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

NCT06560008 | Completed

• 1 other identifier: EB/240403/ENXTRA/CSF
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Fatigue; Mental Alertness

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  Day 0 at 0, 1, 3 and 5 hours ± 15 minutes post IP

• 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.

  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.

  Day 5 at 0, 1, 3 and 5 hours ± 15 minutes post IP

• 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.

  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.

  Day 10 at 0, 1, 3 and 5 hours ± 15 minutes post IP

• 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.

  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.

  Day 15 at 0, 1, 3 and 5 hours ± 15 minutes post IP

• 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.

  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.

  Day 20 at 0 hours post IP

• 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.

  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.

  Day 48 at 1, 3 and 5 hours ± 15 minutes post IP

Secondary Outcomes (9)

• 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 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 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

• 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

Study Arms (4)

EnXtra® (300 mg) + Placebo (300 mg)

ACTIVE COMPARATOR

Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days

Dietary Supplement: EnXtra® (300 mg) + Placebo (300 mg)

Caffeine (200 mg) + Placebo (300 mg)

ACTIVE COMPARATOR

Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days

Dietary Supplement: Caffeine (200 mg) + Placebo (300 mg)

EnXtra® (300 mg) + Caffeine (200 mg)

ACTIVE COMPARATOR

Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days

Dietary Supplement: EnXtra® (300 mg) + Caffeine (200 mg)

Placebo (MCC 300 mg) + Placebo (300 mg)

PLACEBO COMPARATOR

Acute Stage: Two capsules to be taken after breakfast orally 1 (single dose) x 4 periods = 4 days Sub-acute Stage: Two capsules to be taken after breakfast orally once a day for 28 days

Dietary Supplement: Placebo (MCC 300 mg) + Placebo (300 mg)

Interventions

EnXtra® (300 mg) + Placebo (300 mg) DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

EnXtra® (300 mg) + Placebo (300 mg)

Caffeine (200 mg) + Placebo (300 mg) DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

Caffeine (200 mg) + Placebo (300 mg)

EnXtra® (300 mg) + Caffeine (200 mg) DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

EnXtra® (300 mg) + Caffeine (200 mg)

Placebo (MCC 300 mg) + Placebo (300 mg) DIETARY_SUPPLEMENT

Two capsules to be taken after breakfast orally once a day (4 single doses in Acute stage and for 28 days in sub-acute stage)

Placebo (MCC 300 mg) + Placebo (300 mg)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead
• Enovate Biolife Pvt Ltd: collaborator

Study Sites (3)

New Manak Healcare Hospital

Navi Mumbai, Maharashtra, 400706, India

Location

Gurukrupa Hospital

Thane, Maharashtra, 400601, India

Location

Kalpana Hospital

Thane, Maharashtra, 400601, India

Location

MeSH Terms

Conditions

Fatigue

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 19, 2024
• Study Start: October 10, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)