The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States

Summary

This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 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 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups.

Conditions

• Mental Processes
• Cognitive Change
• Mood Change

Interventions

DIETARY_SUPPLEMENT

Placebo

Subjects will consume one capsule of the Placebo twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (\~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. Immediately after, subjects will consume two capsules of their randomly assigned study product. At 60 minutes post-consumption, subjects will repeat the computerized cognitive assessment. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then be instructed to continue to take their respective study product twice daily, one capsule with the first meal of the day and one capsule with the evening meal, for the duration of the supplementation period (28 days). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.

DIETARY_SUPPLEMENT

Enovita Grape Seed Extract

Subjects will consume one capsule of Enovita twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (\~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. Immediately after, subjects will consume two capsules of their randomly assigned study product. At 60 minutes post-consumption, subjects will repeat the computerized cognitive assessment. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then be instructed to continue to take their respective study product twice daily, one capsule with the first meal of the day and one capsule with the evening meal, for the duration of the supplementation period (28 days). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.

DIETARY_SUPPLEMENT

Mirtoselect Bilberry Extract

Subjects will consume one capsule of Mirtoselect twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (\~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. Immediately after, subjects will consume two capsules of their randomly assigned study product. At 60 minutes post-consumption, subjects will repeat the computerized cognitive assessment. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then be instructed to continue to take their respective study product twice daily, one capsule with the first meal of the day and one capsule with the evening meal, for the duration of the supplementation period (28 days). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.

DIETARY_SUPPLEMENT

Virtiva Plus Ginko Biloba Extract

Subjects will consume one capsule of Virtiva Plus twice daily for 28 days. At Day 0, they will perform the full cognitive assessment (\~45 minutes) and complete the abbreviated POMS questionnaire in a fasted state. Immediately after, subjects will consume two capsules of their randomly assigned study product. At 60 minutes post-consumption, subjects will repeat the computerized cognitive assessment. At 180 minutes post-consumption, subjects will repeat the computerized cognitive assessment and abbreviated POMS questionnaire. Subjects will then be instructed to continue to take their respective study product twice daily, one capsule with the first meal of the day and one capsule with the evening meal, for the duration of the supplementation period (28 days). After 28 days of supplementation, subjects will be reassessed on the computerized cognitive assessment and abbreviated POMS.

Sponsors & Collaborators

• Applied Science & Performance Institute

  lead INDUSTRY

Principal Investigators

• Jacob Wilson, Ph.D. · The Applied Science and Performance Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-21

Primary Completion

2024-07-08

Completion

2024-07-08

Countries

• United States

Study Locations