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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Virtiva® Plus, a supplement, to determine how different doses affect stress and cognitive performance in individuals experiencing high stress levels. Participants will receive either a low dose or a high dose daily for five weeks. Researchers aim to identify any side effects from the supplement. Individuals aged 50 to 70 who feel stressed and can avoid other cognitive supplements may be suitable for this study. As an unphased trial, this study allows participants to contribute to early-stage research and potentially benefit from a novel approach to managing stress.

Do I have to stop taking my current medications for the trial?

The trial requires participants to stop taking any cognitive enhancement supplements 7 days before and during the study. However, it does not specify if you need to stop other medications, so it's best to discuss this with the trial team.

Is there any evidence suggesting that Virtiva® Plus is likely to be safe for humans?

Research shows that Virtiva® Plus, containing Ginkgo biloba extract and phosphatidylserine, has been used safely to improve mental functions like memory and attention. Ginkgo biloba extract, a main ingredient, has been studied in real-life situations and generally appears safe, with few reports of side effects. Some studies have not found significant negative effects from using this extract.

However, data collection on the combination of ingredients in Virtiva® Plus continues. The current study closely monitors any side effects over a five-week period. As this treatment is in the early stages of research, safety information is still being confirmed. Always consult a healthcare provider to understand the potential risks and benefits based on personal health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Virtiva Plus is unique because it combines Ginkgo biloba extract with phosphatidylserine to potentially reduce stress. Unlike standard stress treatments that often involve medications like SSRIs or benzodiazepines, which can have various side effects, Virtiva Plus uses natural ingredients that are believed to support brain health and improve cognitive function. Researchers are particularly excited about the two dosing options, which provide flexibility in managing stress levels with either a low or high dose, catering to individual needs. This combination and dosing flexibility might offer a more natural and tailored approach to stress management compared to conventional medications.

What evidence suggests that Virtiva® Plus might be an effective treatment for stress?

Research suggests that Virtiva® Plus, which contains Ginkgo biloba extract and phosphatidylserine, may help reduce stress. Studies have shown that Ginkgo biloba can lower cortisol levels, a hormone released during stress, in healthy individuals. Another study indicated that this combination can improve memory, particularly working memory and the speed of information recall. These findings suggest that Virtiva® Plus might benefit those dealing with stress and seeking cognitive improvements. While the current data is promising, more research is needed to fully understand its effects.

In this trial, participants will receive either a low dose or a high dose of Virtiva® Plus to evaluate its effectiveness in reducing stress and enhancing cognitive function. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06583941?term=GINKGO%20BILOBA%20LEAF&rank=9

Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on ...

This is a randomized, double-blind, 5-week intervention clinical study that aims to investigate the dose-dependent effects of Virtiva® Plus on stress, ...

2.

researchgate.net

researchgate.net/publication/307518507_Effects_of_standardized_Ginkgo_biloba_extract_complexed_with_phosphatidylserine_VirtivaR_on_physiological_response_to_prolonged_intense_physical_activity

Effects of standardized Ginkgo biloba extract complexed ...

CONCLUSIONS: Our study suggests that administration of standardized GBE combined with phosphatidylserine (Virtiva®) might exert a beneficial effect on athletes ...

3.

ctv.veeva.com

ctv.veeva.com/study/effects-of-indenas-virtiva-r-plus-ginkgo-biloba-extract-on-stress-and-cognitive-performance

Effects of Indena's Virtiva® Plus Ginkgo Biloba Extract on ...

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 ...

4.

researchgate.net

researchgate.net/profile/Stefano-Togni/publication/307518507_Effects_of_standardized_Ginkgo_biloba_extract_complexed_with_phosphatidylserine_VirtivaR_on_physiological_response_to_prolonged_intense_physical_activity/links/57cfe7fb08ae83b3746429b0/Effects-of-standardized-Ginkgo-biloba-extract-complexed-with-phosphatidylserine-VirtivaR-on-physiological-response-to-prolonged-intense-physical-activity.pdf?origin=scientificContributions

Effects-of-standardized-Ginkgo-biloba-extract-complexed- ...

BACKGROUND: Previous studies demonstrated that administration of standardized extract of Ginkgo biloba reduces stress-induced cortisol increase in young healthy ...

5.

indena.com

indena.com/us/product/virtiva/

Virtiva® Plus

Virtiva Plus supports memory processes, particularly working memory and memory consolidation, and it optimizes memory speed.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39476880/

Ginkgo biloba extract safety: Insights from a real-world ...

Limited data exist regarding adverse drug reactions associated with Ginkgo biloba extract post-marketing. Aim of the study: Currently, the drug ...

7.

withpower.com

withpower.com/trial/phase-stress-psychology-8-2024-35d6d

Virtiva Plus for Stress · Info for Participants

This is a randomized, double-blind, 5-week intervention clinical study that aims to investigate the dose-dependent effects of Virtiva® Plus on stress, ...