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

NCT06583941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Low Dose Virtiva Plus

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.

DIETARY_SUPPLEMENT

High Dose Virtiva Plus

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.

Sponsors & Collaborators

  • Applied Science & Performance Institute

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2025-04-04
Completion
2025-04-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06583941 on ClinicalTrials.gov