Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT04706494
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Efficacy of AlphaWave® L-Theanine on Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in salivary cortisol levels from pre- to post-tests between AlphaWave® LTheanine versus placebo.', 'timeFrame': '9 days', 'description': 'Assessed by analysis of saliva sample at baseline and end of study'}, {'measure': 'The change in EEG total alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.', 'timeFrame': '9 days', 'description': 'Measured and analyzed at baseline and end of study'}, {'measure': 'The change in EEG frontal alpha wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.', 'timeFrame': '9 days', 'description': 'Measured and analyzed at baseline and end of study'}, {'measure': 'The change in EEG midline theta wave readings from pre- to post-tests between AlphaWave® LTheanine versus placebo.', 'timeFrame': '9 days', 'description': 'Measured and analyzed at baseline and end of study'}], 'secondaryOutcomes': [{'measure': 'The change in heart rate from pre-to post-test between the investigational product versus placebo', 'timeFrame': '9 days', 'description': 'Measured at baseline and end of study'}, {'measure': 'The change in blood pressure from pre- to post-test between the investigational product versus placebo', 'timeFrame': '9 days', 'description': 'Measured at baseline and end of study'}, {'measure': 'The change in State-Trait Anxiety Inventory (STAI) from pre- to post-test between the investigational product versus placebo', 'timeFrame': '9 days', 'description': "Assessed by the participants' answers to the questionnaire"}, {'measure': 'The change in Visual Analog Scale (VAS) from pre- to post-tests between the investigational product versus placebo', 'timeFrame': '9 days', 'description': "Assessed by the participants' answers to the questionnaire"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'referencesModule': {'references': [{'pmid': '34562208', 'type': 'DERIVED', 'citation': 'Evans M, McDonald AC, Xiong L, Crowley DC, Guthrie N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave(R) L-Theanine on Stress in a Healthy Adult Population. Neurol Ther. 2021 Dec;10(2):1061-1078. doi: 10.1007/s40120-021-00284-x. Epub 2021 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'AlphaWave® L-theanine will be compared against placebo to evaluate how the investigational study product effects on salivary cortisol, EEG readings, blood pressure, and heart rate in a moderately stressed and otherwise healthy adult population. It is hypothesized that participants taking the AlphaWave® L-theanine will have reduced stress levels as assessed by the parameters stated. Participants will be consuming the investigational study product or placebo in the clinic only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females between 18 and 65 years of age, inclusive\n* BMI between 18.5 to 29.9 kg/m2, inclusive\n* Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal for at least 1 year prior to screening OR,\n* Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n\n * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)\n * Double-barrier method\n * Intrauterine devices\n * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n * Vasectomy of partner at least 6 months prior to screening\n* Individuals with moderate stress as determined by the Perceived Stress Scale (scores ranging from 14 - 26 are considered moderate stress)\n* Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 9 hours of sleep for at least 3 weeks prior to baseline\n* Agrees to maintain current sleep schedule throughout study\n* Agrees to maintain current levels of diet, supplements, and exercise until the end of the study\n* Agrees to refrain from exercising 24-hours prior to the visits\n* Agrees to abstain from using hair products on the day of visits\n* Willingness to complete questionnaires, records, diaries associated with the study, and to complete all clinic visits\n* Healthy as determined by medical history, laboratory results, and physical exam as assessed by the QI\n\nExclusion Criteria:\n\n* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial\n* Clinically significant abnormal laboratory results at screening as assessed by the QI\n* Participants who have a known allergy to the test material's active or inactive ingredients\n* Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks\n* Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel\n* Self reported epilepsy and/or seizures\n* Type I or Type II Diabetes\n* Unstable metabolic disease or chronic diseases as assessed by the QI\n* Current or history of any significant disease of the gastrointestinal tract\n* Hypertension treated with medication or supplements or untreated hypertension\n* Self reported anxiety or depression\n* Significant cardiovascular event in the past 6 months as assessed by the QI\n* Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI\n* Individuals with an autoimmune disease or are immune-compromised\n* History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months\n* Self reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\n* Self reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation\n* Self reported blood/bleeding disorders that will have an effect on safety outcomes as assessed by the QI\n* Alcohol or drug abuse within the last 12 months\n* High alcohol intake (\\>2 standard drinks per day)\n* Use of medicinal cannabinoid products\n* Chronic use of cannabinoid products (\\>2 times/week). Occasional use to be assessed by the QI on a case by case basis\n* Use of tobacco and nicotine-containing products within 60 days of baseline\n* Current use of prescribed medications listed: antibiotics, antiepileptics, antiseizure medications, sedatives, hypnotics\n* Current use of over-the-counter medications, supplements, foods, and/or drinks listed: caffeine, green tea, L-theanine supplements, melatonin supplements, valerian root supplements, GABA supplements, tart cherries/drinks/supplements, amla, ashwagandha, rhodiola, shatavari, ginseng\n* Blood donation 30 days prior to screening or a planned donation 30-days of the last study visit\n* Participants in a clinical research trial within 30 days of screening\n* Individuals who are unable to give informed consent\n* Any other condition that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant"}, 'identificationModule': {'nctId': 'NCT04706494', 'briefTitle': 'A Study to Investigate the Efficacy of AlphaWave® L-Theanine on Stress', 'organization': {'class': 'OTHER', 'fullName': 'Ethical Naturals, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Investigate the Efficacy of an Acute Dose of AlphaWave® LTheanine on Stress in a Healthy Adult Population', 'orgStudyIdInfo': {'id': '19LSHE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AlphaWave® LTheanine', 'interventionNames': ['Dietary Supplement: AlphaWave® LTheanine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'AlphaWave® LTheanine', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 mg of AlphaWave® LTheanine', 'armGroupLabels': ['AlphaWave® LTheanine']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'microcrystalline cellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5R8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KGK Science Inc.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Mal Evans, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'KGK Science Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethical Naturals, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}