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| Name | Class |
|---|---|
| Balchem Corporation | INDUSTRY |
| Biofortis Innovation Services | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Nutritional Supplement | Placebo Comparator | Intervention is pills of cognitive nutrient |
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| Placebo | Active Comparator | Intervention is pills of matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Nutritional Supplement | Dietary Supplement | Pills of cognitive nutritional supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 0, Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Feature Match | Overall Reaction Time (ms): The average time taken to respond correctly Total Number of Errors: Sum of incorrect responses | 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] |
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Inclusion Criteria:
Exclusion Criteria:
Cognition related criteria
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.
Color blindness or visual impairments that cannot be corrected with glasses or contact lenses.
Diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift of overnight workers).
History of repeated head injury (e.g., concussions from sports activities) or single trauma resulting in a period of unconsciousness lasting 1 h or more.
Diagnosis of a learning and/or behavioral disorders such as dyslexia.
Diagnosis of attention-deficit/hyperactivity disorder (ADHD).
Use of any dietary supplements, other than a conventional once-daily multivitamin/mineral supplement that does not contain certain nutrient with cognitive effects, during the study period. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.
Experienced a major life stress event, including the death of a loved one, marriage or divorce, birth of a child, unemployment, or moved to a new residence, within the last 6 months.
General health related criteria
History or presence of cancer in the prior two years, except for non-melanoma skin cancer.
Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
General safety related criteria
Exposure to any non-registered drug product or has participated in another intervention study within 30 days prior to screening.
Recent history (within 12 months of visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz. beer, 5 oz. wine, or 1½ oz. distilled spirits).
Another household member is a current participant in this study.
Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
6.2.1 Excluded Products
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A Antoo, MD | Contact | 6306172000 | elizabeth.antoo@mxns.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services | Recruiting | Addison | Illinois | 60101 | United States |
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| Placebo | Other | Matching placebo to active |
|
| Week 0, Week 6, and Week 12 |
| Double Trouble | Overall Score: The number of correctly answered problems, minus incorrect ones | 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) | 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 | 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 | 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 | 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 | Week 0, Week 6, and Week 12 |
| Odd One Out | Overall Score: The number of correctly answered problems, minus incorrect ones | 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 | Week 0, Week 6, and Week 12 |
| Grammatical Reasoning | Overall Score: The number of correctly answered problems, minus incorrect ones | Week 0, Week 6, and Week 12 |
| Digit Span | Overall Score: The highest number completed | 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) | Week 0, Week 6, and Week 12 |
| THAT | Alertness rating (Sum of individual Likert scale scores) | Week 0, Week 6, and Week 12 |
| Food Frequency Questionnaire: Total Kcal/Day | Healthy Eating Index (HEI)-2020: Total kcal/d | Week 0 and Week 12 |
| Food Frequency Questionnaire: Total carbohydrate (g/d) | Healthy Eating Index (HEI)-2020: Total carbohydrate (g/d) | Week 0 and Week 12 |
| Food Frequency Questionnaire: Total fiber (g/d) | Healthy Eating Index (HEI)-2020: Total fiber (g/d) | Week 0 and Week 12 |
| Food Frequency Questionnaire: Total fat (g/d) | Healthy Eating Index (HEI)-2020: Total fat (g/d) | Week 0 and Week 12 |
| Food Frequency Questionnaire: Total protein (g/d) | Healthy Eating Index (HEI)-2020: Total protein (g/d) | 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) | Week 0 and Week 12 |
| Food Frequency Questionnaire: Total caffeine (mg/day) | Healthy Eating Index (HEI)-2020: Total caffeine (mg/day) | Week 0 and Week 12 |