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

NCT06837246 | Recruiting

• 1 other identifier: BIO-2409
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognition; Concentration; Attention; Focus

Keywords

cognition; concentration; attention; problem-solving; capsule; clinical trial; placebo-controlled; focus; memory

Outcome Measures

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

  Week 0, Week 6, and Week 12

Secondary Outcomes (21)

• Feature Match

  Week 0, Week 6, and Week 12

• SART Test

  Week 0, Week 6, and Week 12

• Double Trouble

  Week 0, Week 6, and Week 12

• Spatial Span

  Week 0, Week 6, and Week 12

• Token Search

  Week 0, Week 6, and Week 12

Study Arms (2)

Cognitive Nutritional Supplement

PLACEBO COMPARATOR

Intervention is pills of cognitive nutrient

Dietary Supplement: Cognitive Nutritional Supplement

Placebo

ACTIVE COMPARATOR

Intervention is pills of matching placebo

Other: Placebo

Interventions

Cognitive Nutritional Supplement DIETARY_SUPPLEMENT

Pills of cognitive nutritional supplement

Cognitive Nutritional Supplement

Placebo OTHER

Matching placebo to active

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing to review and follow all training materials provided.
• 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.
• 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.
• Willing to maintain habitual diet and physical activity patterns throughout the study.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pharmavite LLC: lead
• Balchem Corporation: collaborator
• Biofortis, Inc. (a Mérieux NutriSciences company): collaborator

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

RECRUITING

Central Study Contacts

Elizabeth A Antoo, MD

CONTACT

6306172000; elizabeth.antoo@mxns.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: February 24, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)