An Open-label, Exploratory Study to Investigate the Efficacy of BDNF Essentials® on Cognition

April 26, 2022 updated by: Researched Nutritionals LLC

An Open-label, Exploratory Study to Investigate the Efficacy of BDNF Essentials® on Cognition in a Healthy Adult Population With Self-reported Memory Complaints

The objective of this open-label, exploratory study is to investigate the efficacy of BDNF Essentials® on cognition in a healthy adult population with self-reported memory complaints. As there is a dearth of available literature on BDNF in this study population, the current study is designed to understand the role of BDNF to inform potential future studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this open-label, exploratory study is to investigate the efficacy of BDNF Essentials® on cognition in a healthy adult population with self-reported memory complaints. As there is a dearth of available literature on BDNF in this study population, the current study is designed to understand the role of BDNF to inform potential future studies. The study population represents a target group of individuals who would benefit from safe and efficacious nutraceuticals for the support of cognitive function. This transitional stage from normal cognition to cognitive impairment is viewed as an opportune window for intervention. This population of participants is being recruited to expand on previously published work on these individual ingredients while limiting confounding variables that could influence outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5R8
        • KGK Science Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females 45 years of age and older
  • Waist circumference < 102 cm (40 inches) in men and < 88 cm (35 inches) in women
  • Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to enrollment

Or,

Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

  • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
  • Double-barrier method
  • Intrauterine devices
  • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)

  • Vasectomy of partner at least 6 months prior to enrollment

    • A score of ≥ 24 on the Mini-Mental State Examination (MMSE 2)
    • Self-reported memory complaints as assessed by the revised Everyday Memory Questionnaire (EMQ) (with a score of ≥ 32)
    • Agrees to maintain current exercise routine, sleep and dietary patterns throughout the study
    • Agrees to avoid high caffeine consumption 24-hours prior to study appointments (examples include but not limited to no more than 2 cups of caffeinated coffee or tea)
    • Agrees to avoid alcohol consumption 24-hours prior to study appointments
    • Willingness to complete questionnaires, and diaries associated with the study and to complete all appointments
    • Provided voluntary, written, informed consent to participate in the study
    • Healthy as determined by medical history and laboratory results as assessed by the QI

Exclusion Criteria:

  • Women who are pregnant, breast feeding, or planning to become pregnant during the study
  • Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
  • Dementia and/or cognitive decline or use of prescribed medications used to for dementia and/or cognitive decline (Section 6.3.1)
  • Prescribed medications for depression that may affect concentration, attention and performance as assessed by the QI (Section 6.3.1)
  • Current use of supplements used for cognition or mood support unless on a stable dose (Section 6.3.2)
  • History of epilepsy, brain injury or trauma as assessed by the QI
  • Self-reported confirmation of sleep disorder as assessed by the QI
  • Prescribed or over-the-counter medications or supplements used for sleep (Section 6.3.1 and 6.3.2)
  • Self reported colour-blindness
  • Prescribed use of antibiotics within 1 month of baseline (Section 6.3.1)
  • Prescribed use of anticoagulants/antiplatelets (Section 6.3.1)
  • Prescribed or chronic use of over-the-counter anti-inflammatory medications (Section 6.3.1 and 6.3.2)
  • Current use of supplements containing the ingredients in the IP unless willing to washout (Section 6.3.2)
  • Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
  • Travelled across 1 or more time zones in the last 3 weeks and/or is anticipating more travel during the study
  • Use of medical cannabinoid products
  • Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic use and occasional use to be assessed by QI on a case-by-case basis
  • Use of tobacco, nicotine, or e-cigarette products within 12 weeks of baseline and during the study period
  • Self-reported alcohol or drug abuse within the last 12 months
  • Self-reported confirmation of HIV-, Hepatitis B- and/or C-positive diagnosis
  • Autoimmune disease including Type I diabetes or are immune compromised
  • Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be assessed by the QI
  • Clinically significant abnormal laboratory results at screening as assessed by the QI
  • Blood donation 30 days prior to enrollment, during the study, or a planned donation within 30 days of the last study appointment
  • Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
  • Individuals who are unable to give informed consent
  • Any other condition or lifestyle factor, that, in the opinion of the QI may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BDNF Essentials
A proprietary blend of botanical extracts and isolates.
Dietary supplement: BDNF Essentials
Participants will take two capsules, twice daily with water for 84 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in cognitive function
Time Frame: baseline to day 84
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
baseline to day 84
Change in cognitive function
Time Frame: baseline to day 84
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
baseline to day 84
Change in cognitive function
Time Frame: baseline to day 84
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing speed
baseline to day 84
Change in cognitive function
Time Frame: baseline to day 84
Assessed by plasma Brain-Derived Neurotrophic Factor (BDNF) levels
baseline to day 84

