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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
422
Pills of cognitive nutritional supplement
Matching placebo to active
Biofortis Innovation Services
Addison, Illinois, United States
RECRUITINGFeature 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 12
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 12
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 12
Double Trouble
Overall Score: The number of correctly answered problems, minus incorrect ones
Time frame: Week 0, Week 6, and Week 12
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 12
Token Search
Average Score (number of boxes): Average number of boxes in which all tokens were located without error
Time frame: Week 0, Week 6, and Week 12
Rotations
Overall Score: The sum of the difficulties of all successfully answered problems, minus the sum of the difficulties of all incorrectly answered problems
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 0, Week 6, and Week 12
Number Ladder
Maximum Level Completed: The hardest level (i.e., the problem with the highest number of targets) that the individual successfully completed
Time frame: Week 0, Week 6, and Week 12
Paired Associates
Maximum Level Completed: The hardest level (i.e., the problem with the highest number of targets) that the individual successfully completed
Time frame: Week 0, Week 6, and Week 12
Odd One Out
Overall Score: The number of correctly answered problems, minus incorrect ones
Time frame: Week 0, Week 6, and Week 12
Polygons
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 12
Grammatical Reasoning
Overall Score: The number of correctly answered problems, minus incorrect ones
Time frame: Week 0, Week 6, and Week 12
Digit Span
Overall Score: The highest number completed
Time frame: Week 0, Week 6, and Week 12
Spatial Spanning
Overall Score: (The minimum number of moves required to solve the puzzle \* 2) - (the number of moves actually made)
Time frame: Week 0, Week 6, and Week 12
THAT
Alertness rating (Sum of individual Likert scale scores)
Time frame: Week 0, Week 6, and Week 12
Food Frequency Questionnaire: Total Kcal/Day
Healthy Eating Index (HEI)-2020: Total kcal/d
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total carbohydrate (g/d)
Healthy Eating Index (HEI)-2020: Total carbohydrate (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total fiber (g/d)
Healthy Eating Index (HEI)-2020: Total fiber (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total fat (g/d)
Healthy Eating Index (HEI)-2020: Total fat (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total protein (g/d)
Healthy Eating Index (HEI)-2020: Total protein (g/d)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total intake of other essential nutrient (mg/d)
Healthy Eating Index (HEI)-2020: Total intake of other certain essential nutrient (mg/day)
Time frame: Week 0 and Week 12
Food Frequency Questionnaire: Total caffeine (mg/day)
Healthy Eating Index (HEI)-2020: Total caffeine (mg/day)
Time frame: Week 0 and Week 12