HealthyNCT04389723
Safety and Efficacy Study of Qualia Mind on Cognition in a Healthy Population
A study testing Qualia Mind in people with Healthy and Cognitive Function, run by Neurohacker Collective at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, crossover study designed to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population between ages of 18 and 75 years. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cognitive Function
- What is being tested?
- Qualia Mind
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2020to 15 Sep 2020
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided voluntary, written, informed consent to participate in the study
- Male and female participants between 18 and 75 years of age, inclusive
- BMI between 18.5 to 32.5 kg/m2, inclusive
- 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 screening
- 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:
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- 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 (implanted for at a minimum of 3 months)
- 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 screening
- Men must agree to the use of condoms unless partner is using an acceptable form of female contraception as defined in inclusion #4 during the study period and for at least 7 days after completion of the study
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- A score of ≥ 25 on MMSE-2 (Section 9.7.5)
- Agrees to avoid high caffeine consumption starting 5-days prior to visit 2 and during the study (equivalent to no more than 2 standard cups of caffeinated coffee or tea per day)
- Agrees to avoid caffeine consumption 24 hours prior to in-clinic visits
- Agrees to avoid alcohol consumption 24 hours prior to in-clinic visits
- Agrees to avoid cannabis use 24 hours prior to in-clinic visits
- Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 9 hours of sleep for at least 3 weeks prior to baseline
- Agrees to maintain current sleep schedule throughout study
- Agrees to maintain current level of physical activity and diet throughout the study
- Healthy as determined by medical history and laboratory results as assessed by QI
Who cannot join
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Previous diagnosis of a sleep disorder
- Currently experiencing vivid nightmares or sleepwalking
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm in the last 3 weeks
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- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Type I or Type II diabetes
- A significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune-compromised
- Self-reported diagnosis of HIV-, Hepatitis B- and/or C-positive
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
- Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- Current or history of any significant diseases of the gastrointestinal tract
- Blood/bleeding disorders as determined by laboratory results
- Current use of prescribed medications listed in the protocol
- Current use of over-the-counter medications, supplements, foods and/or drinks listed in the protocol
- Chronic use of cannabinoid products (>2 times/week)
- Use of tobacco products within 60 days of the baseline visit and during the study period
- Self-reported alcohol or drug abuse within the last 12 months
- Self-reported high alcohol intake (average of >2 standard drinks per day or >10 standard drinks per week)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
- Participation in other clinical research trials 30 days prior to screening
- Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety and Efficacy of Qualia Mind on Cognition in a Healthy Population
This is a randomized, double-blind, placebo-controlled, crossover study designed to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population between ages of 18 and 75 years. Qualia Mind is a nootropic supplement containing a complex mixture of vitamins, minerals, amino acids, choline donors, and herbal ingredients. These components have been demonstrated to exert their cognitive effects through distinct mechanisms of action involving cholinergic, glutamatergic, and dopaminergic receptor signalling; neuroplasticity; and modulation of cell membrane structure and metabolism.
Read the detailed description
Qualia Mind is a nootropic supplement containing a complex mixture of vitamins, minerals, amino acids, choline donors, and herbal ingredients. These components have been demonstrated to exert their cognitive effects through distinct mechanisms of action involving cholinergic, glutamatergic, and dopaminergic receptor signalling; neuroplasticity; and modulation of cell membrane structure and metabolism. Vitamin B6 and B12 supplementation have been shown to improve cognitive scores related to memory in healthy participants aged 20 to 92 years. Twenty-eight days of B vitamin complex and vitamin C supplementation increased subjective ratings of concentration, mental stamina, and alertness. Although each B vitamin may exert differential effects on cognition, a higher intake of B vitamins throughout adulthood is associated with greater cognitive function later in life. An acute dose of CDP-choline improved processing speed, memory, verbal learning, and executive functioning in healthy participants who were poor performers on tests at baseline. Cognitive improvement among all participants may have been observed with repeated administration. It is also expected that with the additional administration of uridine monophosphate (UMP) and docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, would have a greater effect on cognitive performance based on preclinical studies describing a synergistic effect between the ingredients. Phosphatidylserine (PS) daily supplementation has strong clinical support for use in healthy humans for enhancing cognition and maintaining cognitive baseline performance. Moreover, the cognitive effects of Ginkgo biloba were found to be superior when complexed with PS. A specific extract of the herbal adaptogen, Bacopa monnieri, prepared from stems, leaves, and roots of the plant has been shown in healthy populations to enhance cognition by improving memory recall, selective attention, and processing speed. Rhodiola rosea, another herbal adaptogen, improved speed, and accuracy, compared to placebo, in a choice reaction time task using an extract derived from roots of the plant following a 4-week supplementation period. Examination of individual and synergistic effects of theobromine and caffeine in preclinical and clinical studies have been generally positive. Several doses of theobromine with caffeine have been shown to improve alertness, working memory, and other cognitive facets. Caffeine in combination with L-theanine has also been demonstrated to improve processing speed and accuracy in an attention-switching task, while improving concentration in a memory task. Other ingredients, such as Celastrus paniculatus, and pyrroloquinoline quinone have preclinical evidence supporting their positive effect on cognition that warrants further investigations in the form of clinical trials.
A previous open-label study in a healthy population consuming Qualia Mind for 5 days assessed cognition using the Cambridge Brain Science Test and found significant improvements in memory, concentration, reasoning, and planning skills compared to baseline. Participants reported a significant 85% improvement in concentration after 5 days of supplementation. These promising preliminary results, however, require placebo-controlled studies to aid their interpretation.
While the interest in enhancing cognitive performance is growing along with the use of brain health supplements, it is important to establish the safety and efficacy of nootropic supplements. Prescription and prohibited stimulant drugs intended to enhance mental performance have been increasing in usage worldwide. In 2017, results from the Global Drug Survey found that 14% of respondents reported using stimulants at least once in the last 12 months, an increase from the 5% reported in the previous year. In the US alone, the use of drugs specifically for cognitive enhancement rose from 20 to 30%. These individuals seeking out cognitive enhancement primarily used prescription drugs, that are designed for individuals with Attention Deficit Hyperactivity Disorder (ADHD), such as the popular methylphenidate (Ritalin) or amphetamine-dextroamphetamine (Adderall).
However, the evidence that these drugs enhance cognition in individuals without ADHD is lacking. Moreover, the misuse of stimulants is associated with adverse effects, such as psychosis, anorexia, cardiovascular events, and sudden death. The alternative nootropic industry of cognitive enhancers is a safe and legal substitute, with supplements designed specifically for healthy individuals. It is likely that stimulant misuse and associated adverse effects will be reduced, with the growing popularity and availability of clinically proven nootropics.
Based on the existing evidence on individual ingredients and preliminary studies on Qualia Mind, the current randomized, double-blind, placebo-controlled, crossover study is designed to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population between ages of 18 and 75 years.
ETHICAL ASPECTS OF THE STUDY
This study will be conducted with the highest respect for the individual participants (i.e., participants) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP.
STATISTICAL EVALUATION
Analysis Plan
The Safety Population will consist of all participants who received any amount of either product and on whom any post-randomization safety information is available.
The Intent-to-Treat (ITT) Population consists of all participants who received either product and on whom any post-randomization efficacy information is available.
The Per Protocol (PP) Population consists of all participants who consumed at least 80% of treatment or placebo doses, do not have any major protocol violations and complete all study visits and procedures connected with measurement of the primary variable.
Statistical Analysis Plan
All hypothesis testing will be carried out at the 5% (2-sided) significance level unless otherwise specified.
All data will be summarised by study group and/or visit. For continuous variables, the minimum and maximum, the arithmetic mean, median and standard deviation will be presented to two decimal places. For categorical variables, counts and percentages will be described. The denominator for each percentage will be the number of subjects within the population study group unless otherwise specified.
The formula for the changes of continuous endpoints from screening/baseline:
Change to Vi = Value at Vi - Value at V screening/baseline For the primary outcomes, analysis of covariance (ANCOVA) will be conducted for the evaluation of the change from baseline to the follow-up visit. The model will include period, group and sequence as fixed effects.
