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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cognitive Nutritional Supplement
Dietary supplementPills of cognitive nutritional supplement
Placebo
Other interventionMatching placebo to active
Treatment groups
422 Participants
are divided into 2 treatment groupsGroup A: Cognitive Nutritional SupplementPlacebo comparator 1 intervention
Group B: PlaceboActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feature Match
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
Time frame
Week 0, Week 6, and Week 12Secondary outcomes
1
Feature Match
Overall Reaction Time (ms): The average time taken to respond correctly Total Number of Errors: Sum of incorrect responses
Time frame
Week 0, Week 6, and Week 122
SART Test
Total Number of Errors: Sum of all commission errors (total count of inappropriate responses to a non-target stimulus \[the number 3\] and all omission errors (total number of times the participant failed to respond to a target stimulus \[any number other than 3\]
Time frame
Week 0, Week 6, and Week 123
Double Trouble
Overall Score: The number of correctly answered problems, minus incorrect ones
Time frame
Week 0, Week 6, and Week 124
Spatial Span
Overall Score (points): Total number of points scored during the task (points are awarded to each correctly solved puzzle, with more points awarded for more difficult puzzles)
Time frame
Week 0, Week 6, and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov