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The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects

The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects - VIT for vigilance study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52332
Enrollment
90
Registered
2022-06-29
Start date
2022-10-28
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitief functioneren cognitive functioning

Interventions

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

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Healthy men and women * Aged between 18-50 years old * Participating in military field exercise * BMI between 18.5 - 30 kg/m2 * Stable body weight (

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The main study outcome is the backward digit span (DS) score, during the field exercise as compared to the start of the 6-week supplementation period.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)