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

NCT06583941 | Completed

• 1 other identifier: IND072924
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Stress; Mood; Cognitive Change

Keywords

Ginkgo Biloba Extract

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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

  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

  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).

  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).

  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.

  Pre-Event, 5 weeks Post Event

Secondary Outcomes (8)

• Visual memory

  Pre-Event, 5 weeks Post Event

• Verbal Memory

  Pre-Event, 5 weeks Post Event

• Finger Tapping Test (FTT)

  Pre-Event, 5 weeks Post Event

• Symbol Digit Coding (SDC)

  Pre-Event, 5 weeks Post Event

• Stroop Test

  Pre-Event, 5 weeks Post Event

Study Arms (2)

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.

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.

Dietary Supplement: High Dose Virtiva Plus

Interventions

Low Dose Virtiva Plus DIETARY_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.

Low Dose Virtiva Plus

High Dose Virtiva Plus DIETARY_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.

High Dose Virtiva Plus

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

The Applied Science and Performance Institute

Tampa, Florida, 33634, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 4, 2024
• Study Start: January 10, 2025
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)