Clinical trial NCT06560008: A Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Mental Alertness
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Enovate Biolife Pvt Ltd
First posted: 2024-08-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acute stage: Randomized, double-blind, placebo-controlled, single-dose, 4-way, cross-over, study Sub-Acute Stage: Randomized, double-blind, placebo-controlled, 4 arms, parallel study
Primary purpose: OTHER

Brief 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.

Primary outcomes:
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
timeFrame: Day 0 at 0, 1, 3 and 5 hours ± 15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
timeFrame: Day 5 at 0, 1, 3 and 5 hours ± 15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
timeFrame: Day 10 at 0, 1, 3 and 5 hours ± 15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Acute stage.
timeFrame: Day 15 at 0, 1, 3 and 5 hours ± 15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
timeFrame: Day 20 at 0 hours post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on alertness score as assessed by the change in the Jin Fan Alertness score as compared to placebo and caffeine in Sub-acute stage.
timeFrame: Day 48 at 1, 3 and 5 hours ± 15 minutes post IP
Secondary outcomes:
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Acute stage.
timeFrame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Eye-hand coordination as assessed by Nine hole peg test (NHPT) as compared to placebo and caffeine in Sub-acute stage.
timeFrame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in acute stage.
timeFrame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Sustained attention as assessed by Continuous Performance test (CPT) as compared to placebo and caffeine in sub-acute stage.
timeFrame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in acute stage.
timeFrame: Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the effect of EnXtra® and EnXtra® + Caffeine on Fatigue as assessed by the change in the Samn-Perelli fatigue scale (SPS) compared to placebo and caffeine in sub-acute stage.
timeFrame: Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP
measure: To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Complete Blood Count - CBC
timeFrame: Screening and Day 48
measure: To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Liver Function Tests (LFT)
timeFrame: Screening and Day 48
measure: To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Kidney Function Tests (KFT)
timeFrame: Screening and Day 48
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: New Manak Healcare Hospital
state: Maharashtra
city: Thāne
country: India
facility: Gurukrupa Hospital
state: Maharashtra
city: Thāne
country: India
facility: Kalpana Hospital
state: Maharashtra
Study officials:
References: