Clinical trial NCT04860778: An Open-label, Exploratory Study to Investigate the Efficacy of BDNF Essentials® on Cognition
Official title: An Open-label, Exploratory Study to Investigate the Efficacy of BDNF Essentials® on Cognition in a Healthy Adult Population With Self-reported Memory Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Change
Lead sponsor: Researched Nutritionals LLC
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2021-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in cognitive function
timeFrame: baseline to day 84
measure: Change in cognitive function
timeFrame: baseline to day 84
measure: Change in cognitive function
timeFrame: baseline to day 84
measure: Change in cognitive function
timeFrame: baseline to day 84
Secondary outcomes:
measure: Change in plasma BDNF levels
timeFrame: baseline to day 28
measure: Change in plasma BDNF levels
timeFrame: baseline to day 56
measure: Change in memory
timeFrame: baseline to day 28
measure: Change in memory
timeFrame: baseline to day 56
measure: Change in attention
timeFrame: baseline to day 28
measure: Change in attention
timeFrame: baseline to day 56
measure: Change in processing speed
timeFrame: baseline to day 28
measure: Change in processing speed
timeFrame: baseline to day 56
measure: Change in mood
timeFrame: baseline to day 28
measure: Change in mood
timeFrame: baseline to day 56
measure: Change in mood
timeFrame: baseline to day 84
measure: Change in Sleep
timeFrame: baseline to day 28
measure: Change in Sleep
timeFrame: baseline to day 56
measure: Change in Sleep
timeFrame: baseline to day 84
measure: Change in Stress
timeFrame: baseline to day 28
measure: Change in Stress
timeFrame: baseline to day 56
measure: Change in Stress
timeFrame: baseline to day 84
measure: Change in salivary cortisol levels
timeFrame: baseline to day 84
measure: Change in serum Interleukin (IL-6) levels
timeFrame: baseline to day 84
measure: Change in serum Tumour Necrosis Factor (TNF-alpha) levels
timeFrame: baseline to day 84
Other outcomes:
measure: Change in body weight
timeFrame: baseline to day 84
measure: Incidence of adverse events
timeFrame: screening to day 84
measure: Change in systolic blood pressure
timeFrame: baseline to day 84
measure: Change in diastolic blood pressure
timeFrame: baseline to day 84
measure: Change in heart rate
timeFrame: baseline to day 84
measure: Change in aspartate aminotransferase (AST)
timeFrame: baseline to day 84
measure: Change in alanine aminotransferase (ALT)
timeFrame: baseline to day 84
measure: Change in alkaline phosphatase (ALP)
timeFrame: baseline to day 84
measure: Change in total bilirubin
timeFrame: baseline to day 84
measure: Change in creatinine
timeFrame: baseline to day 84
measure: Change in sodium
timeFrame: baseline to day 84
measure: Change in potassium
timeFrame: baseline to day 84
measure: Change in chloride
timeFrame: baseline to day 84
measure: Change in glucose
timeFrame: baseline to day 84
measure: Change in estimated glomerular filtration rate (eGFR)
timeFrame: baseline to day 84
measure: Change in neutrophil count
timeFrame: baseline to day 84
measure: Change in eosinophil count
timeFrame: baseline to day 84
measure: Change in basophil count
timeFrame: baseline to day 84
measure: Change in lymphocyte count
timeFrame: baseline to day 84
measure: Change in monocyte count
timeFrame: baseline to day 84
measure: Change in red blood cell count
timeFrame: baseline to day 84
measure: Change in hemoglobin
timeFrame: baseline to day 84
measure: Change in hematocrit
timeFrame: baseline to day 84
measure: Change in platelet count
timeFrame: baseline to day 84
measure: Change in mean corpuscular volume
timeFrame: baseline to day 84
measure: Change in mean corpuscular hemoglobin
timeFrame: baseline to day 84
measure: Change in mean corpuscular hemoglobin concentration
timeFrame: baseline to day 84
measure: Change in red cell distribution width
timeFrame: baseline to day 84
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: