Assessment of Efficacy & Safety of Stadice for Enhancement of Cognitive Abilities
- Registration Number
- CTRI/2023/08/056109
- Lead Sponsor
- Zeushygia Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Participants must self-assess themselves as being in good health.
2. Participants must be regular virtual/mobile/computer/laptop game players or E-game players.
3. Aged 18 to 45 years of both male and female at the time of giving consent.
Subjects meeting any of the following criteria will be excluded from
the study:
1. Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
2. Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2.
3. Are pregnant, seeking to become pregnant or lactating.
4. Have learning and/or behavioral difficulties such as dyslexia or ADHD.
5. Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness)
6. Smoke tobacco or vape nicotine or use nicotine replacement products >2 times per day.
7. Excessive caffeine intake ( >500 mg per day)
8. Have taken antibiotics or dietary supplements e.g., Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is
possible following a 4-week supplement washout prior to participating and for the duration of the study)
9. Are currently participating in other clinical or nutrition intervention studies or have in the past 4 weeks.
10. Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 01 month.
11. Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 01 month.
12. Suffers from frequent migraines that require medication (more than or equal to 1 per month)
13. sleep disorders or are taking sleep aid medication.
14. Are non-compliant with regards treatment consumption
15. An inability to speak with study personnel via Zoom or do not have a private area to perform the study activities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive domain - Definition - Test <br/ ><br>1. Mood - Measurement of subjective feelings - Bond &Lader Mood Scales <br/ ><br>2.Attention & Vigilance -Attention-Ability to <br/ ><br>concentrate on selected <br/ ><br>aspects of environment & <br/ ><br>Vigilance - Simple Reaction <br/ ><br>Time <br/ ><br>3.Executive function - <br/ ><br>Cognitive Responses - Stroop Test <br/ ><br>4.Episodic Memory - Ability to retain memories - Delayed & <br/ ><br>immediate word recall <br/ ><br>5.Working Memory - Ability to retain information - Corsi Block test <br/ ><br>6. Location learning - Visual Memory - Computerized <br/ ><br>location learning & Recall <br/ ><br>Timepoint: Day 1 & DAY 7 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Psychological stress response. Modulation of the psychological response to acute stress (change in: Stress on the afore mentioned mood measures during the OMS) <br/ ><br>as a consequence of the OMS. <br/ ><br>2.Mood measures- State Trait Anxiety Inventory (STAI). (20-80; higher is more anxious) <br/ ><br>POMS shall be used to identify the baseline of Mood measures- Profile of Mood States (POMS)1 <br/ ><br>3.Cognitive Function- Individual task Physiological stress response- Adrenaline Blood Markers i.e., plasma Cortisol taken baseline & end of study in both periods (50% subjects).Timepoint: Day 1 & Day 7