Virtiva Plus for Stress

Overseen By Jacob Wilson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Applied Science & Performance Institute

Must not be taking: Proton pump inhibitors

Disqualifiers: Cardiovascular, Neurological, Gastrointestinal, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 5 weeks

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for men and women aged 50-70 with a BMI of 18.5-29.99, willing to take Virtiva® Plus twice daily for 5 weeks and avoid diet changes or other cognitive supplements during the study. Participants must understand English, consent in writing, and follow the study schedule.

Inclusion Criteria

Able to read, understand, sign and date the informed consent document (English only)

I am between 50 and 70 years old.

Body mass index (BMI) value of 18.5-29.99 kg/m2

Exclusion Criteria

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

I have a history of neurological disorders like Parkinson's or epilepsy.

Diagnosis of a terminal illness

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Familiarization/Acquisition

Participants undergo an abbreviated version of computerized cognitive testing to familiarize with the online platform and testing instructions.

1 week

1 visit (in-person)

Baseline Testing

Participants undergo baseline assessments on all study variables, including cognitive and survey tests.

1 week

Multiple visits (in-person)

Treatment

Participants receive either low or high dose of Virtiva® Plus for 5 weeks.

5 weeks

Regular visits (in-person)

Endpoint Cognitive and Survey Tests

Participants complete endpoint cognitive and survey tests to assess the effects of the treatment.

1 week

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

Treatment Details

Interventions

• Virtiva® Plus

Trial Overview The trial tests low (240 mg/day) versus high (480 mg/day) doses of Virtiva® Plus on stress and cognitive performance over five weeks in stressed individuals. It's randomized and double-blind, meaning neither researchers nor participants know who gets which dose.

Participant Groups

Group I: Low Dose Virtiva Plus Experimental Treatment 1 Intervention

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.

Group II: High Dose Virtiva Plus Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Applied Science & Performance Institute

Lead Sponsor

Trials

17

Recruited

1,200+