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

N

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

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

Trial contacts and locations

1

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Central trial contact

Laura Trovò; Elvira S Tolentino

Data sourced from clinicaltrials.gov

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