NCT05574530

Vitamin (VIT) for Vigilance Study

A Colon-delivered Multivitamin Supplement to Support Vigilance and Cognitive Performance Under Stressful Working Conditions in Military Subjects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

A growing number of professionals work in a type of job that brings psychological or physical stress while requiring optimal alertness and cognitive control, so called vigilance. These professionals are for example found in military contexts. Even a tiny lapse in alertness can carry large risks for themselves and others. Some studies suggest that dietary supplementation interventions can support shifts in the gut microbiome composition, leading to beneficial effects on various aspects of cognitive performance. The primary objective in this study is 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 hypothesis here is that increased delivery of the nutrients in the colon can support the microbe community and complement microbe metabolites production (e.g. Short Chain Fatty Acids) that via the gut-brain axis support cognitive performance. A secondary objective is to investigate whether 6-week supplementation of the colon-delivered multivitamin mix reduces stress levels during the field exercise and cognitive tests. 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. 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

Type	Name	Description
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.

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2022-10-10
• Last updated: 2023-02-08

Locations

1 site across 1 country: Netherlands