- Conditions
- Healthy, Cognitive Function
- Being tested
- Qualia Mind, Placebo
- Keywords
- Cognition, Nootropic, Dietary Supplement, Healthy, Cambridge Brain Science Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia MindDietary supplement
Multi-ingredient Dietary supplement
PlaceboDietary supplement
Multi-ingredient Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo→ Qualia Mind | Other | Subjects are first administered the placebo then crossover to the investigational product Receives: Dietary Supplement: Qualia Mind; Dietary Supplement: Placebo |
| Qualia Mind→ Placebo | Other | Subjects are first administered the investigational product then crossover to the placebo Receives: Dietary Supplement: Qualia Mind; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the change from baseline in Overall Mental Performance after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Combined Verbal Ability scores after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Combined Reasoning Scores after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
Secondary outcomes (13)
The difference in the change from baseline in combined Short-term Memory Scores after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Verbal Reasoning after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Deductive Reasoning after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Alternating Attention after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Selective Attention after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Planning after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Verbal Short-Term Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Spatial Short- Term Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Episodic Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Spatial Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Working Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Visuospatial Working Memory after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
The difference in the change from baseline in Visuospatial processing after 5 days of supplementation with Qualia Mind compared to placebo
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start12 May 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurohacker Collective
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Rupal Trivedi, MD, Principal investigator, Great Lakes Clinical Trials LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389723
- Sponsor's protocol ID
- 20QCHN
- Status last verified
- Oct 2020
- First submitted
- 30 Apr 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manders M, de Groot LC, van Staveren WA, Wouters-Wesseling W, Mulders AJ, Schols JM, Hoefnagels WH. Effectiveness of nutritional supplements on cognitive functioning in elderly persons: a systematic review. J Gerontol A Biol Sci Med Sci. 2004 Oct;59(10):1041-9. doi: 10.1093/gerona/59.10.m1041.
PubMed 15528776Kennedy DO, Veasey RC, Watson AW, Dodd FL, Jones EK, Tiplady B, Haskell CF. Vitamins and psychological functioning: a mobile phone assessment of the effects of a B vitamin complex, vitamin C and minerals on cognitive performance and subjective mood and energy. Hum Psychopharmacol. 2011 Jun-Jul;26(4-5):338-47. doi: 10.1002/hup.1216. Epub 2011 Jul 12.
PubMed 21751253Qin B, Xun P, Jacobs DR Jr, Zhu N, Daviglus ML, Reis JP, Steffen LM, Van Horn L, Sidney S, He K. Intake of niacin, folate, vitamin B-6, and vitamin B-12 through young adulthood and cognitive function in midlife: the Coronary Artery Risk Development in Young Adults (CARDIA) study. Am J Clin Nutr. 2017 Oct;106(4):1032-1040. doi: 10.3945/ajcn.117.157834. Epub 2017 Aug 2.
PubMed 28768650Knott V, de la Salle S, Choueiry J, Impey D, Smith D, Smith M, Beaudry E, Saghir S, Ilivitsky V, Labelle A. Neurocognitive effects of acute choline supplementation in low, medium and high performer healthy volunteers. Pharmacol Biochem Behav. 2015 Apr;131:119-29. doi: 10.1016/j.pbb.2015.02.004. Epub 2015 Feb 12.
PubMed 25681529Holguin S, Martinez J, Chow C, Wurtman R. Dietary uridine enhances the improvement in learning and memory produced by administering DHA to gerbils. FASEB J. 2008 Nov;22(11):3938-46. doi: 10.1096/fj.08-112425. Epub 2008 Jul 7.
PubMed 18606862Glade MJ, Smith K. Phosphatidylserine and the human brain. Nutrition. 2015 Jun;31(6):781-6. doi: 10.1016/j.nut.2014.10.014. Epub 2014 Nov 4.
PubMed 25933483Kennedy DO, Haskell CF, Mauri PL, Scholey AB. Acute cognitive effects of standardised Ginkgo biloba extract complexed with phosphatidylserine. Hum Psychopharmacol. 2007 Jun;22(4):199-210. doi: 10.1002/hup.837.
PubMed 17457961Benson S, Downey LA, Stough C, Wetherell M, Zangara A, Scholey A. An acute, double-blind, placebo-controlled cross-over study of 320 mg and 640 mg doses of Bacopa monnieri (CDRI 08) on multitasking stress reactivity and mood. Phytother Res. 2014 Apr;28(4):551-9. doi: 10.1002/ptr.5029. Epub 2013 Jun 21.
PubMed 23788517Pase MP, Kean J, Sarris J, Neale C, Scholey AB, Stough C. The cognitive-enhancing effects of Bacopa monnieri: a systematic review of randomized, controlled human clinical trials. J Altern Complement Med. 2012 Jul;18(7):647-52. doi: 10.1089/acm.2011.0367. Epub 2012 Jul 2.
PubMed 22747190Jowko E, Sadowski J, Dlugolecka B, Gierczuk D, Opaszowski B, Cieslinski I. Effects of Rhodiola rosea supplementation on mental performance, physical capacity, and oxidative stress biomarkers in healthy men. J Sport Health Sci. 2018 Oct;7(4):473-480. doi: 10.1016/j.jshs.2016.05.005. Epub 2016 May 20.
PubMed 30450257Cova I, Leta V, Mariani C, Pantoni L, Pomati S. Exploring cocoa properties: is theobromine a cognitive modulator? Psychopharmacology (Berl). 2019 Feb;236(2):561-572. doi: 10.1007/s00213-019-5172-0. Epub 2019 Jan 31.
PubMed 30706099Owen GN, Parnell H, De Bruin EA, Rycroft JA. The combined effects of L-theanine and caffeine on cognitive performance and mood. Nutr Neurosci. 2008 Aug;11(4):193-8. doi: 10.1179/147683008X301513.
PubMed 18681988Ohwada K, Takeda H, Yamazaki M, Isogai H, Nakano M, Shimomura M, Fukui K, Urano S. Pyrroloquinoline Quinone (PQQ) Prevents Cognitive Deficit Caused by Oxidative Stress in Rats. J Clin Biochem Nutr. 2008 Jan;42(1):29-34. doi: 10.3164/jcbn.2008005.
PubMed 18231627Bhanumathy M, Harish MS, Shivaprasad HN, Sushma G. Nootropic activity of Celastrus paniculatus seed. Pharm Biol. 2010 Mar;48(3):324-7. doi: 10.3109/13880200903127391.
PubMed 20645820Pan X, Gong N, Zhao J, Yu Z, Gu F, Chen J, Sun X, Zhao L, Yu M, Xu Z, Dong W, Qin Y, Fei G, Zhong C, Xu TL. Powerful beneficial effects of benfotiamine on cognitive impairment and beta-amyloid deposition in amyloid precursor protein/presenilin-1 transgenic mice. Brain. 2010 May;133(Pt 5):1342-51. doi: 10.1093/brain/awq069. Epub 2010 Apr 12.
PubMed 20385653
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Safety and Efficacy of Qualia Mind on Cognition in a Healthy Population
- ClinicalTrials.gov ID
- NCT04389723
- Acronym / sponsor ID
- 20QCHN
- Conditions
- Healthy, Cognitive Function
- Keywords
- Cognition, Nootropic, Dietary Supplement, Healthy, Cambridge Brain Science Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neurohacker CollectiveIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 12 May 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, crossover study designed to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population between ages of 18 and 75 years. Qualia Mind is a nootropic supplement containing a complex mixture of vitamins, minerals, amino acids, choline donors, and herbal ingredients. These components have been demonstrated to exert their cognitive effects through distinct mechanisms of action involving cholinergic, glutamatergic, and dopaminergic receptor signalling; neuroplasticity; and modulation of cell membrane structure and metabolism.
