Healthy
Conditions
Keywords
Healthy Working Adults
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCapsules with B vitamins & taurine
Administered orally in a span of 28 days between mealtimes
OTHERMicrocrystalline cellulose placebo
Administered orally in a span of 28 days between mealtimes
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of the intervention in improving Motivation | 28 days | 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 % |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of the intervention in improving Focus | 28 days | Capacity to sustain high levels of attention: Psychomotor Vigilance Task. Assessment will be recorded as total number of lapses in absolute number. |
| To evaluate the efficacy of the intervention in improving Fatigue. | 28 days | 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.) |
| To evaluate the efficacy of the intervention in improving Vigor. | 28 days | POMS-SF 2: change in self-reported levels of vigor. Assessment will be recorded as score in arbitrary units (A.U.) |
| To evaluate the efficacy of the intervention in improving Motivation | 28 days | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of the intervention on blood levels of taurine | 28 days | Change in level of taurine in blood at baseline and Day 28 of each administration period. Assessment will be recorded in micromoles per litre (µmol/L) |
| To evaluate the effect of the intervention on blood levels of vitamins B12 | 28 days | Change in level of vitamin B12 in blood at baseline and Day 28 of each administration period. Assessment will be recorded in nanograms per litre (ng/L). |
| To evaluate the effect of the intervention on blood levels of vitamins B6 & B9 | 28 days | Change in level of vitamins B6 & B9 in blood at baseline and Day 28 of each administration period. Assessment will be recorded in microgram per litre (µg/L). |
Countries
Philippines
Outcome results
None listed