A Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals

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.

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.