Detailed description
Qualia Mind is a nootropic supplement containing a complex mixture of vitamins, minerals, amino acids, choline donors, and herbal ingredients. These components have been demonstrated to exert their cognitive effects through distinct mechanisms of action involving cholinergic, glutamatergic, and dopaminergic receptor signalling; neuroplasticity; and modulation of cell membrane structure and metabolism. Vitamin B6 and B12 supplementation have been shown to improve cognitive scores related to memory in healthy participants aged 20 to 92 years. Twenty-eight days of B vitamin complex and vitamin C supplementation increased subjective ratings of concentration, mental stamina, and alertness. Although each B vitamin may exert differential effects on cognition, a higher intake of B vitamins throughout adulthood is associated with greater cognitive function later in life. An acute dose of CDP-choline improved processing speed, memory, verbal learning, and executive functioning in healthy participants who were poor performers on tests at baseline. Cognitive improvement among all participants may have been observed with repeated administration. It is also expected that with the additional administration of uridine monophosphate (UMP) and docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid, would have a greater effect on cognitive performance based on preclinical studies describing a synergistic effect between the ingredients. Phosphatidylserine (PS) daily supplementation has strong clinical support for use in healthy humans for enhancing cognition and maintaining cognitive baseline performance. Moreover, the cognitive effects of Ginkgo biloba were found to be superior when complexed with PS. A specific extract of the herbal adaptogen, Bacopa monnieri, prepared from stems, leaves, and roots of the plant has been shown in healthy populations to enhance cognition by improving memory recall, selective attention, and processing speed. Rhodiola rosea, another herbal adaptogen, improved speed, and accuracy, compared to placebo, in a choice reaction time task using an extract derived from roots of the plant following a 4-week supplementation period. Examination of individual and synergistic effects of theobromine and caffeine in preclinical and clinical studies have been generally positive. Several doses of theobromine with caffeine have been shown to improve alertness, working memory, and other cognitive facets. Caffeine in combination with L-theanine has also been demonstrated to improve processing speed and accuracy in an attention-switching task, while improving concentration in a memory task. Other ingredients, such as Celastrus paniculatus, and pyrroloquinoline quinone have preclinical evidence supporting their positive effect on cognition that warrants further investigations in the form of clinical trials.
A previous open-label study in a healthy population consuming Qualia Mind for 5 days assessed cognition using the Cambridge Brain Science Test and found significant improvements in memory, concentration, reasoning, and planning skills compared to baseline. Participants reported a significant 85% improvement in concentration after 5 days of supplementation. These promising preliminary results, however, require placebo-controlled studies to aid their interpretation.
While the interest in enhancing cognitive performance is growing along with the use of brain health supplements, it is important to establish the safety and efficacy of nootropic supplements. Prescription and prohibited stimulant drugs intended to enhance mental performance have been increasing in usage worldwide. In 2017, results from the Global Drug Survey found that 14% of respondents reported using stimulants at least once in the last 12 months, an increase from the 5% reported in the previous year. In the US alone, the use of drugs specifically for cognitive enhancement rose from 20 to 30%. These individuals seeking out cognitive enhancement primarily used prescription drugs, that are designed for individuals with Attention Deficit Hyperactivity Disorder (ADHD), such as the popular methylphenidate (Ritalin) or amphetamine-dextroamphetamine (Adderall).
However, the evidence that these drugs enhance cognition in individuals without ADHD is lacking. Moreover, the misuse of stimulants is associated with adverse effects, such as psychosis, anorexia, cardiovascular events, and sudden death. The alternative nootropic industry of cognitive enhancers is a safe and legal substitute, with supplements designed specifically for healthy individuals. It is likely that stimulant misuse and associated adverse effects will be reduced, with the growing popularity and availability of clinically proven nootropics.
Based on the existing evidence on individual ingredients and preliminary studies on Qualia Mind, the current randomized, double-blind, placebo-controlled, crossover study is designed to investigate the safety and efficacy of Qualia Mind on cognition in a healthy adult population between ages of 18 and 75 years.
ETHICAL ASPECTS OF THE STUDY
This study will be conducted with the highest respect for the individual participants (i.e., participants) according to the protocol, the ethical principles that have their origin in the Declaration of Helsinki, and the ICH Harmonised Tripartite Guideline for GCP.
STATISTICAL EVALUATION
Analysis Plan
The Safety Population will consist of all participants who received any amount of either product and on whom any post-randomization safety information is available.
The Intent-to-Treat (ITT) Population consists of all participants who received either product and on whom any post-randomization efficacy information is available.
