Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance
NCT Number: NCT06583941
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Mood|Cognitive Change
Sponsor: Applied Science & Performance Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 29
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2025-04-01

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.

Primary Outcome Measures: Generalized Anxiety Disorder-7 (GAD7), A brief, self-administered screening tool designed to identify probable cases of generalized anxiety disorder and assess its severity., Pre-Event, 5 weeks Post Event|Perceived Stress Scale - 10 (PSS-10), a 10-item questionnaire that measures a participant's perceived stress and the degree to which situations in the participant's life are appraised as stressful., Pre-Event, 5 weeks Post Event|Short Form 36 (SF-36), a questionnaire that measures health-related quality of life. The questionnaire is arranged into 8 categories assessing well-being: physical functioning, limitations due to physical health, limitations to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health, Pre-Event, 5 weeks Post Event|Satisfaction with Life Scale (SWLS), a self-report instrument designed to measure an individual's global cognitive judgments of their life satisfaction., Pre-Event, 5 weeks Post Event|Positive emotion, Negative Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA Profiler), a comprehensive self-report instrument designed to measure well-being across five key dimensions as outlined in Martin Seligman's PERMA model: Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment., Pre-Event, 5 weeks Post Event|Dysfunctional Attitudes Scale-17 (DAS-17), a self-report instrument used to assess cognitive distortions and maladaptive beliefs that are associated with depression and other psychological disorders. This scale consists of 17 items derived from the original 40-item Dysfunctional Attitudes Scale (DAS), which iss designed to measure cognitive vulnerability to depression., Pre-Event, 5 weeks Post Event|Everyday Cognition 12 Scale (ECog-12), a concise, informant-rated assessment tool designed to evaluate everyday cognitive function in older adults. This scale is a shortened version of the original Everyday Cognition (ECog) scale and focuses on 12 items that assess cognitive abilities in daily life, including memory, language, visuospatial skills, planning, organization, and divided attention., Pre-Event, 5 weeks Post Event|Abbreviated Profile of Mood States (POMS), The abbreviated POMS as used in this study is a 40-item version where participants rate each item on a 5-point Likert scale with anchors ranging between "Not at all" to "Extremely." Items are combined to form six separate subscales: tension, depression, anger, vigor, fatigue, and confusion., Pre-Event, 5 weeks Post Event
Secondary Outcome Measures: Visual memory, The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations., Pre-Event, 5 weeks Post Event|Verbal Memory, The verbal memory test measures how well a subject can recognize, remember, and retrieve words., Pre-Event, 5 weeks Post Event|Finger Tapping Test (FTT), The FTT measures the speed and number of finger-taps on each hand., Pre-Event, 5 weeks Post Event|Symbol Digit Coding (SDC), Measures the speed of processing while drawing upon several cognitive processes simultaneously (i.e., visual scanning, visual perception, visual memory, and motor functions)., Pre-Event, 5 weeks Post Event|Stroop Test, Assesses the ability to inhibit cognitive interference that occurs when the processing of a stimulus impedes the simultaneous processing of a second stimulus., Pre-Event, 5 weeks Post Event|Shifting Attention, 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., Pre-Event, 5 weeks Post Event|Continuous Performance Test, Measures vigilance or sustained attention over time., Pre-Event, 5 weeks Post Event|4-Part Continuous Performance Test (4PCPT), The 4PCPT test is a four-part test that measures a participant's working memory and sustained attention., Pre-Event, 5 weeks Post Event