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

NCT ID: NCT05733364

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2023-12-03

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Investigational Product (Capsules with B vitamins & taurine)

IP will be administered orally once daily in capsule form, ideally between conventional mealtimes (i.e., breakfast, lunch, supper).

Group Type: EXPERIMENTAL

Capsules with B vitamins & taurine

Intervention Type: DIETARY_SUPPLEMENT

Administered orally in a span of 28 days between mealtimes

Microcrystalline cellulose placebo

Placebo will be administered orally once daily in identical capsule form as the IP, ideally between conventional mealtimes (i.e., breakfast, lunch, supper).

Group Type: PLACEBO_COMPARATOR

Microcrystalline cellulose placebo

Intervention Type: OTHER

Administered orally in a span of 28 days between mealtimes

Interventions

Capsules with B vitamins & taurine

Administered orally in a span of 28 days between mealtimes

Intervention Type: DIETARY_SUPPLEMENT

Microcrystalline cellulose placebo

Administered orally in a span of 28 days between mealtimes

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veeda M Anlacan, MD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines

Locations

Philippine General Hospital

Philippines, , Philippines

Countries

Philippines

Other Identifiers

21.11.DAI

Identifier Type: -

Identifier Source: org_study_id