The Per Protocol (PP) Population consists of all participants who consumed at least 80% of treatment or placebo doses, do not have any major protocol violations and complete all study visits and procedures connected with measurement of the primary variable.
Statistical Analysis Plan
All hypothesis testing will be carried out at the 5% (2-sided) significance level unless otherwise specified.
All data will be summarised by study group and/or visit. For continuous variables, the minimum and maximum, the arithmetic mean, median and standard deviation will be presented to two decimal places. For categorical variables, counts and percentages will be described. The denominator for each percentage will be the number of subjects within the population study group unless otherwise specified.
The formula for the changes of continuous endpoints from screening/baseline:
Change to Vi = Value at Vi - Value at V screening/baseline For the primary outcomes, analysis of covariance (ANCOVA) will be conducted for the evaluation of the change from baseline to the follow-up visit. The model will include period, group and sequence as fixed effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo→ Qualia Mind | Other | Dietary Supplement: Qualia Mind, Dietary Supplement: PlaceboSubjects are first administered the placebo then crossover to the investigational product |
| Qualia Mind→ Placebo | Other | Dietary Supplement: Qualia Mind, Dietary Supplement: PlaceboSubjects are first administered the investigational product then crossover to the placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Provided voluntary, written, informed consent to participate in the study
- Male and female participants between 18 and 75 years of age, inclusive
- BMI between 18.5 to 32.5 kg/m2, inclusive
- 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 screening
- or,
Key exclusion criteria (29 listed)
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Women who are pregnant, breastfeeding or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Previous diagnosis of a sleep disorder
- Currently experiencing vivid nightmares or sleepwalking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia MindMulti-ingredient Dietary supplement | Dietary supplement | Placebo→ Qualia Mind, Qualia Mind→ Placebo |
| PlaceboMulti-ingredient Placebo | Dietary supplement | Placebo→ Qualia Mind, Qualia Mind→ Placebo |
Primary outcome
The difference in the change from baseline in Overall Mental Performance after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
The difference in the change from baseline in Combined Verbal Ability scores after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
The difference in the change from baseline in Combined Reasoning Scores after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
Assessed using Cambridge Brain Science Test comprising a total of 12 assessments, each of which is a neurocognitive task that measures a core element of cognition. Four cognitive domains Overall Mental Performance, Verbal Ability, Reasoning and Short-term Memory scores will be calculated from using scores from the 12 assessments. Based on previous studies (1), these scores may range from -3.70 to 4.01 or beyond. Scores greater than 0 are above average and those less than 0 are below average. Scores for individual assessments may range from -39 through 240 or beyond.
13 secondary outcomes
The difference in the change from baseline in combined Short-term Memory Scores after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Verbal Reasoning after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Deductive Reasoning after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Alternating Attention after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Selective Attention after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Planning after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Verbal Short-Term Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Spatial Short- Term Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Episodic Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Spatial Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Working Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Visuospatial Working Memory after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
The difference in the change from baseline in Visuospatial processing after 5 days of supplementation with Qualia Mind compared to placebo
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Background: PubMed 15528776Manders M, de Groot LC, van Staveren WA, Wouters-Wesseling W, Mulders AJ, Schols JM, Hoefnagels WH. Effectiveness of nutritional supplements on cognitive functioning in elderly persons: a systematic review. J Gerontol A Biol Sci Med Sci. 2004 Oct;59(10):1041-9. doi: 10.1093/gerona/59.10.m1041.
- Background: PubMed 21751253Kennedy DO, Veasey RC, Watson AW, Dodd FL, Jones EK, Tiplady B, Haskell CF. Vitamins and psychological functioning: a mobile phone assessment of the effects of a B vitamin complex, vitamin C and minerals on cognitive performance and subjective mood and energy. Hum Psychopharmacol. 2011 Jun-Jul;26(4-5):338-47. doi: 10.1002/hup.1216. Epub 2011 Jul 12.
