[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07076537":3,"trial-entities:NCT07076537":77,"trial-summary:NCT07076537":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":49,"minimum_age":50,"maximum_age":51,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":57,"locations":59,"central_contacts":73,"overall_officials":74,"references":75,"see_also_links":76},"NCT07076537","ULOLLYKC2","A Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population","A Randomized Placebo Controlled Clinical Study on the Effects of a Dietary Supplement on Stress, Anxiety, Mood and Sleep in a Pediatric Population","NOT_YET_RECRUITING","2025-09-02","2025-07","2025-07-22","2025-07-15","Olly, PBC","INDUSTRY",false,"The study will be a randomized, placebo control clinical study to assess the the efficacy for improvement of mood\u002Fstress and anxiety compared to placebo through validated survey questionnaire. The target population of this study is 5 to 14 years old. Participants will be asked to take questionnaires to collect baseline at the beginning of the study. The questionnaires are: Perceived Stress Scale for children (PSS-ch), The Positive Affect and Negative Affect Schedule-Child Form-children (PANAS-children) and the Children's Sleep Habits Questionnaire (CSHQ). The interventional treatment will be for a total of 4 weeks (28 days). Participants will be asked to take the questionnaires at the end of the 28 days. The subjects will attend two appointments in the clinic throughout the duration of the study.","For these scale, here are some more details:\n\nThe PSS-C:\n\nScoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.\n\nInterpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.\n\nThe PANAS-C:\n\nScoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:\n\n* Positive Affect (PA): 15 to 75\n* Negative Affect (NA): 15 to 75\n\nInterpretation:\n\nHigher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)\n\nThe CSHQ Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.\n\nInterpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.",[19],"Healthy",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},80,"ESTIMATED",[29,33],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DIETARY_SUPPLEMENT","Placebo",[31],{"type":30,"name":34,"description":35,"armGroupLabels":36},"Dietary Supplement with actives","Dietary Supplement containing magnesium, L-theanine and lemon balm extract",[34],[38],{"measure":39,"description":40,"timeFrame":41},"To assess the efficacy for improvement of feelings of stress compared to placebo through validated survey questionnaire.","PSS-children will be administered before the intervention to establish baseline, 40 min after taking the initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement in stress levels across the active and placebo arms. Data will be compared between the active supplement and placebo groups.\n\nMore details on the scales\n\nThe PSS-C: (perceived stress scale -children form) Scoring range: Each item is scored from 0 (Never) to 4 (Very Often), giving a total score range from 0 to 56.\n\nInterpretation: Higher scores indicate higher perceived stress, meaning a worse outcome.","from enrollment to end of study at Week 4",[43,46],{"measure":44,"description":45,"timeFrame":41},"To assess the efficacy for improvement of feelings of positive and negative mood, and anxiety compared to placebo through validated survey questionnaire.","PANAS-children questionnaire will be administered before the intervention, to establish baseline, 40 min after initial dose and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement of positive and negative mood across the active and placebo arms. Data will be compared between the active supplement and placebo groups.\n\nMore details on scale:\n\nThe PANAS-C: (positive and negative affect scale-children form)\n\nScoring range: Each item is rated on a scale from 1 (Very slightly or not at all) to 5 (Extremely), resulting in:\n\n* Positive Affect (PA): 15 to 75\n* Negative Affect (NA): 15 to 75\n\nInterpretation:\n\nHigher PA scores indicate more positive emotions (a better outcome) Higher NA scores indicate more negative emotions (a worse outcome)",{"measure":47,"description":48,"timeFrame":41},"To assess the efficacy for improvement of sleep quality compared to placebo through validated survey questionnaire.","CSHQ questionnaire will be administered before the intervention, to establish baseline, and after taking the product for 28 days consecutively. Scores will be analyzed to assess changes in improvement sleep quality across the active and placebo arms. Data will be compared between the active supplement and placebo groups.\n\nMore details on scale:\n\nThe CSHQ (children sleep habits questionnaire) Scoring range: Each item is scored as follows - 1 (Rarely), 2 (Sometimes), 3 (Usually). This gives a total score range from 33 to 99.\n\nInterpretation: Higher scores suggest more disturbed or problematic sleep patterns, meaning a worse outcome.","ALL","5 Years","14 Years",true,{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion Criteria:\n\n1. Willingness to actively participate in the study and to come to the scheduled visits.\n2. Healthy (Healthy as determined by medical history as assessed by Qualified Investigator ) female and male subjects in good health between 5 to 14 years old.\n3. Enrolled in and currently attending school at baseline and for the duration of the study period.\n4. Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.\n5. Ability to give consent (assent) for participation in the study\n\nExclusion Criteria:\n\n1. Diagnosed with any mental health condition including chronic stress, GAD, impaired cerebral function, mood disorders, ADHD or similar conditions\n2. Currently taking any prescription medications or dietary supplements for sleep, anxiety, depression or ADHD\n3. Liver dysfunction\n4. Use of sleep aides including dietary supplements over the past 7 days\n5. History of reaction to the category of product tested\n6. Other diseases or medications that might directly interfere in the study or put the subject's health under risk.\n7. Participants having an acute or chronic disease or medical condition could put him\u002Fher at risk in the opinion of the Principal Investigator or compromise study outcomes.\n8. Typical uncontrolled chronic or serious disease and\u002For conditions which would prevent participation in any clinical trials such as cancer, AIDs, diabetes, renal- impairment, mental illness, drug\u002Falcohol addiction.\n9. Subjects with a history of cancer within the past 5 years.\n10. Subjects with any planned surgeries and\u002For invasive medical procedures during the study.\n11. Individuals unable to communicate or cooperate with the principal investigator due to language\n12. Employees (and children of employees) of TKL and\u002For product brand owner or manufacturer.",[58],"CHILD",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":70},"TKL Research","Fair Lawn","New Jersey","07410","United States",[67],{"name":68,"role":69},"John Lyssikatos","CONTACT",{"lat":71,"lon":72},40.94038,-74.13181,[],[],[],[],{"nct_id":4,"conditions":78,"biomarkers":79},[19],[],{"nct_id":4,"found":52,"summary":81,"prompt_version":91},{"design":82,"status":83,"heading":84,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is a randomized, placebo-controlled study, meaning participants will be randomly assigned to receive either the dietary supplement or a placebo. It plans to include 80 participants.","completed","Study on a Dietary Supplement for Stress, Anxiety, Mood, and Sleep in Children","This study is looking at how a dietary supplement containing magnesium, L-theanine, and lemon balm extract might affect stress, anxiety, mood, and sleep in children aged 5 to 14 years old. Participants will either receive this dietary supplement or a placebo (an inactive substance that looks like the supplement). The main goal is to see if the supplement can improve feelings of stress compared to the placebo, using surveys. Researchers will also use questionnaires to measure changes in positive and negative emotions, and sleep habits. The study is looking for 80 healthy children who are currently attending school.","Participants will be assessed at the end of the 4-week study period.",98,"Participants will take questionnaires at the beginning of the study and again after 4 weeks (28 days) of taking either the dietary supplement or placebo.","Not stated in the trial record.",[31],"v2"]