[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pharmavite LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100580434","a-clinical-trial-to-assess-cognitive-effects-of-cognitive-nutritional-supplement-in-general-population-100580434",false,"NCT06837246","A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population","A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Cognitive Effects of Cognitive Nutritional Supplementation in the General Population","Inclusion Criteria:\n\n1. Male or female, ≥25 to ≤65 years of age at screening.\n2. English is the primary spoken language.\n3. Able to operate a study-provided iPad connected to the internet with a strong and reliable internet connection.\n4. Willing to consume 3 capsules per day for 12 weeks.\n5. Willing to review and follow all training materials provided.\n6. Willing to avoid alcohol, marijuana\u002Fhemp products (including CBD products), and vigorous physical activity 24 h prior to the baseline (week 0), mid-point (Week 6), and end of study (Week 12) cognition testing days.\n7. Non-user or former user (cessation ≥12 months of screening) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco, nicotine gums or lozenges) with no plans to begin use during the study period.\n8. Willing to maintain habitual diet and physical activity patterns throughout the study.\n9. Willing to refrain from exclusionary medications, supplements, and products throughout the study.\n10. Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.\n\nExclusion Criteria:\n\nCognition related criteria\n\n1. Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, or any brain lesions including tumors.\n2. Diagnosed mental health disorder, such as major depressive disorder or any anxiety disorder. The use of daily or as-needed prescription medications to treat these conditions is also exclusionary.\n3. Any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.\n4. Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.\n5. Color blindness or visual impairments that cannot be corrected with glasses or contact lenses.\n6. Diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift of overnight workers).\n7. History of repeated head injury (e.g., concussions from sports activities) or single trauma resulting in a period of unconsciousness lasting 1 h or more.\n8. Diagnosis of a learning and\u002For behavioral disorders such as dyslexia.\n9. Diagnosis of attention-deficit\u002Fhyperactivity disorder (ADHD).\n10. Use of any dietary supplements, other than a conventional once-daily multivitamin\u002Fmineral supplement that does not contain certain nutrient with cognitive effects, during the study period. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.\n11. Experienced a major life stress event, including the death of a loved one, marriage or divorce, birth of a child, unemployment, or moved to a new residence, within the last 6 months.\n\n    General health related criteria\n12. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.\n13. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.\n\n    General safety related criteria\n14. Exposure to any non-registered drug product or has participated in another intervention study within 30 days prior to screening.\n15. Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as \\>14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).\n16. Another household member is a current participant in this study.\n17. Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.\n\n6.2.1 Excluded Products\n\n* Tobacco \u002F nicotine products within 12 months of screening and throughout the study period\n* Any non-registered drug product within 30 days of screening\n* Alcohol within 24 h of each cognition test day\n* Marijuana\u002Fhemp products (including CBD products) within 24 h of each cognition test day\n* Current use of any medication used to treat mental health disorders, such as major depressive disorder or any anxiety disorder\n* Current use of any medications used to treat ADHD\n* Current use of any dietary supplements, other than a conventional once-daily multivitamin\u002Fmineral supplement that does not contain certain nutrient with cognitive effect. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.",true,"ALL","25 Years","65 Years",{"count":21,"type":22},422,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a double-blind, randomized, 12-week parallel study that aims to determine the effects of a cognitive nutritional supplement for 12 weeks on cognition parameters specific to attention\u002Ffocus related domains, compared to a placebo control, in a general population of adult men and women in the United States.",[28,29,30,31],"Cognition","Concentration","Attention","Focus",[33,34,35,36,37,38,39,40,41],"cognition","concentration","attention","problem-solving","capsule","clinical trial","placebo-controlled","focus","memory","RECRUITING","2025-04-10",{"date":45,"type":46},"2025-04-15","ACTUAL",{"date":48,"type":46},"2025-02-24",{"date":50,"type":22},"2025-09-30",{"name":52,"class":53},"Pharmavite LLC","INDUSTRY",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":54},"100563057","effect-of-a-nutritional-supplement-on-gut-microbiota-in-adults-100563057","NCT06611215","Effect of a Nutritional Supplement on Gut Microbiota in Adults","A Randomized, Double Blind, Placebo-controlled, Parallel Study to Investigate the Effect of Prebiotic Supplements on Gut Microbiota Modulation and Quality of Life.","Inclusion Criteria:\n\nTo be eligible for inclusion, the Participant must fulfil all the following criteria:\n\n1. Be able to give written informed consent.\n2. Be between 18-60 years inclusive.\n3. BMI between 18.5 - 29.9kg\u002Fm2\n4. Is in general good health, as determined by the investigator.\n5. Consume less than 18g fiber per day.\n6. Maintain current dietary habits and physical activity levels.\n7. Willing to consume the Study Product for the duration of the study.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if they meet any of the following criteria:\n\n1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and\u002For currently breastfeeding.\n2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: a. Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).\n\n   b. Has a male sexual partner who is surgically sterilized prior to the Screening Visit and is the only male sexual partner for that Participant.\n\n   c. Sexual partner(s) is\u002Fare exclusively female. d. Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.\n\n   e. Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.\n3. Participants who are on anxiolytics, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and\u002For prescribed sleep medication at the time of screening.\n4. Participants with a current or history of drug (including illicit drug) and \u002For alcohol abuse at the time of enrolment.\n5. Change in medications or supplements, or major dietary changes within 90 days of visit 1, or planning to do so during the study. This includes planning to start any new medications, herbals, or supplements.\n6. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history including but not limited to:\n\n   1. Immunocompromised individuals (HIV\u002FAIDS, chemo\u002Fradiation)\n   2. Significant psychiatric disease (bipolar, schizophrenia, severe depression. Mild to Moderate depression stable on low dose medications \\>3 months may be considered eligible in the opinion of the investigator).\n7. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications including but not limited to:\n\n   1. Anti-infectives (including antibiotics\u002Fantifungals. HIV prophylaxis is acceptable) within the 90 days prior visit 1 and for the duration of study.\n   2. Steroids (inhaled, oral, or injected. Topical PRN use is acceptable) within the 28 days prior to visit 1 and for duration of study.\n   3. Antipsychotic, Anxiolytics, hypnotics.\n   4. Anticonvulsants.\n   5. Prescribed sleeping medications\n   6. Anti-rejection Medications\n   7. Opioid pain relievers\n8. Current or recent use of prohibited foods and nutritional or non-nutritional supplements, including:\n\n   a. Probiotics, Prebiotics, Post biotics and other fermented foods within the 28 days prior to visit 1. (Yogurt, kefir, kombucha) and for the duration of the study.\n9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.\n10. Participants may not be receiving treatment involving experimental drugs\u002Fsupplements. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.","18 Years","60 Years",{"count":65,"type":22},80,[25],"According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers\u002F Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.",[69,70],"Changes in Gut Microbiota with Prebiotic Supplementation","Quality of Life",[72,73,74],"microbiome","dietary supplement","prebiotic","NOT_YET_RECRUITING","2024-09-20",{"date":78,"type":46},"2024-09-24",{"date":80,"type":22},"2024-09-23",{"date":82,"type":22},"2025-06-02",{"name":52,"class":53},""]