Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults

Study Overview
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Brief Summary
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To evaluate the efficacy of the intervention in improving Motivation. To evaluate the efficacy of the intervention in improving Fatigue, Motivation/Vigor, Focus/Sustained Attention and blood levels of B vitamins and taurine.

Official Title
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Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Capsules with B vitamins & taurine
* Other: Microcrystalline cellulose placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female, aged 25-40 years, inclusive, at enrolment. Healthy as per site physician/investigator medical assessment based on medical history and physical examination. Body mass index (BMI) between 18.5 to 27.5 kg/m². Able to understand and provide signed informed consent prior to study enrolment. Willing and able to comply with the requirements for participation in this study. Day time workers who work ≥ 8 and ≤ 12 hours per day, and ≤ 60 hours per week. Exclusion Criteria: Any significant ongoing or past medical (including celiac disease, obstructive sleep apnea, restless leg syndrome) and/or psychiatric condition, which in the opinion of the site physician/investigator may compromise participant wellbeing/safety, impede participant compliance with study procedures, or ability to complete the study. Any clinically significant abnormality detected by the site physician/investigator during physical examination conducted at screening. Participants with reported intermediate visual acuity less than 20/25 and without correction. Known history of allergy to the ingredients in the investigational products. Participants that have taken part in another interventional clinical trial within the last 3 months. Current regular smoker (regularity defined ≥2 cigarettes per week). Pregnant, lactating, or intending to conceive during the clinical trial. Use of chronic over the counter or prescription medicines that may affect cognitive and physical functioning within 30 days or 5 half-lives prior to enrolment e.g., antidepressants, anxiolytics, antihistamines, narcotic analgesics. Alcohol consumption above daily recommended alcohol intake for men (2 drinks = 24 g/day) and women (1 drink = 12 g/day) (assessed by self-report; local guidelines) Caffeine consumption above recommended caffeine daily consumption, defined as > 400 mg/day (approximately 4 cups of coffee), and evaluated using the Caffeine Consumption Questionnaire. Consumption of energy drinks containing Taurine and/or Vitamin Bs within 21 days prior to enrolment Use of vitamin Bs and/or Whey protein and/or amino acid supplements within 30 days of enrolment. Presence of sleep disorders (evaluated using the global sleep assessment questionnaire (GSAQ)) Performing shift work or trans-meridian travel within 10 days of enrolment

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, double-blind, placebo-controlled, 2-arm, cross over trial. Participants will receive both the investigational product and placebo, each administered separately for a duration of 28 days, separated by a washout period of 28 days.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product (Capsules with B vitamins & taurine)<br>IP will be administered orally once daily in capsule form, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). | Dietary Supplement: Capsules with B vitamins & taurine<br>* Administered orally in a span of 28 days between mealtimes<br>|
| Placebo Comparator: Microcrystalline cellulose placebo<br>Placebo will be administered orally once daily in identical capsule form as the IP, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). | Other: Microcrystalline cellulose placebo<br>* Administered orally in a span of 28 days between mealtimes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of the intervention in improving Motivation | The mean change from baseline to day 28 of product intake across sessions in the Monetary Incentivized Delay Task (MIDT). Assessment will be recorded as number of success over total in fraction or in % | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of the intervention in improving Fatigue. | Profile of Mood States short-form 2 (POMS-SF 2): change in self-reported levels of fatigue/inertia. Assessment will be recorded as score in arbitrary units (A.U.) | 28 days | 
| To evaluate the efficacy of the intervention in improving Fatigue. | NASA Task Load Index (NASA-TLX): changes in self-reported levels of perceived mental, physical, and temporal demands, self-perceived overall performance, levels of perceived effort exertion and levels of frustration. Assessment will be recorded as score in arbitrary units (A.U.) | 28 days | 
| To evaluate the efficacy of the intervention in improving Focus | Capacity to sustain high levels of attention: Psychomotor Vigilance Task. Assessment will be recorded as total number of lapses in absolute number. | 28 days | 
| To evaluate the efficacy of the intervention in improving Vigor. | POMS-SF 2: change in self-reported levels of vigor. Assessment will be recorded as score in arbitrary units (A.U.) | 28 days | 
| To evaluate the efficacy of the intervention in improving Focus | Capacity to sustain high levels of attention: Psychomotor Vigilance Task. Assessment will be recorded as reaction time in milisecond (ms) | 28 days | 
| To evaluate the efficacy of the intervention in improving Motivation | The mean change from baseline to day 28 of product intake across sessions in the Monetary Incentivized Delay Task (MIDT). Assessment will be recorded as effort or force in kilogram-force (kgf) | 28 days | 
| To evaluate the efficacy of the intervention in improving Vigor. | Self-reported motivation with the Global Motivation Scale: changes in intrinsic motivation, extrinsic motivation, and amotivation. Assessment will be recorded as score in arbitrary units (A.U.) | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Working Adults