Clinical trial NCT05733364: Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
Official title: Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy Working Adults
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the efficacy of the intervention in improving Motivation
timeFrame: 28 days
Secondary outcomes:
measure: To evaluate the efficacy of the intervention in improving Fatigue.
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Fatigue.
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Focus
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Vigor.
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Focus
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Motivation
timeFrame: 28 days
measure: To evaluate the efficacy of the intervention in improving Vigor.
timeFrame: 28 days
Other outcomes:
measure: To evaluate the effect of the intervention on blood levels of vitamins B6 & B9
timeFrame: 28 days
measure: To evaluate the effect of the intervention on blood levels of vitamins B12
timeFrame: 28 days
measure: To evaluate the effect of the intervention on blood levels of taurine
timeFrame: 28 days
Locations:
city: Philippines
country: Philippines
facility: Philippine General Hospital
Study officials:
affiliation: University of the Philippines
name: Veeda M Anlacan, MD
role: PRINCIPAL_INVESTIGATOR
References: