Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309914
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-03-07
Brief Title:
The Effects of Mirtoselect Virtiva and Enovita on Cognitive Performance and Mood States
Sponsor:
Applied Science Performance Institute
Organization:
Applied Science Performance Institute
Study Overview
Official Title:
The Effects of Indenas Mirtoselect Bilberry Extract Virtiva Ginkgo Biloba Extract and Enovita Grape Seed Extract on Cognitive Performance and Mood States Over a 4-week Time Course
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-screeningenrollment Day -30 to Day -1 The potential subject will present a health history questionnaire to screen for study eligibility described in sections 521 inclusion criteria and 522 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 NoID 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
Event 1 - Pre-screeningenrollment Day -30 to Day -1 The potential subject will present a health history questionnaire to screen for study eligibility described in sections 521 inclusion criteria and 522 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 NoID 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None