The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States

Cognitive Change Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309914
• Other study ID #: Pro00074459
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: May 6, 2024

Study information

• Verified date: March 2024
• Source: Applied Science & Performance Institute
• Contact: Justine M Davis, MS
• Phone: 813-673-8888
• Email: jdavis[@]theaspi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: May 6, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Mental Processes
• Mood Change

Intervention

Dietary Supplement:
• Placebo
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 Extract
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 Extract
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 Extract
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.

Locations

Country	Name	City	State
United States	Applied Science and Performance Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science & Performance Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Memory	The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations.	Baseline, Day 28
Primary	Change in Verbal Memory	The verbal memory test measures how well a subject can recognize, remember, and retrieve words.	Baseline, Day 28
Primary	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.	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Primary	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).	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Primary	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.	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Primary	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.	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Primary	Change in Continuous Performance Test Results	Measures vigilance or sustained attention over time.	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.
Secondary	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	Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on day 0, and Day 28.