A Clinical Trial to Assess Cognitive Effects of Cognitive Nutritional Supplement in General Population

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorPharmavite LLC

About this trial

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/focus related domains, compared to a placebo control, in a general population of adult men and women in the United States.

Eligibility criteria

Qualifiers

Male or female, ≥25 to ≤65 years of age at screening.

English is the primary spoken language.

Able to operate a study-provided iPad connected to the internet with a strong and reliable internet connection.

Willing to consume 3 capsules per day for 12 weeks.

Disqualifiers

Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, or any brain lesions including tumors.

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.

Any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.

Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.

Trial design

Treatments tested in this trial

  • Cognitive Nutritional Supplement
  • Placebo

Treatment groups

422 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Pharmavite LLC

Lead sponsor

Balchem Corporation

Collaborator

Biofortis Innovation Services

Collaborator