The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects
- Conditions
- cognitief functionerencognitive functioning
- Registration Number
- NL-OMON52332
- Lead Sponsor
- Wageningen Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
* 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 (< 5 kg change) over the past 3-months
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study outcome is the backward digit span (DS) score, during the field<br /><br>exercise as compared to the start of the 6-week supplementation period. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are other cognitive test scores and a combined (z-scored)<br /><br>cognitive performance score. Stress levels will be measured in salivary<br /><br>cortisol and self-perceived stress levels will be derived from the HADS and<br /><br>PSS-10 questionnaire. Other stress biomarkers (e.g. heart rate variability)<br /><br>will be measured by a wearable. </p><br>