Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583941
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
Effects of Indenas Virtiva Plus Ginkgo Biloba Extract on Stress and Cognitive Performance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Dose-Response Effects of Indenas Virtiva Plus Ginkgo Biloba Extract on Stress and Cognitive Performance in Participants Experiencing Heightened Stress
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind 5-week intervention clinical study that aims to investigate the dose-dependent effects of Virtiva Plus on stress and cognitive performance in participants experiencing heightened stress The occurrence of adverse events in response to daily supplementation of Virtiva Plus will also be measured The desired sample size for this study is 24 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 29 subjects Subjects will be randomly divided into two study groups low dose 240 mgday or high dose 480 mgday of Virtiva Plus For both groups the dose will be divided into two equal servings Blocked randomization will be deployed in which subjects are divided into blocks of 2 subjects and each subject within a block is randomly assigned to one of the two study groups Participants will be asked to stop taking alternative supplements used for cognitive enhancement 7 days prior to study related cognitive testing assessments
Detailed Description:
Enrollment Week -4 to Week -3 After obtaining written informed consent participants will undergo screening to ensure they are free of cardiovascular- neurological- hepatic- renal- metabolic diseases which will be determined by health history questionnaire Additionally as part of screening participants will be required to have a total Perceived Stress Scale PSS score 13 and 27 for moderate stress If they pass the screening tests they will be given a battery of cognitive assessment tests as part of a familiarizationacquisition phase of testing on a separate day
Familiarizationacquisition phase with computerized cognitive testing Week -2 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 After completion of the familiarization procedures subjects will be randomly assigned to one of two study groups Virtiva Plus 240 mgday or Virtiva Plus 480 mgday and will be assigned a subject NoID in the 100 series starting with 101 and continuing in sequential order until enrollment is met
Baseline Testing Week -1 Day -7 to Day -1 Prior to receiving their first study treatment participants will undergo baseline assessments on all study variables Baseline testing will occur within 7 days of being assigned to their study group On Day -7 participants will consume a normal breakfast caffeine and stimulant-free and undertake a cognitive battery of tests lasting 30 min 3-hours post-breakfast see these tests under Secondary Endpoints On Day -6 participants will again consume a normal breakfast and take multiple survey questionnaires 3-hours post-breakfast see these tests under Primary Endpoints Between Days -5 to -1 participants will repeat the survey tests in identical manner on two additional days for a total of three survey tests taken The average score of the three survey tests will be used for analysis The tests may be taken on consecutive days
Study Treatments Day 1 to Day 35 Participants will be instructed to start their study treatments on Day 1 and continue supplementation for 353 days
Endpoint Cognitive Tests Week 4 Days 26 to 28 Participants will take one serving of their treatment 120 or 240 mg of Virtiva Plus with a normal meal Three hours later participants will complete all cognitive tests described under the Secondary Endpoints section These cognitive tests will only be taken on one occasion during these three days Days 26 to 28
Endpoint Survey Tests Week 5 Days 29 to 35 On three separate occasions between Day 29 to Day 35 participants will consume a normal breakfast caffeine and stimulant-free plus one serving of their treatment 120 or 240 mg of Virtiva Plus Three hours post breakfast participants will complete all survey questionnaires described in the Primary Endpoints section on three separate occasions The average score of the three survey tests will be used for analysis The tests may be taken on consecutive days
Familiarizationacquisition phase with computerized cognitive testing Week -2 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 After completion of the familiarization procedures subjects will be randomly assigned to one of two study groups Virtiva Plus 240 mgday or Virtiva Plus 480 mgday and will be assigned a subject NoID in the 100 series starting with 101 and continuing in sequential order until enrollment is met
Baseline Testing Week -1 Day -7 to Day -1 Prior to receiving their first study treatment participants will undergo baseline assessments on all study variables Baseline testing will occur within 7 days of being assigned to their study group On Day -7 participants will consume a normal breakfast caffeine and stimulant-free and undertake a cognitive battery of tests lasting 30 min 3-hours post-breakfast see these tests under Secondary Endpoints On Day -6 participants will again consume a normal breakfast and take multiple survey questionnaires 3-hours post-breakfast see these tests under Primary Endpoints Between Days -5 to -1 participants will repeat the survey tests in identical manner on two additional days for a total of three survey tests taken The average score of the three survey tests will be used for analysis The tests may be taken on consecutive days
Study Treatments Day 1 to Day 35 Participants will be instructed to start their study treatments on Day 1 and continue supplementation for 353 days
Endpoint Cognitive Tests Week 4 Days 26 to 28 Participants will take one serving of their treatment 120 or 240 mg of Virtiva Plus with a normal meal Three hours later participants will complete all cognitive tests described under the Secondary Endpoints section These cognitive tests will only be taken on one occasion during these three days Days 26 to 28
Endpoint Survey Tests Week 5 Days 29 to 35 On three separate occasions between Day 29 to Day 35 participants will consume a normal breakfast caffeine and stimulant-free plus one serving of their treatment 120 or 240 mg of Virtiva Plus Three hours post breakfast participants will complete all survey questionnaires described in the Primary Endpoints section on three separate occasions The average score of the three survey tests will be used for analysis The tests may be taken on consecutive days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None