StressNCT06583941
Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance
A study testing Low Dose Virtiva Plus and High Dose Virtiva Plus in people with Stress and Mood, run by Applied Science & Performance Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Mood, Cognitive Change
- What is being tested?
- Low Dose Virtiva Plus and High Dose Virtiva Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2025to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 50 to 70 years (both limits inclusive)
- Body mass index (BMI) value of 18.5-29.99 kg/m2
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
- Able and willing to comply with the schedule visit(s) and study requirements.
Show all 9Show fewer
- Willing to consume the investigational study product 2 times per day for 5 weeks.
- Willing to maintain a habitual diet and avoid changes during the study period (for example, intermittent fasting, ketogenic diet, Atkins diet, meatless diet, etc.).
- Willing to cease from consuming cognitive enhancement supplements 7 days prior to and after the study commencement, until the end of the study.
Who cannot join
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
- History of cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- History of neurological disorders (Parkinson's, Amyotrophic lateral sclerosis, epilepsy, spinal cord injury resulting in inability to use upper extremities, other)
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History of kidney or liver disease
- History of metabolic disorders (diabetes, metabolic syndrome, other)
Show all 14Show fewer
- History or current malignancy
- Receiving chemotherapy agents or radiation treatments
- Diagnosis of a terminal illness
- Pregnancy or has breast fed within 3 months prior to enrollment
- Use of prescription medications that impact digestion (i.e., proton pump inhibitor medications, other)
- History or current alcohol or drug abuse
- Has significant concurrent illnesses (controlled or uncontrolled), such as lupus, hepatitis B/C, HIV, serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years, or other, which in the opinion of the investigator, such condition might be aggravated as a result of treatment
- The investigator feels that for any reason the subject is not eligible to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Applied Science and Performance Institute
Tampa, Florida, 33634
About this study
Official title: The Dose-Response Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance in Participants Experiencing Heightened Stress
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.
Read the 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
- Being tested
- Low Dose Virtiva Plus, High Dose Virtiva Plus
- Keywords
- Ginkgo Biloba Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose Virtiva PlusDietary supplement
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.
High Dose Virtiva PlusDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Virtiva Plus | Experimental | One dose (1 capsule) of Virtiva Plus will be consumed twice daily for up to 5 weeks. A single dose contains: 120mg Ginkgo biloba extract (leaf), a minimum of 14.4mg phosphatidylserine, and a minimum of 6mg ginkgo flavonglycosides. Receives: Dietary Supplement: Low Dose Virtiva Plus |
| High Dose Virtiva Plus | Experimental | One dose (1 capsule) of Virtiva Plus will be consumed twice daily for up to 5 weeks. A single dose contains: 240mg Ginkgo biloba extract (leaf), a minimum of 28.8mg phosphatidylserine, and a minimum of 12mg ginkgo flavonglycosides. Receives: Dietary Supplement: High Dose Virtiva Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generalized Anxiety Disorder-7 (GAD7)
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.
Measured: Pre-Event, 5 weeks Post Event
Perceived Stress Scale - 10 (PSS-10)
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
Measured: Pre-Event, 5 weeks Post Event
Short Form 36 (SF-36)
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.
Measured: Pre-Event, 5 weeks Post Event
Satisfaction with Life Scale (SWLS)
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
Measured: Pre-Event, 5 weeks Post Event
Positive emotion, Negative Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA Profiler)
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
Measured: Pre-Event, 5 weeks Post Event
Dysfunctional Attitudes Scale-17 (DAS-17)
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).
Measured: Pre-Event, 5 weeks Post Event
Everyday Cognition 12 Scale (ECog-12)
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).
Measured: 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." 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.
Measured: Pre-Event, 5 weeks Post Event
Secondary outcomes (8)
Visual memory
The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations.
Measured: Pre-Event, 5 weeks Post Event
Verbal Memory
The verbal memory test measures how well a subject can recognize, remember, and retrieve words.
