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

Official title

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

Overview

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.

Interventions

• Dietary supplement Cognitive Nutritional Supplement
  Pills of cognitive nutritional supplement
• Other Placebo
  Matching placebo to active

Primary outcome measures

• Feature Match [Time frame: Week 0, Week 6, and Week 12]

Secondary outcome measures (12)

• Feature Match [Time frame: Week 0, Week 6, and Week 12]
• SART Test [Time frame: Week 0, Week 6, and Week 12]
• Double Trouble [Time frame: Week 0, Week 6, and Week 12]
• Spatial Span [Time frame: Week 0, Week 6, and Week 12]
• Token Search [Time frame: Week 0, Week 6, and Week 12]
• Rotations [Time frame: Week 0, Week 6, and Week 12]
• Number Ladder [Time frame: Week 0, Week 6, and Week 12]
• Paired Associates [Time frame: Week 0, Week 6, and Week 12]
• Odd One Out [Time frame: Week 0, Week 6, and Week 12]
• Polygons [Time frame: Week 0, Week 6, and Week 12]
• Grammatical Reasoning [Time frame: Week 0, Week 6, and Week 12]
• Digit Span [Time frame: Week 0, Week 6, and Week 12]

Eligibility criteria

Inclusion criteria

• 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.
• Willing to refrain from exclusionary medications, supplements, and products 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.

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Biofortis Innovation Services — Addison

Identifiers

NCT: NCT06837246 · BIO-2409

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