a study to evaluate the effect of enxtra® and enxtra® + caffeine on mental alertness and fatigue in healthy individuals

Conditions: Fatigue; Mental Alertness

Summary: acute stage: the present study is a randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study. approximately not more than 170 individuals will be screened and considering a screening failure rate of 25%, approximately 128 individuals will be randomized in a ratio of 1:1:1:1 to receive one of the ips and will be assigned a unique randomization code. in this stage, approximately 114 individuals will complete the study, after accounting for a dropout/withdrawal rate of 15%. the intervention duration is 4 days \[1 (single dose) x 4 periods\]. sub-acute stage: the present study is a randomized, double-blind, placebo-controlled, 4 arms, parallel study. in this stage, approximately 112 individuals will be re-randomized in a ratio of 1:1:1:1 to receive one of the ips and will be assigned a unique randomization code. each group will have not less than 24 completed participants after accounting for a dropout/withdrawal rate of 15%. the intervention duration is 28 days.


Eligibility criteria:
inclusion criteria: * males and females aged between 18 and 40 years. * individuals who have night sleep of 8±1 hours. * individuals with bmi ≥ 18 and ≤ 29.9 kg/meter square * alertness score (jin fan's ant) of 50±20 ms after 24 hours of caffeine abstinence. * individuals habituated to have at least 2 cups of coffee in a day. * individuals with a feeling of sleepiness having karolinska sleepiness scale (kss) of more than 7 during caffeine abstinence. * individuals who fit in physical examination, vital signs and all screening tests are within acceptable limits, according to the physician/investigator's opinion. * individuals having computer literacy to perform the required assessments. * individuals willing to provide signed consent. exclusion criteria: * individuals diagnosed with sleep disorders secondary to another health problem. * individuals with a trait of excessive food cravings. * history of consumption of psychedelic drugs. * individuals who are caffeine dependent i.e. having a history of more than 3 cups (≥200 ml) in a day. * individuals taking energy/ cognitive/ sedative supplements and are unwilling to stop taking those supplements for the duration of the study period. * recent history of physical, emotional, and social trauma within the last three months. * individuals who consume pain-relieving medications more than once per week. * use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, or any illicit drugs. * gastrointestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (\<3 months before inclusion). * recent (\<3 months before inclusion) change in lifestyle (food, body weight, sport, drug, and dietary supplement). * addiction or history of substance abuse. * consumption of more than 3 units of alcohol per day. (one unit is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer) * abnormal thyroid stimulating hormone (tsh) value which is less than 0.40 or more than 5.0 μiu/ml. * known diabetics. * hypertensives defined as sbp more than 140 mm hg and/or dbp more than 90 mm hg with or without anti-hypertensives. * use another investigational product within 90 days of the screening visit. * individuals with a history of or complications from malignant tumors. * history of any significant neurological and psychiatric condition that may affect the participation and inference of the study's endpoints. * females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. * any condition that could, in the opinion of the investigator, preclude the individual's ability to successfully and safely complete the study or that may confound study outcomes.