Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers

Study Overview
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Brief Summary
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In the present study, Sponsor aim to evaluate the effects of EnXtra® as to improve Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers. A Randomized, Placebo-controlled, Double-blind Crossover Study of 60 randomized cross over for total study duration of approximately 25 days with 5 days of treatment period for each arm and 5-7 days wash out period between both arms.

Official Title
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A Randomized, Placebo-controlled, Double-blind Crossover Study to Evaluate Efficacy of EnXtra on Accuracy & Reaction Time, Perceived Alertness & Digital Fatigue for Video Gamers

Conditions
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Alert Fatigue, Health Personnel

Intervention / Treatment
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* Other: Experimental: EnXtra 300 mg/ capsule
* Other: Microcrystalline cellulose (MCC) 300mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males & Females aged ≥ 18 - ≤ 40 years. Subjects with Body Mass Index (BMI) 18 - 29.9 kg/ m2 Subjects with history of playing video games for 6 or more hours/ week for 6 months before the screening Subject who can read and understand English language with ease. Fasting blood glucose (FBG) ≤ 125 mg/dl Subjects with history of regular sleep and agree to sleep for 8 ±1 hours the night before the visit day. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period. Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days. Subjects willing to refrain from consuming caffeine and caffeine-containing products 24 hour prior to visit days. Willing to participate in the study with a signed and dated written consent. Exclusion Criteria: Subjects suffering from Insomnia. Subjects suffering from chronic fatigue, stress or anxiety. Subjects with uncontrolled hypertension with systolic blood pressure ≥130 and diastolic blood pressure ≥89 mm Hg. Subjects with uncontrolled Type II Diabetes Mellitus with FBG >125 mg/ dl Subjects with Hemoglobin (Hb) ≤ and/or ≥ 13.5 - 17.0 g/Dl inmales and 12.0 - 15.0 g/dL in females. Subjects with ≤ and/or ≥ Total Leucocyte Counts (TLC) 4.0 - 10.0 x 10 3/U Subjects with Differential Leukocyte Counts (DLC) outside the normal range. [Neutrophils: 40 - 80 %, Lymphocytes: 20 - 40 %, Monocytes: 2 - 10 %, Eosinophils: 1 - 6 %, Basophils: 0 - 0.02 %] Subjects with AST values ≤ and/or ≥ 40 U/L in males and 32 U/Lin females. Subjects with ALT values ≤ and/or ≥ 41 U/L in males and 33 U/Lin females Subjects with Creatinine ≤ and/or ≥ Males: 59-104 μmol/L in males and 45-84 μmol/L in females History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders. Chronic Alcoholics and smokers Subjects taking any medications or preparations to improve gaming performance (herbal, dietary supplements, homeopathic preparations, etc.) and/or cognitive performance during the study. Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator may interfere with evaluations in the study or noncompliance with treatment or visits. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Subjects who have had participated in a study of an investigational product 90 days prior to the screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, Crossover Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EnXtra 300 mg/ capsule<br>One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days | Other: Experimental: EnXtra 300 mg/ capsule<br>* One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days<br>|
| Placebo Comparator: Microcrystalline cellulose (MCC) 300mg<br>One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days | Other: Microcrystalline cellulose (MCC) 300mg<br>* One capsule to be taken 3±0.5 hours prior to second gaming session on Day 1 followed by 1 capsule daily after breakfast for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Accuracy | Reaction Accuracy as assessed by change in the accuracy score for the video game (Call of Duty) as compared to the placebo | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | 
| Reaction Time | Reaction Time as assessed by change in the time to response using stroop effect as compared to the placebo | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIME | Time taken to complete the mission for the video game (Call of Duty) as compared to the placebo | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & 3 hours post IP on Day 5; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & 3 hours post IP on Day 15 | 
| Stanford Sleepiness Scale | Perceived Alertness after video game assessed by change in Stanford Sleepiness Scale (SSS) after video game session, as compared to that of placebo Higher the score is the worst outcome and lowest the score is the better outcome. | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | 
| Multidimensional Fatigue Inventory mental domain scores | Mental fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) mental domain scores at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP & Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | 
| Multidimensional Fatigue Inventory physical domain scores | Physical fatigue as assessed by change in Multidimensional Fatigue Inventory (MFI) physical domain score at the end of the video game, as compared to the placebo The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP, Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP | 
| Multidimensional Fatigue Inventory (MFI) motivation domain scores | Intrinsic motivation for video gaming as assessed by change in the Multidimensional Fatigue Inventory (MFI) motivation domain scores after game session, as compared to placebo. The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. This tool has been tested for its psychometric properties in individuals receiving radiotherapy, those with the chronic fatigue syndrome, psychology students, medical students, army recruits and junior physicians | Day 1 - Pre - IP (Baseline), Day 1 - 3 hours post IP, Day 5 - 3 hours post IP; Day 10 - Pre - IP (Baseline), Day 10 - 3 hours post IP & Day 15 - 3 hours post IP |