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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05733364
• Other study ID #: 21.11.DAI
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Capsules with B vitamins & taurine
Administered orally in a span of 28 days between mealtimes

Other:
• Microcrystalline cellulose placebo
Administered orally in a span of 28 days between mealtimes

Locations

Country	Name	City	State
Philippines	Philippine General Hospital	Philippines

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	28 days
Other	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).	28 days
Other	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)	28 days
Primary	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	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.)	28 days
Secondary	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.)	28 days
Secondary	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.	28 days
Secondary	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.)	28 days
Secondary	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)	28 days
Secondary	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)	28 days
Secondary	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.)	28 days