Measured: Pre-Event, 5 weeks Post Event
Finger Tapping Test (FTT)
The FTT measures the speed and number of finger-taps on each hand.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-Event, 5 weeks Post Event
Continuous Performance Test
Measures vigilance or sustained attention over time.
Measured: 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.
Measured: Pre-Event, 5 weeks Post Event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start10 Jan 2025
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science & Performance Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583941
- Sponsor's protocol ID
- IND072924
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose-Response Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance in Participants Experiencing Heightened Stress
- ClinicalTrials.gov ID
- NCT06583941
- Acronym / sponsor ID
- IND072924
- Conditions
- Stress, Mood, Cognitive Change
- Keywords
- Ginkgo Biloba Extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Applied Science & Performance InstituteIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Virtiva Plus | Experimental | Dietary Supplement: Low Dose Virtiva PlusOne dose (1 capsule) of Virtiva Plus will be consumed twice daily for up to 5 weeks. A single dose contains: 120mg Ginkgo biloba extract (leaf), a minimum of 14.4mg phosphatidylserine, and a minimum of 6mg ginkgo flavonglycosides. |
| High Dose Virtiva Plus | Experimental | Dietary Supplement: High Dose Virtiva PlusOne dose (1 capsule) of Virtiva Plus will be consumed twice daily for up to 5 weeks. A single dose contains: 240mg Ginkgo biloba extract (leaf), a minimum of 28.8mg phosphatidylserine, and a minimum of 12mg ginkgo flavonglycosides. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female
- Aged 50 to 70 years (both limits inclusive)
- Body mass index (BMI) value of 18.5-29.99 kg/m2
- Willing and able to give written informed consent
- Able to read, understand, sign and date the informed consent document (English only)
Key exclusion criteria (14 listed)
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements.
- History of cardiovascular disease (i.e., myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other)
- History of neurological disorders (Parkinson's, Amyotrophic lateral sclerosis, epilepsy, spinal cord injury resulting in inability to use upper extremities, other)
- History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements, (i.e., inflammatory bowel disease, ulcerative colitis, Crohn's disease, colostomy, or eating disorder)
- History of kidney or liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose Virtiva PlusParticipants 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 | Low Dose Virtiva Plus |
| High Dose Virtiva PlusParticipants 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. | Dietary supplement | High Dose Virtiva Plus |
Primary outcome
Generalized Anxiety Disorder-7 (GAD7)
Time frame: 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.
Perceived Stress Scale - 10 (PSS-10)
Time frame: 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
Short Form 36 (SF-36)
Time frame: 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.
Satisfaction with Life Scale (SWLS)
Time frame: 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
Positive emotion, Negative Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA Profiler)
Time frame: 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
Dysfunctional Attitudes Scale-17 (DAS-17)
Time frame: 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).
Everyday Cognition 12 Scale (ECog-12)
Time frame: 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).
Abbreviated Profile of Mood States (POMS)
Time frame: 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.
8 secondary outcomes
Visual memory
Time frame: Pre-Event, 5 weeks Post Event
Verbal Memory
Time frame: Pre-Event, 5 weeks Post Event
Finger Tapping Test (FTT)
Time frame: Pre-Event, 5 weeks Post Event
Symbol Digit Coding (SDC)
Time frame: Pre-Event, 5 weeks Post Event
Stroop Test
Time frame: Pre-Event, 5 weeks Post Event
Shifting Attention
Time frame: Pre-Event, 5 weeks Post Event
Continuous Performance Test
Time frame: Pre-Event, 5 weeks Post Event
4-Part Continuous Performance Test (4PCPT)
Time frame: Pre-Event, 5 weeks Post Event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose Virtiva Plus and High Dose Virtiva Plus in people with Stress and Mood, run by Applied Science & Performance Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder-7 (GAD7) (time frame: Pre-Event, 5 weeks Post Event). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.