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Vitamin (VIT) for Vigilance Study

NCT05574530 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-02-08

No results posted yet for this study

Summary

This study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions.

The study is a randomized, double-blind, placebo-controlled, parallel trial in a real-life setting (military field exercise). The intervention product is a nutritional supplement, composed of vitamins B2, B3, B6, B9, C, and D3. These vitamins will be delivered in the colon where most of these vitamins can be utilized by the gut microbiota, as they act as cofactors for important cellular functions.

The main study outcome is the backward digit span (DS) score in a cognitive test, during the field exercise as compared to the start of the 6-week supplementation period. Secondary parameters are other cognitive test scores and a combined (z-scored) cognitive performance score. Stress levels will be measured in salivary cortisol and self-perceived stress levels will be derived from the HADS and PSS-10 questionnaire. Other stress biomarkers (e.g. heart rate variability) will be measured by a wearable.

Conditions

  • Cognitive Change
  • Stress

Interventions

DIETARY_SUPPLEMENT

Colon-delivered multivitamin supplement

6-week intervention of one dietary supplement a day, containing vitamin B2 (10mg), vitamin B3 (4mg), vitamin B6 (1.4mg), vitamin B9 (400μg), vitamin C (200mg) and vitamin D3 (15ug).

DIETARY_SUPPLEMENT

Placebo supplement

6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Dutch Ministry of Defense

    collaborator UNKNOWN

  • DSM

    collaborator UNKNOWN

  • Thales

    collaborator UNKNOWN

  • Circadian

    collaborator UNKNOWN

  • Wageningen University and Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574530 on ClinicalTrials.gov