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

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: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: BDNF Essentials

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: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in cognitive function	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory	baseline to day 84
Change in cognitive function	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention	baseline to day 84
Change in cognitive function	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing speed	baseline to day 84
Change in cognitive function	Assessed by plasma Brain-Derived Neurotrophic Factor (BDNF) levels	baseline to day 84

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma BDNF levels	Assessed using the Computerized Mental Performance Assessment System (COMPASS)	baseline to day 28
Change in plasma BDNF levels		baseline to day 56
Change in memory	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory	baseline to day 28
Change in memory	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory	baseline to day 56
Change in attention	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention	baseline to day 28
Change in attention	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention	baseline to day 56
Change in processing speed	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing	baseline to day 28
Change in processing speed	Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing	baseline to day 56
Change in mood	Assessed by the Profile of Mood States (POMS) score	baseline to day 28
Change in mood	Assessed by the Profile of Mood States (POMS) score	baseline to day 56
Change in mood	Assessed by the Profile of Mood States (POMS) score	baseline to day 84
Change in Sleep	Assessed by the Sleep Quality Questionnaire score	baseline to day 28
Change in Sleep	Assessed by the Sleep Quality Questionnaire score	baseline to day 56
Change in Sleep	Assessed by the Sleep Quality Questionnaire score	baseline to day 84
Change in Stress	Assessed by the Perceived Stress Scale Score	baseline to day 28
Change in Stress	Assessed by the Perceived Stress Scale Score	baseline to day 56
Change in Stress	Assessed by the Perceived Stress Scale Score	baseline to day 84
Change in salivary cortisol levels		baseline to day 84
Change in serum Interleukin (IL-6) levels		baseline to day 84
Change in serum Tumour Necrosis Factor (TNF-alpha) levels		baseline to day 84

Other Outcome Measures

Outcome Measure	Time Frame
Change in body weight	baseline to day 84
Incidence of adverse events	screening to day 84
Change in systolic blood pressure	baseline to day 84
Change in diastolic blood pressure	baseline to day 84
Change in heart rate	baseline to day 84
Change in aspartate aminotransferase (AST)	baseline to day 84
Change in alanine aminotransferase (ALT)	baseline to day 84
Change in alkaline phosphatase (ALP)	baseline to day 84
Change in total bilirubin	baseline to day 84
Change in creatinine	baseline to day 84
Change in sodium	baseline to day 84
Change in potassium	baseline to day 84
Change in chloride	baseline to day 84
Change in glucose	baseline to day 84
Change in estimated glomerular filtration rate (eGFR)	baseline to day 84
Change in neutrophil count	baseline to day 84
Change in eosinophil count	baseline to day 84
Change in basophil count	baseline to day 84
Change in lymphocyte count	baseline to day 84
Change in monocyte count	baseline to day 84
Change in red blood cell count	baseline to day 84
Change in hemoglobin	baseline to day 84
Change in hematocrit	baseline to day 84
Change in platelet count	baseline to day 84
Change in mean corpuscular volume	baseline to day 84
Change in mean corpuscular hemoglobin	baseline to day 84
Change in mean corpuscular hemoglobin concentration	baseline to day 84
Change in red cell distribution width	baseline to day 84

Collaborators and Investigators

• Sponsor: Researched Nutritionals LLC
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: David Crowley, M.D., KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID 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