Self-report of hypertension/high blood pressure without use of hypertensive medications\n14. Any known allergy or intolerance to any ingredients contained in the study product\n15. Any signs or symptoms of active infection of clinical relevance\n16. History or presence of cancer, except for non-melanoma skin cancer\n17. History of any major trauma or major surgical event\n18. Female who is pregnant, planning to be pregnant during the study period, lactating\n19. An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.\n20. Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol\n21. A clinically significant medical condition that is affected by caffeine"}, 'identificationModule': {'nctId': 'NCT07357818', 'briefTitle': 'Effects of Caffeinated Beverages on Well-being', 'organization': {'class': 'INDUSTRY', 'fullName': 'GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.'}, 'officialTitle': 'A Randomized, Decentralized, Crossover, Open-Label Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine', 'orgStudyIdInfo': {'id': 'NL-2502'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Test caffeinated beverage followed by participants' typical caffeinated beverage", 'interventionNames': ["Other: Participants' typical caffeinated beverage", 'Other: Test caffeinated beverage']}, {'type': 'OTHER', 'label': "Participants' typical caffeinated beverage followed by test caffeinated beverage", 'interventionNames': ["Other: Participants' typical caffeinated beverage", 'Other: Test caffeinated beverage']}], 'interventions': [{'name': "Participants' typical caffeinated beverage", 'type': 'OTHER', 'description': 'Participants will consume the caffeinated beverage they typically consume.', 'armGroupLabels': ["Participants' typical caffeinated beverage followed by test caffeinated beverage", "Test caffeinated beverage followed by participants' typical caffeinated beverage"]}, {'name': 'Test caffeinated beverage', 'type': 'OTHER', 'description': 'Participants will consume a test beverage that contains caffeine.', 'armGroupLabels': ["Participants' typical caffeinated beverage followed by test caffeinated beverage", "Test caffeinated beverage followed by participants' typical caffeinated beverage"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alethios, Inc.', 'role': 'CONTACT', 'email': 'support@alethios.com', 'phone': '650-206-8006'}], 'facility': 'Alethios, Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'VP Product Innovation, Guayaki Sustainable Rainforest Products', 'role': 'CONTACT', 'email': 'info@guayaki.com', 'phone': '609-799-6067'}, {'name': 'Alethios, Inc.', 'role': 'CONTACT', 'email': 'support@alethios.com', 'phone': '650-206-8006'}], 'overallOfficials': [{'name': 'Kristin Nieman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nlumn LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nlumn LLC', 'class': 'UNKNOWN'}, {'name': 'Alethios, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}