Vitamin (VIT) for Vigilance Study

Phase

N/A

Condition

Stress

Treatment

N/A

Clinical Study ID

NCT05574530

NL75954.091.20

Ages 18-50
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Food allergies or other issues with foods that would preclude intake of the studyproducts
History of gastro-intestinal surgery or gastro-intestinal complaints orgastrointestinal 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 antirejectionmedications, on a steroid for >30 days, or chemotherapy or radiotherapy within thelast 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 thestudy 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 recentexperimental trial, these must have been completed not less than 60 days prior to thisstudy.

Study Design

October 12, 2022

July 01, 2023

Study 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.

Connect with a study center

Stichting Wageningen Research
Wageningen, Gelderland 6708 WG
Netherlands
Active - Recruiting

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