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

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy, Cognitive Function

In brief

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.

Key facts

Study ID

NCT04389723

Run by

Neurohacker Collective

People needed

60

Starts

2020-05-12

Expected to finish

2020-09-15

Last updated by the study team

2020-10-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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
• 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

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
• 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)

Where it is running

• Great Lakes Clinical Trials — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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