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

NCT06309914 | Completed

• 1 other identifier: Pro00074459
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bilberry Extract; Ginkgo Biloba Extract; Grape Seed Extract

Outcome Measures

Primary Outcomes (7)

• Change in Visual Memory

  The visual memory test measures how well a subject can recognize, remember, and retrieve geometric figures or spatial representations.

  Baseline, Day 28

• Change in Verbal Memory

  The verbal memory test measures how well a subject can recognize, remember, and retrieve words.

  Baseline, Day 28

• Change in Finger Tapping Test (FTT) Results

  The FTT measures the speed and number of finger-taps on each hand. This tests the motor speed and fine motor capability of subjects.

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.

• Change in Symbol Digit Coding (SDC) Test Results

  Measures the speed of processing while drawing upon several cognitive processes simultaneously (i.e., visual scanning, visual perception, visual memory, and motor functions).

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.

• Change in Stroop Test Results

  Assesses the ability to inhibit cognitive interference that occurs when the processing of a stimulus impedes the simultaneous processing of a second stimulus.

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.

• Change in Shifting Attention Test Results

  Measures a subject's executive function (i.e., rules, categories, decision making) or their ability to shift from one instruction set to another quickly and accurately.

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.

• Change in Continuous Performance Test Results

  Measures vigilance or sustained attention over time.

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on Day 0, and Day 28.

Secondary Outcomes (1)

• Change in Abbreviated Profile of Mood States (POMS) Score

  Baseline, 60 mins post-supplementation on day 0, 180 mins post-supplementation on day 0, and Day 28.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

One dose (1 capsule) will be consumed twice daily for 28 days. The placebo product will be rice flour (other ingredients: hypromellose, magnesium stearate and chlorophyll). Its appearance will be green/green oblong veggie capsule with white to off-white powder fill.

Dietary Supplement: Placebo

Enovita Dietary Supplement

EXPERIMENTAL

One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 150mg grape seed extract (Vitis vinifera L) and dried seed (cultivated), and 27.50mg 95% polyphenols.

Dietary Supplement: Enovita Grape Seed Extract

Mirtoselect Dietary Supplement

EXPERIMENTAL

One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 160mg bilberry extract (Vaccinium myrtillus L.) and 57.6mg 36% anthocyanosides.

Dietary Supplement: Mirtoselect Bilberry Extract

Virtiva Dietary Supplement

EXPERIMENTAL

One dose (1 capsule) will be consumed twice daily for 28 days. A single dose contains: 240mg Ginkgo biloba extract (leaf), 28.8mg 12% phosphatidylserine (from sunflower), and 12mg 5% ginkgo flavonglycosides.

Dietary Supplement: Virtiva Plus Ginko Biloba Extract

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Enovita Grape Seed Extract DIETARY_SUPPLEMENT

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.

Enovita Dietary Supplement

Mirtoselect Bilberry Extract DIETARY_SUPPLEMENT

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.

Mirtoselect Dietary Supplement

Virtiva Plus Ginko Biloba Extract DIETARY_SUPPLEMENT

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.

Virtiva Dietary Supplement

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 25 to 55 years
• 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.

You may not qualify if:

• 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
• History of neurological disorders
• History of gastrointestinal disorders that could lead to uncertain absorption of the study supplements
• 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 breastfed within 3 months prior to enrollment
• Use of prescription medications that impact digestion
• History or current alcohol or drug abuse
• Has significant concurrent illnesses (controlled or uncontrolled)
• Participation in any other investigational study within 30 days prior to consent

Sponsors & Collaborators

• Applied Science & Performance Institute: lead

Study Sites (1)

Applied Science and Performance Institute

Tampa, Florida, 33607, United States

Location

Study Officials

• Jacob Wilson, Ph.D.

  The Applied Science and Performance Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start: February 21, 2024
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

US (1)