Mental ProcessesNCT06309914
The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States
A study testing Enovita Grape Seed Extract, Mirtoselect Bilberry Extract and Virtiva Plus Ginko Biloba Extract in people with Mental Processes and Cognitive Change, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Processes, Cognitive Change, Mood Change
- What is being tested?
- Enovita Grape Seed Extract, Mirtoselect Bilberry Extract and Virtiva Plus Ginko Biloba Extract
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Science and Performance Institute
Tampa, Florida, 33607
About this study
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
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.
Read the 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.
- Conditions
- Mental Processes, Cognitive Change, Mood Change
- Being tested
- Placebo, Enovita Grape Seed Extract, Mirtoselect Bilberry Extract, Virtiva Plus Ginko Biloba Extract
- Keywords
- Bilberry Extract, Ginkgo Biloba Extract, Grape Seed Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects will consume one capsule of the Placebo twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.
Enovita Grape Seed ExtractDietary supplement
Subjects will consume one capsule of Enovita twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.
Mirtoselect Bilberry ExtractDietary supplement
Subjects will consume one capsule of Mirtoselect twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.
Virtiva Plus Ginko Biloba ExtractDietary supplement
Subjects will consume one capsule of Virtiva Plus twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | One dose (1 capsule) will be consumed twice daily for 28 days. The placebo product will be rice flour (other ingredients: hypromellose, magnesium stearate and chlorophyll). Its appearance will be green/green oblong veggie capsule with white to off-white powder fill. Receives: Dietary Supplement: Placebo |
| Enovita Dietary Supplement | Experimental | One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 150mg grape seed extract (Vitis vinifera L) and dried seed (cultivated), and 27.50mg 95% polyphenols. Receives: Dietary Supplement: Enovita Grape Seed Extract |
| Mirtoselect Dietary Supplement | Experimental | One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 160mg bilberry extract (Vaccinium myrtillus L.) and 57.6mg 36% anthocyanosides. Receives: Dietary Supplement: Mirtoselect Bilberry Extract |
| Virtiva Dietary Supplement | Experimental | One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 240mg Ginkgo biloba extract (leaf), 28.8mg 12% phosphatidylserine (from sunflower), and 12mg 5% ginkgo flavonglycosides. Receives: Dietary Supplement: Virtiva Plus Ginko Biloba Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Memory
The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations.
Measured: Baseline, Day 28
Change in Verbal Memory
The verbal memory test measures how well a subject can recognize, remember, and retrieve words.
Measured: Baseline, Day 28
Change in Finger Tapping Test (FTT) Results
The FTT measures the speed and number of finger-taps on each hand. This tests the motor speed and fine motor capability of subjects.
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Change in Symbol Digit Coding (SDC) Test Results
Measures the speed of processing while drawing upon several cognitive processes simultaneously (i.e., visual scanning, visual perception, visual memory, and motor functions).
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Change in Stroop Test Results
Assesses the ability to inhibit cognitive interference that occurs when the processing of a stimulus impedes the simultaneous processing of a second stimulus.
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Change in Shifting Attention Test Results
Measures a subject's executive function (i.e., rules, categories, decision making) or their ability to shift from one instruction set to another quickly and accurately.
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Change in Continuous Performance Test Results
Measures vigilance or sustained attention over time.
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Secondary outcomes (1)
Change in Abbreviated Profile of Mood States (POMS) Score
Changes assessed in the abbreviated profile of mood states for subjective assessment of the subject's mood and overall well-being. It is a 40 point scale, divided into 7 different subscales, with a 5 point Likert scale, ranging from 0 (not at all) to 4 (Extremely) of how a subject feels in response to that particular feeling. The following equation is used to determine the overall score: Total Mood Disturbance = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem Related Affect]. A lower score indicates overall better mood, while a lower score indicates worse overall mood
Measured: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on day 0, and Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start21 Feb 2024
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Wilson, Ph.D., Principal investigator, The Applied Science and Performance Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309914
- Sponsor's protocol ID
- Pro00074459
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06309914
- Acronym / sponsor ID
- Pro00074459
- Conditions
- Mental Processes, Cognitive Change, Mood Change
- Keywords
- Bilberry Extract, Ginkgo Biloba Extract, Grape Seed Extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne dose (1 capsule) will be consumed twice daily for 28 days. The placebo product will be rice flour (other ingredients: hypromellose, magnesium stearate and chlorophyll). Its appearance will be green/green oblong veggie capsule with white to off-white powder fill. |
| Enovita Dietary Supplement | Experimental | Dietary Supplement: Enovita Grape Seed ExtractOne dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 150mg grape seed extract (Vitis vinifera L) and dried seed (cultivated), and 27.50mg 95% polyphenols. |
| Mirtoselect Dietary Supplement | Experimental | Dietary Supplement: Mirtoselect Bilberry ExtractOne dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 160mg bilberry extract (Vaccinium myrtillus L.) and 57.6mg 36% anthocyanosides. |
| Virtiva Dietary Supplement | Experimental | Dietary Supplement: Virtiva Plus Ginko Biloba ExtractOne dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 240mg Ginkgo biloba extract (leaf), 28.8mg 12% phosphatidylserine (from sunflower), and 12mg 5% ginkgo flavonglycosides. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSubjects will consume one capsule of the Placebo twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS. | Dietary supplement | Placebo |
| Enovita Grape Seed ExtractSubjects will consume one capsule of Enovita twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS. | Dietary supplement | Enovita Dietary Supplement |
| Mirtoselect Bilberry ExtractSubjects will consume one capsule of Mirtoselect twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS. | Dietary supplement | Mirtoselect Dietary Supplement |
| Virtiva Plus Ginko Biloba ExtractSubjects will consume one capsule of Virtiva Plus twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. 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. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then 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). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS. | Dietary supplement | Virtiva Dietary Supplement |
Primary outcome
Change in Visual Memory
Time frame: Baseline, Day 28
The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations.
Change in Verbal Memory
Time frame: Baseline, Day 28
The verbal memory test measures how well a subject can recognize, remember, and retrieve words.
Change in Finger Tapping Test (FTT) Results
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
The FTT measures the speed and number of finger-taps on each hand. This tests the motor speed and fine motor capability of subjects.
Change in Symbol Digit Coding (SDC) Test Results
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Measures the speed of processing while drawing upon several cognitive processes simultaneously (i.e., visual scanning, visual perception, visual memory, and motor functions).
Change in Stroop Test Results
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Assesses the ability to inhibit cognitive interference that occurs when the processing of a stimulus impedes the simultaneous processing of a second stimulus.
Change in Shifting Attention Test Results
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Measures a subject's executive function (i.e., rules, categories, decision making) or their ability to shift from one instruction set to another quickly and accurately.
Change in Continuous Performance Test Results
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Measures vigilance or sustained attention over time.
1 secondary outcome
Change in Abbreviated Profile of Mood States (POMS) Score
Time frame: Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on day 0, and Day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Wilson, Ph.D. principal investigator
The Applied Science and Performance Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enovita Grape Seed Extract, Mirtoselect Bilberry Extract and Virtiva Plus Ginko Biloba Extract in people with Mental Processes and Cognitive Change, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Memory (time frame: Baseline, Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.