Clinical trial NCT06583941: Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance
Official title: The Dose-Response Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on Stress, and Cognitive Performance in Participants Experiencing Heightened Stress
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Mood
Cognitive Change
Keywords: Ginkgo Biloba Extract
Lead sponsor: Applied Science & Performance Institute
Sponsor class: INDUSTRY
First posted: 2024-09-04
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD7)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Perceived Stress Scale - 10 (PSS-10)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Short Form 36 (SF-36)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Positive emotion, Negative Emotion, Engagement, Relationships, Meaning, and Accomplishment (PERMA Profiler)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Dysfunctional Attitudes Scale-17 (DAS-17)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Everyday Cognition 12 Scale (ECog-12)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Abbreviated Profile of Mood States (POMS)
timeFrame: Pre-Event, 5 weeks Post Event
Secondary outcomes:
measure: Visual memory
timeFrame: Pre-Event, 5 weeks Post Event
measure: Verbal Memory
timeFrame: Pre-Event, 5 weeks Post Event
measure: Finger Tapping Test (FTT)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Symbol Digit Coding (SDC)
timeFrame: Pre-Event, 5 weeks Post Event
measure: Stroop Test
timeFrame: Pre-Event, 5 weeks Post Event
measure: Shifting Attention
timeFrame: Pre-Event, 5 weeks Post Event
measure: Continuous Performance Test
timeFrame: Pre-Event, 5 weeks Post Event
measure: 4-Part Continuous Performance Test (4PCPT)
timeFrame: Pre-Event, 5 weeks Post Event
Other outcomes:
Locations:
city: Tampa
country: United States
facility: The Applied Science and Performance Institute
state: Florida
Study officials:
References: