Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Applied Science & Performance Institute
Enrollment (Week -4 to Week -3): After obtaining written informed consent participants will undergo screening to ensure they are free of cardiovascular-, neurological-, hepatic-, renal-, metabolic diseases, which will be determined by health history questionnaire. Additionally, as part of screening, participants will be required to have a total Perceived Stress Scale (PSS) score \>13 and \<27 for moderate stress. If they pass the screening tests, they will be given a battery of cognitive assessment tests as part of a familiarization/acquisition phase of testing on a separate day. Familiarization/acquisition phase with computerized cognitive testing, (Week -2): Subjects will undergo an abbreviated version (\~15 minutes) of the computerized cognitive testing to familiarize with the online platform, testing instructions, and cadence of the tests. After completion of the familiarization procedures, subjects will be randomly assigned to one of two study groups (Virtiva® Plus 240 mg/day or Virtiva® Plus 480 mg/day and will be assigned a subject No./ID in the 100 series starting with "101" and continuing in sequential order until enrollment is met. Baseline Testing (Week -1 \[Day -7 to Day -1\]): Prior to receiving their first study treatment, participants will undergo baseline assessments on all study variables. Baseline testing will occur within 7 days of being assigned to their study group. On Day -7, participants will consume a normal breakfast (caffeine and stimulant-free), and undertake a cognitive battery of tests (lasting \~30 min) 3-hours post-breakfast (see these tests under Secondary Endpoints). On Day -6, participants will again consume a normal breakfast, and take multiple survey questionnaires 3-hours post-breakfast (see these tests under Primary Endpoints). Between Days -5 to -1, participants will repeat the survey tests in identical manner on two additional days, for a total of three survey tests taken. The average score of the three survey tests will be used for analysis. The tests may be taken on consecutive days. Study Treatments (Day 1 to Day 35): Participants will be instructed to start their study treatments on Day 1 and continue supplementation for 35+3 days. Endpoint Cognitive Tests (Week 4 \[Days 26 to 28\]): Participants will take one serving of their treatment (120 or 240 mg of Virtiva Plus) with a normal meal. Three hours later, participants will complete all cognitive tests described under the Secondary Endpoints section. These cognitive tests will only be taken on one occasion during these three days (Days 26 to 28). Endpoint Survey Tests (Week 5 \[Days 29 to 35\]): On three separate occasions between Day 29 to Day 35, participants will consume a normal breakfast (caffeine and stimulant-free), plus one serving of their treatment (120 or 240 mg of Virtiva Plus). Three hours post breakfast, participants will complete all survey questionnaires described in the Primary Endpoints section on three separate occasions. The average score of the three survey tests will be used for analysis. The tests may be taken on consecutive days.
Age
50–70
Sex
ALL
Healthy volunteers
Accepted
