Safety and Efficacy Study of Qualia Mind on Cognition in a Healthy Population

NCT04389723 | Completed

• 1 other identifier: 20QCHN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Cognitive Function

Keywords

Cognition; Nootropic; Dietary Supplement; Healthy; Cambridge Brain Science Test

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  5 days

• The difference in the change from baseline in Verbal Reasoning after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

• The difference in the change from baseline in Deductive Reasoning after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

• The difference in the change from baseline in Alternating Attention after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

• The difference in the change from baseline in Selective Attention after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

Other Outcomes (29)

• Incidence of pre-emergent adverse eventsafter 5 days of supplementation with Qualia Mind compared to placebo

  5 days

• Incidence of post-emergent adverse events after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

• Change in systolic blood pressure after 5 days of supplementation with Qualia Mind compared to placebo

  5 days

Study Arms (2)

Placebo→ Qualia Mind

OTHER

Subjects are first administered the placebo then crossover to the investigational product

Dietary Supplement: Qualia Mind; Dietary Supplement: Placebo

Qualia Mind→ Placebo

OTHER

Subjects are first administered the investigational product then crossover to the placebo

Dietary Supplement: Qualia Mind; Dietary Supplement: Placebo

Interventions

Qualia Mind DIETARY_SUPPLEMENT

Multi-ingredient Dietary supplement

Placebo→ Qualia Mind; Qualia Mind→ Placebo

Placebo DIETARY_SUPPLEMENT

Multi-ingredient Placebo

Placebo→ Qualia Mind; Qualia Mind→ Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurohacker Collective: lead
• KGK Science Inc.: collaborator

Study Sites (1)

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Related Publications (20)

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Related Links

• Pilot study: Qualia Mind: Neurohacker Collective
• Use of 'smart drugs' on the rise

Study Officials

• Rupal Trivedi, MD

  Great Lakes Clinical Trials LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 15, 2020
• Study Start: May 12, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)