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

Vedic Lifesciences

Status: Not yet enrolling

Conditions: Mental Alertness; Fatigue

Treatments: Dietary Supplement: EnXtra® (300 mg) + Caffeine (200 mg); Dietary Supplement: Caffeine (200 mg) + Placebo (300 mg); Dietary Supplement: EnXtra® (300 mg) + Placebo (300 mg); Dietary Supplement: Placebo (MCC 300 mg) + Placebo (300 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06560008

EB/240403/ENXTRA/CSF

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

EnXtra® (300 mg) + Placebo (300 mg)

Active Comparator group

Description:

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

Treatment:

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

Caffeine (200 mg) + Placebo (300 mg)

Active Comparator group

Description:

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

Treatment:

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

EnXtra® (300 mg) + Caffeine (200 mg)

Active Comparator group

Description:

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

Treatment:

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

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

Placebo Comparator group

Description:

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

Treatment:

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