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CompletedNCT05733364Updated May 15, 2025

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

An interventional study of Capsules with B vitamins & taurine and Microcrystalline cellulose placebo in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Philippines. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy Working Adults
03

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    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).

    Dietary Supplement: Capsules with B vitamins & taurine

  • Placebo comparator
    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).

    Other: Microcrystalline cellulose placebo

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

06

What researchers measure

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 %

    Time frame: 28 days

Secondary outcomes

  1. 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.)

    Time frame: 28 days

  2. 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.)

    Time frame: 28 days

  3. 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.

    Time frame: 28 days

  4. 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.)

    Time frame: 28 days

  5. 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)

    Time frame: 28 days

  6. 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)

    Time frame: 28 days

  7. 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.)

    Time frame: 28 days

Other outcomes

  1. To evaluate the effect of the intervention on blood levels of vitamins B6 & B9

    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).

    Time frame: 28 days

  2. To evaluate the effect of the intervention on blood levels of vitamins B12

    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).

    Time frame: 28 days

  3. To evaluate the effect of the intervention on blood levels of taurine

    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)

    Time frame: 28 days

07

Study locations

1 site
  • Philippine General Hospital
    Philippines, 1004, Philippines
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05733364
Lead sponsor
Société des Produits Nestlé (SPN)
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Mar 8, 2023
Primary completion
Oct 25, 2023
Completion
Dec 3, 2023
Last update
May 15, 2025

Study contacts

Veeda M Anlacan, MD
principal investigator · University of the Philippines

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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