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in plasma BDNF levels
Time Frame: baseline to day 28
Assessed using the Computerized Mental Performance Assessment System (COMPASS)
baseline to day 28
Change in plasma BDNF levels
Time Frame: baseline to day 56
baseline to day 56
Change in memory
Time Frame: baseline to day 28
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
baseline to day 28
Change in memory
Time Frame: baseline to day 56
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory
baseline to day 56
Change in attention
Time Frame: baseline to day 28
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
baseline to day 28
Change in attention
Time Frame: baseline to day 56
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention
baseline to day 56
Change in processing speed
Time Frame: baseline to day 28
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing
baseline to day 28
Change in processing speed
Time Frame: baseline to day 56
Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing
baseline to day 56
Change in mood
Time Frame: baseline to day 28
Assessed by the Profile of Mood States (POMS) score
baseline to day 28
Change in mood
Time Frame: baseline to day 56
Assessed by the Profile of Mood States (POMS) score
baseline to day 56
Change in mood
Time Frame: baseline to day 84
Assessed by the Profile of Mood States (POMS) score
baseline to day 84
Change in Sleep
Time Frame: baseline to day 28
Assessed by the Sleep Quality Questionnaire score
baseline to day 28
Change in Sleep
Time Frame: baseline to day 56
Assessed by the Sleep Quality Questionnaire score
baseline to day 56
Change in Sleep
Time Frame: baseline to day 84
Assessed by the Sleep Quality Questionnaire score
baseline to day 84
Change in Stress
Time Frame: baseline to day 28
Assessed by the Perceived Stress Scale Score
baseline to day 28
Change in Stress
Time Frame: baseline to day 56
Assessed by the Perceived Stress Scale Score
baseline to day 56
Change in Stress
Time Frame: baseline to day 84
Assessed by the Perceived Stress Scale Score
baseline to day 84
Change in salivary cortisol levels
Time Frame: baseline to day 84
baseline to day 84
Change in serum Interleukin (IL-6) levels
Time Frame: baseline to day 84
baseline to day 84
Change in serum Tumour Necrosis Factor (TNF-alpha) levels
Time Frame: baseline to day 84
baseline to day 84

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change in body weight
Time Frame: baseline to day 84
baseline to day 84
Incidence of adverse events
Time Frame: screening to day 84
screening to day 84
Change in systolic blood pressure
Time Frame: baseline to day 84
baseline to day 84
Change in diastolic blood pressure
Time Frame: baseline to day 84
baseline to day 84
Change in heart rate
Time Frame: baseline to day 84
baseline to day 84
Change in aspartate aminotransferase (AST)
Time Frame: baseline to day 84
baseline to day 84
Change in alanine aminotransferase (ALT)
Time Frame: baseline to day 84
baseline to day 84
Change in alkaline phosphatase (ALP)
Time Frame: baseline to day 84
baseline to day 84
Change in total bilirubin
Time Frame: baseline to day 84
baseline to day 84
Change in creatinine
Time Frame: baseline to day 84
baseline to day 84
Change in sodium
Time Frame: baseline to day 84
baseline to day 84
Change in potassium
Time Frame: baseline to day 84
baseline to day 84
Change in chloride
Time Frame: baseline to day 84
baseline to day 84
Change in glucose
Time Frame: baseline to day 84
baseline to day 84
Change in estimated glomerular filtration rate (eGFR)
Time Frame: baseline to day 84
baseline to day 84
Change in neutrophil count
Time Frame: baseline to day 84
baseline to day 84
Change in eosinophil count
Time Frame: baseline to day 84
baseline to day 84
Change in basophil count
Time Frame: baseline to day 84
baseline to day 84
Change in lymphocyte count
Time Frame: baseline to day 84
baseline to day 84
Change in monocyte count
Time Frame: baseline to day 84
baseline to day 84
Change in red blood cell count
Time Frame: baseline to day 84
baseline to day 84
Change in hemoglobin
Time Frame: baseline to day 84
baseline to day 84
Change in hematocrit
Time Frame: baseline to day 84
baseline to day 84
Change in platelet count
Time Frame: baseline to day 84
baseline to day 84
Change in mean corpuscular volume
Time Frame: baseline to day 84
baseline to day 84
Change in mean corpuscular hemoglobin
Time Frame: baseline to day 84
baseline to day 84
Change in mean corpuscular hemoglobin concentration
Time Frame: baseline to day 84
baseline to day 84
Change in red cell distribution width
Time Frame: baseline to day 84
baseline to day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Researched Nutritionals LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KGK Science Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Crowley, M.D., KGK Science Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21BCHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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