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

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess Cognitive Effects of Cognitive Nutritional Supplementation in the General Population

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 Overview

• Status: Recruiting
• Conditions: Cognition; Attention; Concentration; Focus
• Intervention / Treatment: Dietary supplement: Cognitive Nutritional Supplement; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 422
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth A Antoo, MD; Phone Number: 6306172000; Email: elizabeth.antoo@mxns.com

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Recruiting
      • Biofortis Innovation Services
      • Contact: Elizabeth A Antoo, MD; Phone Number: 6306172000; Email: elizabeth.antoo@mxns.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, ≥25 to ≤65 years of age at screening.
2. English is the primary spoken language.
3. Able to operate a study-provided iPad connected to the internet with a strong and reliable internet connection.
4. Willing to consume 3 capsules per day for 12 weeks.
5. Willing to review and follow all training materials provided.
6. Willing to avoid alcohol, marijuana/hemp products (including CBD products), and vigorous physical activity 24 h prior to the baseline (week 0), mid-point (Week 6), and end of study (Week 12) cognition testing days.
7. Non-user or former user (cessation ≥12 months of screening) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco, nicotine gums or lozenges) with no plans to begin use during the study period.
8. Willing to maintain habitual diet and physical activity patterns throughout the study.
9. Willing to refrain from exclusionary medications, supplements, and products throughout the study.
10. Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.

Exclusion Criteria:

Cognition related criteria

1. Diagnosed neurological disorder such as Alzheimer's disease, Parkinson's disease, stroke, intracranial hemorrhage, or any brain lesions including tumors.
2. 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.
3. Any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies.
4. Elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
5. Color blindness or visual impairments that cannot be corrected with glasses or contact lenses.
6. Diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift of overnight workers).
7. 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.
8. Diagnosis of a learning and/or behavioral disorders such as dyslexia.
9. Diagnosis of attention-deficit/hyperactivity disorder (ADHD).
10. 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.

11. 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

12. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.

13. 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

14. Exposure to any non-registered drug product or has participated in another intervention study within 30 days prior to screening.
15. 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).
16. Another household member is a current participant in this study.
17. 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

• Tobacco / nicotine products within 12 months of screening and throughout the study period
• Any non-registered drug product within 30 days of screening
• Alcohol within 24 h of each cognition test day
• Marijuana/hemp products (including CBD products) within 24 h of each cognition test day
• Current use of any medication used to treat mental health disorders, such as major depressive disorder or any anxiety disorder
• Current use of any medications used to treat ADHD
• Current use of any dietary supplements, other than a conventional once-daily multivitamin/mineral supplement that does not contain certain nutrient with cognitive effect. Participants will be allowed to discontinue use of exclusionary dietary supplements during the screening period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cognitive Nutritional Supplement; Intervention is pills of cognitive nutrient	Dietary supplement: Cognitive Nutritional Supplement; Pills of cognitive nutritional supplement
Active Comparator: Placebo; Intervention is pills of matching placebo	Other: Placebo; Matching placebo to active

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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]	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

Collaborators and Investigators

• Sponsor: Pharmavite LLC
• Collaborators: Balchem Corporation; Biofortis, Inc. (a Mérieux NutriSciences company)

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: memory; cognition; clinical trial; capsule; placebo-controlled; concentration; attention; problem-solving; focus
• Other Study ID Numbers: BIO-2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No