[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07428889":3,"trial-entities:NCT07428889":99,"trial-summary:NCT07428889":102},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":46,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":79,"locations":82,"central_contacts":92,"overall_officials":93,"references":97,"see_also_links":98},"NCT07428889","BIO-2601","Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement","A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults","COMPLETED","2026-04-05","2026-08","2026-08-06","2026-02-17","Shaklee Corporation","INDUSTRY",false,"The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.","The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+), its metabolites, and markers of health in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.",[19],"Healthy Adult",[21,22],"NAD+ metabolism","Markers of health","INTERVENTIONAL","OTHER",[26],"NA",{"count":28,"type":29},29,"ACTUAL",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIETARY_SUPPLEMENT","Proprietary Nutritional Supplement","1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days",[36],"Proprietary nutritional supplement",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Placebo Supplement","1000 mg maltodextrin, taken orally, daily for 60 days",[41],"Placebo supplement",[43],{"measure":44,"timeFrame":45},"Nicotinamide adenine dinucleotide response in whole blood","Baseline to Day 14",[47,50,54,57,59,61,65,68],{"measure":48,"timeFrame":49},"Nicotinamide adenine dinucleotide metabolite responses","Baseline to Days 1, 7, 14, and 30",{"measure":51,"description":52,"timeFrame":53},"Subjective cognitive function visual analog scales","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.","Baseline to Days 30 and 60",{"measure":55,"description":56,"timeFrame":53},"Subjective quality of life questionnaire","Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.",{"measure":58,"timeFrame":53},"Metabolic health markers",{"measure":60,"timeFrame":53},"Biological age",{"measure":62,"description":63,"timeFrame":64},"Cardiorespiratory fitness","Predicted VO2 max","Baseline to Day 30 and 60",{"measure":66,"description":67,"timeFrame":53},"Physical function","6 minute-walk test",{"measure":69,"description":56,"timeFrame":70},"Subjective skin assessment questionnaire","Days 30 and 60","ALL","45 Years","65 Years",true,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"Inclusion Criteria:\n\n1. Males and females, ≥45 to ≤65 years of age\n2. BMI ≥18.5 and \\\u003C30.0 kg\u002Fm2\n3. Ambulatory and currently free of injury or other physical impairment that hinders mobility.\n4. Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer).\n5. Willingness to maintain current skin care regimen and avoid any skin-related medical procedures.\n6. Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.\n\nExclusion Criteria:\n\n1. Is currently following, or planning to be on, a weight loss regimen.\n2. Weight loss or gain \\>4.5 kg.\n3. History of gastrointestinal surgery for weight reducing purposes.\n4. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.\n5. History of neurologic disorder that could produce cognitive deterioration.\n6. History of bouts of delirium, confusion, repeated minor head injury or a single injury.\n7. History of unconventional sleep patterns or a diagnosed sleep disorder.\n8. History of any infective or inflammatory brain disease.\n9. Use of tobacco\u002Fnicotine products.\n10. Use of hemp\u002Fmarijuana products.\n11. Unstable use of any prescription medication.\n12. Unstable use (initiation or change in dose) of hormonal contraceptives or therapy.\n13. Use of any dietary supplements (orally or infused), other than a conventional once daily multi-vitamin.\n14. Use of medication(s) or dietary supplement(s) known to affect absorption.\n15. Recent history of or strong potential for alcohol or substance abuse.\n16. Exposed to any non-registered drug product.\n17. A score of \\\u003C7 on the Vein Access Scale Assessment.\n18. History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders.\n19. Uncontrolled hypertension.\n20. Known allergy to any ingredients contained in the study product.\n21. Any signs or symptoms of active infection of clinical relevance.\n22. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.\n23. History of any major trauma or major surgical event.\n24. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use of sex hormones for contraception.\n25. An employee or representative who has a financial interest in Sponsor organization.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Biofortis Clinical Research","Addison","Illinois","60101","United States",{"lat":90,"lon":91},41.9317,-87.98896,[],[94],{"name":95,"affiliation":13,"role":96},"Erin Barrett, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[19],[],{"nct_id":4,"found":74,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This study is an interventional study, meaning participants will receive a specific treatment. It involves 34 participants who will be randomly assigned to receive either the active supplement or a placebo.","completed","Nutritional Supplement Study for Healthy Adults","This study is looking at how a special nutritional supplement affects nicotinamide adenine dinucleotide (NAD+) levels in healthy adults. NAD+ is a molecule important for energy and cell health. You would take either the \"Proprietary Nutritional Supplement\" (1000 mg of nicotinamide metabolites and plant extracts) or a \"Placebo Supplement\" (1000 mg of maltodextrin, an inactive substance) every day for 60 days. Researchers will measure your NAD+ levels in your blood to see if the supplement makes a difference. They are particularly interested in changes from the beginning of the study to day 14. This study is for healthy adults between 45 and 65 years old. The study is currently unclear on its recruitment status and plans to enroll 34 people.","Researchers will measure your NAD+ levels up to day 14 after starting the supplement.",120,"You would take a supplement by mouth daily for 60 days. Your NAD+ levels in whole blood will be measured at the start of the study and again at day 14.","Not stated in the trial record.",[33,38],"v2"]