AzTrials
AzTrials

Cognitive ChangePhase 1NCT04860778

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

A Phase 1 study testing BDNF Essentials in people with Cognitive Change, run by Researched Nutritionals LLC at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Change
What is being tested?
BDNF Essentials
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
27 Apr 2021to 10 Sep 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Science Inc.

    London, Ontario, N6A5R8

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
BDNF Essentials

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BDNF EssentialsDietary supplement

    Participants will take two capsules, twice daily with water for 84 days.

Study groups in NCT04860778
Study groupRoleWhat they receive
BDNF EssentialsExperimentalA proprietary blend of botanical extracts and isolates.
Receives: Dietary Supplement: BDNF Essentials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cognitive function

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory

    Measured: baseline to day 84

  2. Change in cognitive function

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention

    Measured: baseline to day 84

  3. Change in cognitive function

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing speed

    Measured: baseline to day 84

  4. Change in cognitive function

    Assessed by plasma Brain-Derived Neurotrophic Factor (BDNF) levels

    Measured: baseline to day 84

Secondary outcomes (20)

  1. Change in plasma BDNF levels

    Assessed using the Computerized Mental Performance Assessment System (COMPASS)

    Measured: baseline to day 28

  2. Change in plasma BDNF levels

    Measured: baseline to day 56

  3. Change in memory

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory

    Measured: baseline to day 28

  4. Change in memory

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for memory

    Measured: baseline to day 56

  5. Change in attention

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention

    Measured: baseline to day 28

  6. Change in attention

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for attention

    Measured: baseline to day 56

  7. Change in processing speed

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing

    Measured: baseline to day 28

  8. Change in processing speed

    Assessed using the Computerized Mental Performance Assessment System (COMPASS) test score for processing

    Measured: baseline to day 56

  9. Change in mood

    Assessed by the Profile of Mood States (POMS) score

    Measured: baseline to day 28

  10. Change in mood

    Assessed by the Profile of Mood States (POMS) score

    Measured: baseline to day 56

  11. Change in mood

    Assessed by the Profile of Mood States (POMS) score

    Measured: baseline to day 84

  12. Change in Sleep

    Assessed by the Sleep Quality Questionnaire score

    Measured: baseline to day 28

  13. Change in Sleep

    Assessed by the Sleep Quality Questionnaire score

    Measured: baseline to day 56

  14. Change in Sleep

    Assessed by the Sleep Quality Questionnaire score

    Measured: baseline to day 84

  15. Change in Stress

    Assessed by the Perceived Stress Scale Score

    Measured: baseline to day 28

  16. Change in Stress

    Assessed by the Perceived Stress Scale Score

    Measured: baseline to day 56

  17. Change in Stress

    Assessed by the Perceived Stress Scale Score

    Measured: baseline to day 84

  18. Change in salivary cortisol levels

    Measured: baseline to day 84

  19. Change in serum Interleukin (IL-6) levels

    Measured: baseline to day 84

  20. Change in serum Tumour Necrosis Factor (TNF-alpha) levels

    Measured: baseline to day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2021
  2. Study start27 Apr 2021
  3. Primary completion10 Sep 2021
  4. Study completion10 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860778
Sponsor's protocol ID
21BCHR
Status last verified
Apr 2022
First submitted
22 Apr 2021
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BDNF Essentials in people with Cognitive Change, run by Researched Nutritionals LLC at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive function (time frame: baseline to day 84). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860778.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in