Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance
NCT06583941, Not applicable, Completed, Applied Science & Performance Institute
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance | ClinicalTrials.gov |
| NCT number | NCT06583941 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Applied Science & Performance Institute | ClinicalTrials.gov |
| Conditions | Stress, Mood, Cognitive Change | ClinicalTrials.gov |
| Interventions | Low Dose Virtiva Plus, High Dose Virtiva Plus | ClinicalTrials.gov |
| First posted | 2024-09-04 | ClinicalTrials.gov |
| Last updated | 2025-09-16 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Generalized Anxiety Disorder-7 (GAD7) | Pre-Event, 5 weeks Post Event | The Generalized Anxiety Disorder-7 (GAD-7) is a brief, self-administered screening tool designed to identify probable cases of generalized anxiety disorder and assess its severity in both clinical and research settings. The GAD-7 consists of seven items, each reflecting core symptoms of generalized anxiety disorder as outlined in the Diagnostic and Statistical Manual of Mental Disorders. Respondents rate the frequency of these symptoms over the past two weeks on a 4-point Likert scale, ranging from not at all (0) to nearly every day (3). The total score, which ranges from 0 to 21, provides an indication of the severity of anxiety symptoms, with higher scores corresponding to greater symptom severity. The GAD-7 has demonstrated good reliability and validity across diverse populations. | ClinicalTrials.gov |
| Primary | Perceived Stress Scale - 10 (PSS-10) | Pre-Event, 5 weeks Post Event | The Perceived Stress Scale is 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. The PSS-10 contains a number of direct queries about current levels of experienced stress. Participants responded to questions on a scale ranging from 0 (never) to 4 (very often), with a higher score indicating more perceived stress | ClinicalTrials.gov |
| Primary | Short Form 36 (SF-36) | Pre-Event, 5 weeks Post Event | The SF-36 is a questionnaire that measures health-related quality of life. Component analyses showed that there are two distinct concepts measured in the questionnaire - a physical component and a mental dimension. 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 Question responses range from 1 to 5 or from 1 to 6 and each response is converted to a score from 0 to 100. For all questions, higher scores demonstrated greater well-being. | ClinicalTrials.gov |
| Primary | Satisfaction with Life Scale (SWLS) | Pre-Event, 5 weeks Post Event | The Satisfaction with Life Scale (SWLS) is a widely used self-report instrument designed to measure an individual\'s global cognitive judgments of their life satisfaction. Developed by Diener, Emmons, Larsen, and Griffin in 1985, the SWLS consists of five items, each rated on a 7-point Likert scale ranging from \"strongly disagree\" (1) to \"strongly agree\" (7). The total score, ranging from 5 to 35, reflects overall life satisfaction, with higher scores indicating greater satisfaction | ClinicalTrials.gov |
| Primary | Positive emotion, Negative Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA Profiler) | Pre-Event, 5 weeks Post Event | The PERMA Profiler is 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. The profiler consists of 23 items, with respondents rating their experiences on an 11-point Likert scale, ranging from \"never\" (0) to \"always\" (10). The PERMA Profiler also includes items assessing overall well-being, negative emotion, and physical health. This multidimensional approach allows for a nuanced understanding of well-being, capturing both hedonic and eudaimonic aspects | ClinicalTrials.gov |
| Primary | Dysfunctional Attitudes Scale-17 (DAS-17) | Pre-Event, 5 weeks Post Event | The Dysfunctional Attitudes Scale-17 (DAS-17) is 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 was designed to measure cognitive vulnerability to depression. Respondents rate each item on a 7-point Likert scale, ranging from \"totally agree\" to \"totally disagree.\" The DAS-17 focuses on two primary dimensions: perfectionism/performance evaluation and dependency/need for approval. Higher scores on the DAS-17 indicate a greater endorsement of dysfunctional attitudes (Power \& Dalgleish, 1997). | ClinicalTrials.gov |
| Primary | Everyday Cognition 12 Scale (ECog-12) | Pre-Event, 5 weeks Post Event | The Everyday Cognition 12 Scale (ECog-12) is a brief, informant-rated assessment tool designed to measure everyday cognitive function in older adults. Derived from the longer Everyday Cognition (ECog) scale, the ECog-12 focuses on evaluating changes in cognitive abilities that occur in everyday life across multiple domains, including memory, language, visuospatial abilities, planning, organization, and divided attention. Informants rate each of the 12 items based on the observed frequency of cognitive difficulties over the past 10 years, using a 4-point Likert scale ranging from \"no change\" (1) to \"a lot more frequently\" (4). The ECog-12 is used in both clinical and research settings to detect early cognitive decline and monitor changes over time (Farias et al., 2008). | ClinicalTrials.gov |
| Primary | Abbreviated Profile of Mood States (POMS) | Pre-Event, 5 weeks Post Event | 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." The scores are ranked on a scale of 0 to 4. For instance, if you said you are \"Not at all\" Tense that would score a 0; if you were \"Extremely\" Tense that would rank a 4. Items are combined to form six separate subscales: tension, depression, anger, vigor, fatigue, and confusion. The subscale scores are then combined to form an overall measure of affect that is labeled as total mood disturbance (TMD). A lower score indicates lower mood disturbance, while a higher score indicates increased mood disturbance. | ClinicalTrials.gov |
| Secondary | Visual memory | Pre-Event, 5 weeks Post Event | The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations. | ClinicalTrials.gov |
| Secondary | Verbal Memory | Pre-Event, 5 weeks Post Event | The verbal memory test measures how well a subject can recognize, remember, and retrieve words. | ClinicalTrials.gov |
| Secondary | Finger Tapping Test (FTT) | Pre-Event, 5 weeks Post Event | The FTT measures the speed and number of finger-taps on each hand. | ClinicalTrials.gov |
| Secondary | Symbol Digit Coding (SDC) | Pre-Event, 5 weeks Post Event | Measures the speed of processing while drawing upon several cognitive processes simultaneously (i.e., visual scanning, visual perception, visual memory, and motor functions). | ClinicalTrials.gov |
| Secondary | Stroop Test | Pre-Event, 5 weeks Post Event | Assesses the ability to inhibit cognitive interference that occurs when the processing of a stimulus impedes the simultaneous processing of a second stimulus. | ClinicalTrials.gov |
| Secondary | Shifting Attention | Pre-Event, 5 weeks Post Event | 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. | ClinicalTrials.gov |
| Secondary | Continuous Performance Test | Pre-Event, 5 weeks Post Event | Measures vigilance or sustained attention over time. | ClinicalTrials.gov |
| Secondary | 4-Part Continuous Performance Test (4PCPT) | Pre-Event, 5 weeks Post Event | The 4PCPT test is a four-part test that measures a participant's working memory and sustained attention. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Finger Tapping Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)