Status:
COMPLETED
Safety and Efficacy Study of Qualia Mind on Cognition in a Healthy Population
Lead Sponsor:
Neurohacker Collective
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Healthy
Cognitive Function
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04389723
Start Date
May 12 2020
End Date
September 15 2020
Last Update
October 9 2020
Active Locations (1)
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1
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640