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

Nestlé

Status: Active, not recruiting

Conditions: Healthy

Treatments: Other: Microcrystalline cellulose placebo; Dietary Supplement: Capsules with B vitamins & taurine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05733364

21.11.DAI

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Investigational Product (Capsules with B vitamins & taurine)

Experimental group

Description:

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

Treatment:

Dietary Supplement: Capsules with B vitamins & taurine

Microcrystalline cellulose placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Microcrystalline cellulose placebo