Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2023
CompletedMay 15, 2025
May 1, 2025
8 months
January 19, 2023
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
To evaluate the efficacy of the intervention in improving Fatigue.
28 days
To evaluate the efficacy of the intervention in improving Fatigue.
28 days
To evaluate the efficacy of the intervention in improving Focus
28 days
To evaluate the efficacy of the intervention in improving Vigor.
28 days
To evaluate the efficacy of the intervention in improving Focus
28 days
- +2 more secondary outcomes
Other Outcomes (3)
To evaluate the effect of the intervention on blood levels of vitamins B6 & B9
28 days
To evaluate the effect of the intervention on blood levels of vitamins B12
28 days
To evaluate the effect of the intervention on blood levels of taurine
28 days
Study Arms (2)
Investigational Product (Capsules with B vitamins & taurine)
EXPERIMENTALIP will be administered orally once daily in capsule form, ideally between conventional mealtimes (i.e., breakfast, lunch, supper).
Microcrystalline cellulose placebo
PLACEBO COMPARATORPlacebo will be administered orally once daily in identical capsule form as the IP, ideally between conventional mealtimes (i.e., breakfast, lunch, supper).
Interventions
Administered orally in a span of 28 days between mealtimes
Administered orally in a span of 28 days between mealtimes
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philippine General Hospital
Philippines, 1004, Philippines
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veeda M Anlacan, MD
University of the Philippines
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2023
First Posted
February 17, 2023
Study Start
March 8, 2023
Primary Completion
October 25, 2023
Study Completion
December 3, 2023
Last Updated
May 15, 2025
Record last verified: 2025-05