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

Applied Science & Performance Institute60 enrolled

Overview

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.

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.

Interventions

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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.