NCT06583941

Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance

The Dose-Response Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance in Participants Experiencing Heightened Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Applied Science & Performance Institute · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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 mg/day) or high dose (480 mg/day) 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 familiarization/acquisition phase of testing on a separate day. Familiarization/acquisition 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 mg/day or Virtiva® Plus 480 mg/day and will be assigned a subject No./ID 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 35+3 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.

Conditions

• Stress
• Mood
• Cognitive Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low Dose Virtiva Plus	Participants will consume a low dose of Virtiva Plus (120mg) twice daily, for 5 weeks. Prior to receiving their first study treatment, participants will undergo baseline assessments on all study variables. Including computerized cognitive assessment and survey questionnaires. After 4 weeks of supplementation, participants will take one serving of their treatment (120mg of Virtiva Plus) with a normal meal. Three hours later, participants will complete cognitive tests. On a separate day, the same procedure will be repeated, and subjects will take the survey tests.
DIETARY_SUPPLEMENT	High Dose Virtiva Plus	Participants will consume a high dose of Virtiva Plus (240mg) twice daily, for 5 weeks. Prior to receiving their first study treatment, participants will undergo baseline assessments on all study variables. Including computerized cognitive assessment and survey questionnaires. After 4 weeks of supplementation, participants will take one serving of their treatment (240mg of Virtiva Plus) with a normal meal. Three hours later, participants will complete cognitive tests. On a separate day, the same procedure will be repeated, and subjects will take the survey tests.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2024-09-04
• Last updated: 2025-09-16

Locations

1 site across 1 country: United States