Phase
Condition
N/ATreatment
Proprietary Nutritional Supplement
Placebo Supplement
Clinical Study ID
Ages 45-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females, ≥45 to ≤65 years of age
BMI ≥18.5 and <30.0 kg/m2
Ambulatory and currently free of injury or other physical impairment that hindersmobility.
Willing to use personal smart phone with operating system (Android version 12.0 ornewer; iOS version 16 or newer).
Willingness to maintain current skin care regimen and avoid any skin-related medicalprocedures.
Willing to adhere to all study procedures, including lifestyle considerations andsign forms providing informed consent to participate in the study and authorizationto release relevant protected health information to the Clinical Investigator.
Exclusion
Exclusion Criteria:
Is currently following, or planning to be on, a weight loss regimen.
Weight loss or gain >4.5 kg.
History of gastrointestinal surgery for weight reducing purposes.
History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, bingeeating) at the discretion of the Clinical Investigator.
History of neurologic disorder that could produce cognitive deterioration.
History of bouts of delirium, confusion, repeated minor head injury or a singleinjury.
History of unconventional sleep patterns or a diagnosed sleep disorder.
History of any infective or inflammatory brain disease.
Use of tobacco/nicotine products.
Use of hemp/marijuana products.
Unstable use of any prescription medication.
Unstable use (initiation or change in dose) of hormonal contraceptives or therapy.
Use of any dietary supplements (orally or infused), other than a conventional oncedaily multi-vitamin.
Use of medication(s) or dietary supplement(s) known to affect absorption.
Recent history of or strong potential for alcohol or substance abuse.
Exposed to any non-registered drug product.
A score of <7 on the Vein Access Scale Assessment.
History or presence, on the basis of the medical history or screening labs, ofclinically important cardiac, renal, hepatic, endocrine (including diabetesmellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurologicaldisorders.
Uncontrolled hypertension.
Known allergy to any ingredients contained in the study product.
Any signs or symptoms of active infection of clinical relevance.
History or presence of cancer in the prior 2 years, except for non-melanoma skincancer.
History of any major trauma or major surgical event.
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.
An employee or representative who has a financial interest in Sponsor organization.
Study Design
Study Description
Connect with a study center
Biofortis Clinical Research
Addison 4882920, Illinois 4896861 60101
United StatesActive - Recruiting

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