Clinical trial NCT06309914: The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States
Official title: The Effects of Indena's Mirtoselect® Bilberry Extract, Virtiva® Ginkgo Biloba Extract, and Enovita® Grape Seed Extract on Cognitive Performance and Mood States Over a 4-week Time Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Processes
Cognitive Change
Mood Change
Keywords: Bilberry Extract
Ginkgo Biloba Extract
Grape Seed Extract
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. There are 4 study events for this trial as follow:

Event 1 - Pre-screening/enrollment (Day -30 to Day -1): The potential subject will present a health history questionnaire to screen for study eligibility described in sections 5.2.1 (inclusion criteria) and 5.2.2 (exclusion criteria). The questionnaire will be reviewed by the Investigator or designee, and if the subject is eligible, they will be presented with an IRB approved ICF. The potential subject will be given the opportunity to review the ICF, ask any questions they may have to the Investigator or designee, and will be allowed to take the ICF home for review. The potential subject will be required to sign the ICF for study enrollment to proceed with study participation.

Event 2 - Familiarization with study procedures (computerized cognitive testing, questionnaires, and adverse event report) (Day -7 to Day -1): After obtaining written informed consent form the subject they will be scheduled for familiarization. At familiarization subjects will provide demographic details and will be assessed for anthropometrics (height, weight, body mass index). Subjects will undergo an abbreviated version (\~15 minutes) of the computerized cognitive testing to familiarize with the online platform, testing instructions, and cadence of the tests. Subjects will be shown a clean copy of the abbreviated Profile of Mood States (POMS) questionnaire and the Investigator or designee will describe the questionnaire and provide instructions for completing the questionnaire. The Investigator or designee will explain adverse event reporting and instruct the subject to notify the research staff immediately, or as soon as possible, after the onset of any adverse event. After completion of the familiarization procedures, subjects will be randomly assigned to one of four study groups (Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract) and will be assigned a subject No./ID in the 100 series starting with "101" and continuing in sequential order until enrollment is met.

Event 3 - Baseline assessment (Day 0): In a fasted state, subjects will perform the full computerized cognitive assessment (\~45 minutes) and complete the abbreviated POMS questionnaire (Pre). Immediately after, subjects will consume two capsules of their randomly assigned study product. At 60-minutes post consumption, subjects will repeat the computerized cognitive assessment and will be queried for adverse events. At 180-minutes post consumption, subjects will repeat the computerized cognitive assessment followed by the abbreviated POMS questionnaire, and will be queried for adverse events. The intent of the 60- and 180-minute follow up testing is to investigate potential acute effects of the study products. After the completion of Day 0, subjects will be instructed to continue to take their respective study product twice daily, one capsule with the first meal of the day and one capsule with the evening meal, for the duration of the supplementation period (28 days).

Event 4 - Final Post-Testing (Day 29 to Day 31): After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment, abbreviated POMS, and queried for adverse events. Following these assessments, the subjects will have completed the study.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Memory
timeFrame: Baseline, Day 28
measure: Change in Verbal Memory
timeFrame: Baseline, Day 28
measure: 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.
measure: 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.
measure: Change in Stroop Test Results
timeFrame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
measure: 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.
measure: 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.
Secondary outcomes:
measure: Change in Abbreviated Profile of Mood States (POMS) Score
timeFrame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on day 0, and Day 28.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Applied Science and Performance Institute
state: Florida
Study officials:
affiliation: The Applied Science and Performance Institute
name: Jacob Wilson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: