Safety and Efficacy Study of Qualia Mind on Cognition in a Healthy Population
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04389723 |
Recruitment Status :
Completed
First Posted : May 15, 2020
Last Update Posted : October 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Cognitive Function | Dietary Supplement: Qualia Mind Dietary Supplement: Placebo | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
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 |
Actual Study Start Date : | May 12, 2020 |
Actual Primary Completion Date : | September 15, 2020 |
Actual Study Completion Date : | September 15, 2020 |
Arm | Intervention/treatment |
---|---|
Placebo→ Qualia Mind
Subjects are first administered the placebo then crossover to the investigational product
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Dietary Supplement: Qualia Mind
Multi-ingredient Dietary supplement Dietary Supplement: Placebo Multi-ingredient Placebo |
Qualia Mind→ Placebo
Subjects are first administered the investigational product then crossover to the placebo
|
Dietary Supplement: Qualia Mind
Multi-ingredient Dietary supplement Dietary Supplement: Placebo Multi-ingredient Placebo |
- 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.
- 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 ]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 Verbal Reasoning 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 Deductive Reasoning 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 Alternating Attention 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 Selective Attention 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 Planning 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 Verbal Short-Term Memory 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 Spatial Short- Term Memory 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 Episodic Memory 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 Spatial Memory 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 Working Memory 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 Visuospatial Working Memory 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 Visuospatial processing 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.
- Incidence of pre-emergent adverse eventsafter 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Incidence of post-emergent adverse events after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in systolic blood pressure after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in diastolic blood pressure after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in heart rate after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood alanine aminotransferase (ALT) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood creatinine after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood aspartate transaminase (AST) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood total bilirubin after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood sodium (Na) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood potassium (K) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood chloride (Cl) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood glucose after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in blood estimated glomerular filtration rate (eGFR) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in white blood cell (WBC) count after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in neutrophils after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in lymphocytes after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in monocytes after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in eosinophils after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in basophils after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in red blood cell (RBC) count after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in hemoglobin after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]
- Change in hematocrit after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in platelet count after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in mean corpuscular volume (MCV) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in mean corpuscular hemoglobin (MCH) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in mean corpuscular hemoglobin concentration (MCHC) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in red cell distribution width (RDW) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))
- Change in mean platelet volume (MPV) after 5 days of supplementation with Qualia Mind compared to placebo [ Time Frame: 5 days ]Parameters to be assessed are: white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), red blood cell (RBC) count, hemoglobin, hematocrit, platelet count, RBC indices (mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red cell distribution width (RDW), mean platelet volume (MPV))

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389723
United States, Illinois | |
Great Lakes Clinical Trials | |
Chicago, Illinois, United States, 60640 |
Principal Investigator: | Rupal Trivedi, MD | Great Lakes Clinical Trials LLC |
Publications:
Responsible Party: | Neurohacker Collective |
ClinicalTrials.gov Identifier: | NCT04389723 |
Other Study ID Numbers: |
20QCHN |
First Posted: | May 15, 2020 Key Record Dates |
Last Update Posted: | October 9, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cognition Nootropic Dietary Supplement Healthy Cambridge Brain Science Test |