The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States (NCT06309914) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States
United States76 participantsStarted 2024-02-21
Plain-language summary
This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups.
Who can participate
Age range
25 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 25 to 55 years
* Willing and able to give written informed consent
* Able to read, understand, sign and date the informed consent document (English only)
* Able and willing to comply with the schedule visit(s) and study requirements.
Exclusion Criteria:
* Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
* History of cardiovascular disease
* History of neurological disorders
* History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements
* History of kidney or liver disease
* History of metabolic disorders (diabetes, metabolic syndrome, other)
* History or current malignancy
* Receiving chemotherapy agents or radiation treatments
* Diagnosis of a terminal illness
* Pregnancy or has breastfed within 3 months prior to enrollment
* Use of prescription medications that impact digestion
* History or current alcohol or drug abuse
* Has significant concurrent illnesses (controlled or uncontrolled)
* Participation in any other investigational study within 30 days prior to consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Memory
Timeframe: Baseline, Day 28
2
Change in Verbal Memory
Timeframe: Baseline, Day 28
3
Change in Finger Tapping Test (FTT) Results
Timeframe: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
4
Change in Symbol Digit Coding (SDC) Test Results
Timeframe: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
5
Change in Stroop Test Results
Timeframe: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
6
Change in Shifting Attention Test Results
Timeframe: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
7
Change in Continuous Performance Test Results
Timeframe: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.