HealthyNCT05733364
Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
A study testing Capsules with B vitamins & taurine in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Capsules with B vitamins & taurine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 sitePhilippines
- Study dates
- 8 Mar 2023to 3 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Capsules with B vitamins & taurine, Microcrystalline cellulose placebo
- Keywords
- Healthy Working Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsules with B vitamins & taurineDietary supplement
Administered orally in a span of 28 days between mealtimes
Microcrystalline cellulose placeboOther
Administered orally in a span of 28 days between mealtimes
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product (Capsules with B vitamins & taurine) | Experimental | IP will be administered orally once daily in capsule form, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). Receives: Dietary Supplement: Capsules with B vitamins & taurine |
| Microcrystalline cellulose placebo | Placebo comparator | Placebo will be administered orally once daily in identical capsule form as the IP, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). Receives: Other: Microcrystalline cellulose placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: 28 days
Secondary outcomes (7)
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.)
Measured: 28 days
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.)
Measured: 28 days
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.
Measured: 28 days
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.)
Measured: 28 days
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)
Measured: 28 days
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)
Measured: 28 days
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.)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start8 Mar 2023
- Primary completion25 Oct 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veeda M Anlacan, MD, Principal investigator, University of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733364
- Sponsor's protocol ID
- 21.11.DAI
- Status last verified
- May 2025
- First submitted
- 19 Jan 2023
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anlacan VM, Jamora RDG, Krattinger LF, De Longis E, Hartweg M, Steinmann M, Trovo L. A nutritional blend of taurine, vitamins B6, B9, and B12 improves motivated behaviors in healthy adults-a double-blinded randomized clinical trial. Front Nutr. 2026 Mar 11;13:1711478. doi: 10.3389/fnut.2026.1711478. eCollection 2026.
PubMed 41889717
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 4 Weeks Supplementation of a Combination of Vitamin Bs and Taurine on Mental Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT05733364
- Acronym / sponsor ID
- 21.11.DAI
- Conditions
- Healthy
- Keywords
- Healthy Working Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Investigational Product (Capsules with B vitamins & taurine) | Experimental | Dietary Supplement: Capsules with B vitamins & taurineIP will be administered orally once daily in capsule form, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). |
| Microcrystalline cellulose placebo | Placebo comparator | Other: Microcrystalline cellulose placeboPlacebo will be administered orally once daily in identical capsule form as the IP, ideally between conventional mealtimes (i.e., breakfast, lunch, supper). |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsules with B vitamins & taurineAdministered orally in a span of 28 days between mealtimes | Dietary supplement | Investigational Product (Capsules with B vitamins & taurine) |
| Microcrystalline cellulose placeboAdministered orally in a span of 28 days between mealtimes | Other | Microcrystalline cellulose placebo |
Primary outcome
To evaluate the efficacy of the intervention in improving Motivation
Time frame: 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 %
7 secondary outcomes
To evaluate the efficacy of the intervention in improving Fatigue.
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Fatigue.
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Focus
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Vigor.
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Focus
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Motivation
Time frame: 28 days
To evaluate the efficacy of the intervention in improving Vigor.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 41889717Anlacan VM, Jamora RDG, Krattinger LF, De Longis E, Hartweg M, Steinmann M, Trovo L. A nutritional blend of taurine, vitamins B6, B9, and B12 improves motivated behaviors in healthy adults-a double-blinded randomized clinical trial. Front Nutr. 2026 Mar 11;13:1711478. doi: 10.3389/fnut.2026.1711478. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veeda M Anlacan, MD principal investigator
University of the Philippines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsules with B vitamins & taurine in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of the intervention in improving Motivation (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05733364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.