Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 12:50 PM
Study NCT ID:
NCT05857956
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2023-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-04', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Attention-deficit/hyperactivity disorder (ADHD)-like symptoms. [Time Frame: Baseline to Day 28]', 'timeFrame': '28 days', 'description': 'Survey-based assessment (0-5) scale of changes in symptoms associated with ADHD. Parameters explored include focus \\& concentration, productivity, mood, and "brain fog".'}], 'secondaryOutcomes': [{'measure': 'Assess the product as a replacement for coffee or caffeinated beverages. [Time Frame: Baseline to Day 28]', 'timeFrame': '28 days', 'description': 'Survey-based assessment regarding changes in daily coffee/beverage consumption, stress, anxiety, jitters, energy crash, and gastrointestinal upset. Responses will be statistically analyzed and reported as % of subject responses.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD', 'Attention Difficulties', 'Mood', 'Anxiety', 'Caffeine']}, 'descriptionModule': {'briefSummary': 'This is a virtual, single-arm clinical trial that will last 28 days. Participants will drink 1 bottle of Proper Wild energy shot daily and complete questionnaires at baseline, day 1, day 14, and day 28.\n\nAttention deficit hyperactivity disorder (ADHD)-like symptoms, such as concentration, focus, and attention, will be evaluated at baseline and at each check-in. Likert scale responses will be examined from baseline to each check-in. Participant responses on product feedback will be presented as % scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently experiencing symptoms associated with ADHD, including:\n\nImpulsiveness. Disorganization and problems prioritizing Poor time management skills Problems focusing on a task Trouble multitasking Excessive activity or restlessness Poor planning\n\n* Age 18-55\n* Self-reported issues with focus and/or productivity\n* Generally healthy - don't live with any uncontrolled chronic disease\n\nExclusion Criteria:\n\n* Currently taking prescription medication for ADHD\n* Currently supplementing with L-Theanine.\n* Known to respond negatively to caffeine (no effect, makes them sleepy or feel unwell)\n* People with a high caffeine tolerance defined as regular consumption of \\>400mg of caffeine (\\>4 coffees) per day.\n* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.\n* Anyone with known severe allergic reactions.\n* Women who are pregnant, breastfeeding, or attempting to become pregnant\n* Unwilling to follow the study protocol."}, 'identificationModule': {'nctId': 'NCT05857956', 'briefTitle': 'A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Proper Wild, Inc.'}, 'officialTitle': 'A Clinical Trial to Assess the Efficacy of a Plant-based Energy Shot on Focus and ADHD-like Symptoms', 'orgStudyIdInfo': {'id': '20290'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proper Wild energy shot', 'description': 'Participants will take one bottle daily of Proper Wild Energy shot in the morning. Participants will be advised to drink one bottle in the morning, with or without a meal, depending on their preference, as a replacement for their usual first caffeinated beverage of the day.', 'interventionNames': ['Other: Proper Wild energy shot']}], 'interventions': [{'name': 'Proper Wild energy shot', 'type': 'OTHER', 'description': '100% plant-based energy shot containing natural caffeine, L-Theanine, purified water, pineapple juice concentrate, natural flavors, kiwi juice concentrate, organic lemon juice concentrate, organic strawberry juice concentrate, monk fruit juice concentrate, pink himalayan sea salt.', 'armGroupLabels': ['Proper Wild energy shot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proper Wild, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}