Vitamin (VIT) for Vigilance Study

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574530
• Other study ID #: NL75954.091.20
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2023
• Source: Wageningen University and Research
• Contact: Diederik Esser, PhD
• Phone: +31 (0)317 489010
• Email: diederik.esser[@]wur.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Aged between 18-50 years old
• Participating in military field exercise
• BMI between 18.5 - 30 kg/m2
• Stable body weight (< 5 kg change) over the past 3-months;

Exclusion Criteria:

• Food allergies or other issues with foods that would preclude intake of the study products
• History of gastro-intestinal surgery or gastro-intestinal complaints or gastrointestinal diseases (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers)
• Suffering from metabolic, neuro-psychiatric disease (i.e., diabetes, hepatitis, HIV, cancer, epilepsy, major depression, AD(H)D, schizophrenia, etc.)
• Taking medication related to gut diseases or stress
• Being severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
• Use of antibiotics within the previous 3 months
• Not willing to refrain from taking other supplements during the intervention period
• Pregnant, lactating or having a wish to become pregnant during the study
• History of drug and/or alcohol abuse at the time of enrolment
• Using doctor described drugs related to gut or neurological/psychiatric diseases
• Alcohol intake > 3 servings of alcoholic beverages per day
• Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study
• Suffering from an eating disorder
• Vegetarian/vegan diet or other issues with foods that would preclude intake of the study products
• High fibre diet (i.e. >30 g) based on our fibre intake screening tool
• Receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.

Related Conditions & MeSH terms

• Cognitive Change
• Stress

Intervention

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

Locations

Country	Name	City	State
Netherlands	Stichting Wageningen Research	Wageningen	Gelderland

Sponsors (6)

Lead Sponsor	Collaborator
Wageningen University and Research	Circadian, DSM, Dutch Ministry of Defense, Radboud University Medical Center, Thales

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in backward digit span (DS) score	The backward DS score is related to working memory capacity. The score will be obtained from the forward/backward digit span cognitive task.	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in forward digit span (DS) score	The backward DS score is related to working memory capacity. The score will be obtained from the forward/backward digit span cognitive task.	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in attention-switching task score	Measuring interference control and cognitive flexibility	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in Go-NoGo task score	By measuring response inhibition and sustained attention/vigilance	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in overall cognitive performance score	Calculate z-score from all three cognitive tests	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in stress level	Measured in salivary cortisol	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in self-perceived stress levels	Derived from the HADS and PSS10 questionnaire scores	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in dietary fibre intake	Derived from fibre screening questionnaire	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary	Change in sleep quality	Derived from the Pittsburgh Sleep Quality Index questionnaire	Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)