A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EnXtra® and EnXtra® + Caffeine on Mental Alertness and Fatigue in Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 128
- Locations
- 6
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Time Frame: Day 15 at 0, 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
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.
Time Frame: Day 48 at 1, 3 and 5 hours ± 15 minutes post IP
The Attention Network Test (ANT) is an assessment tool to evaluate efficacy of three distinct attention networks: alerting, orienting, and executive networks. Alerting effect = mean Response Time (RT) (correct no cue) - mean RT (correct centre cue) Orienting effect = mean RT (correct centre cue) - mean RT (correct spatial cue) Conflict effect = mean RT (correct incongruent) - mean RT (correct congruent) Correct: correctness of response No cue condition: participant does not receive any cue before the target stimulus appears. Spatial cue is usually presented in the form of an arrow, pointing in the location where the target stimulus will show up. Centre cue condition, A cue appears at the screen's center just before the target stimulus. Incongruent: The target stimulus is flanked by distractors oriented in the opposite direction. Congruent: The target stimulus is flanked by distractor stimuli oriented in the same direction.
Secondary Outcomes
- 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.(Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP)
- To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Complete Blood Count - CBC(Screening and Day 48)
- 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.(Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP)
- 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.(Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP)
- To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Liver Function Tests (LFT)(Screening and Day 48)
- To determine the safety of EnXtra® and EnXtra® + Caffeine as assessed by the Kidney Function Tests (KFT)(Screening and Day 48)
- 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.(Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP)
- 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.(Day 0; Day 5; Day 10; Day 15 - 0, 1, 3 & 5 hours ±15 minutes post IP)
- 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.(Day 20 - 0 hours, Day 48 - 1, 3 & 5 hours ±15 minutes post IP)