- Background: PubMed 28768650Qin B, Xun P, Jacobs DR Jr, Zhu N, Daviglus ML, Reis JP, Steffen LM, Van Horn L, Sidney S, He K. Intake of niacin, folate, vitamin B-6, and vitamin B-12 through young adulthood and cognitive function in midlife: the Coronary Artery Risk Development in Young Adults (CARDIA) study. Am J Clin Nutr. 2017 Oct;106(4):1032-1040. doi: 10.3945/ajcn.117.157834. Epub 2017 Aug 2.
- Background: PubMed 25681529Knott V, de la Salle S, Choueiry J, Impey D, Smith D, Smith M, Beaudry E, Saghir S, Ilivitsky V, Labelle A. Neurocognitive effects of acute choline supplementation in low, medium and high performer healthy volunteers. Pharmacol Biochem Behav. 2015 Apr;131:119-29. doi: 10.1016/j.pbb.2015.02.004. Epub 2015 Feb 12.
- Background: PubMed 18606862Holguin S, Martinez J, Chow C, Wurtman R. Dietary uridine enhances the improvement in learning and memory produced by administering DHA to gerbils. FASEB J. 2008 Nov;22(11):3938-46. doi: 10.1096/fj.08-112425. Epub 2008 Jul 7.
- Background: PubMed 25933483Glade MJ, Smith K. Phosphatidylserine and the human brain. Nutrition. 2015 Jun;31(6):781-6. doi: 10.1016/j.nut.2014.10.014. Epub 2014 Nov 4.
- Background: PubMed 17457961Kennedy DO, Haskell CF, Mauri PL, Scholey AB. Acute cognitive effects of standardised Ginkgo biloba extract complexed with phosphatidylserine. Hum Psychopharmacol. 2007 Jun;22(4):199-210. doi: 10.1002/hup.837.
- Background: PubMed 23788517Benson S, Downey LA, Stough C, Wetherell M, Zangara A, Scholey A. An acute, double-blind, placebo-controlled cross-over study of 320 mg and 640 mg doses of Bacopa monnieri (CDRI 08) on multitasking stress reactivity and mood. Phytother Res. 2014 Apr;28(4):551-9. doi: 10.1002/ptr.5029. Epub 2013 Jun 21.
- Background: PubMed 22747190Pase MP, Kean J, Sarris J, Neale C, Scholey AB, Stough C. The cognitive-enhancing effects of Bacopa monnieri: a systematic review of randomized, controlled human clinical trials. J Altern Complement Med. 2012 Jul;18(7):647-52. doi: 10.1089/acm.2011.0367. Epub 2012 Jul 2.
- Background: PubMed 30450257Jowko E, Sadowski J, Dlugolecka B, Gierczuk D, Opaszowski B, Cieslinski I. Effects of Rhodiola rosea supplementation on mental performance, physical capacity, and oxidative stress biomarkers in healthy men. J Sport Health Sci. 2018 Oct;7(4):473-480. doi: 10.1016/j.jshs.2016.05.005. Epub 2016 May 20.
- Background: PubMed 30706099Cova I, Leta V, Mariani C, Pantoni L, Pomati S. Exploring cocoa properties: is theobromine a cognitive modulator? Psychopharmacology (Berl). 2019 Feb;236(2):561-572. doi: 10.1007/s00213-019-5172-0. Epub 2019 Jan 31.
- Background: PubMed 18681988Owen GN, Parnell H, De Bruin EA, Rycroft JA. The combined effects of L-theanine and caffeine on cognitive performance and mood. Nutr Neurosci. 2008 Aug;11(4):193-8. doi: 10.1179/147683008X301513.
- Pilot study: Qualia Mind: Neurohacker CollectiveLink provided by the sponsor.
- Use of 'smart drugs' on the riseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupal Trivedi, MD principal investigator
Great Lakes Clinical Trials LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Mind in people with Healthy and Cognitive Function, run by Neurohacker Collective at 1 site in United States.
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 22 inclusion and 29 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 9 Oct 2020. 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 United States. 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.
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?
The difference in the change from baseline in Overall Mental Performance after 5 days of supplementation with Qualia Mind compared to placebo (time frame: 5 days). The study lists 3 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 NCT04389723, which also lists 20 linked publications.
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 9 Oct 2020.