Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06309914 |
| Other study ID # |
Pro00074459 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 21, 2024 |
| Est. completion date |
July 22, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Applied Science & Performance Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| 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.
