NL-OMON52332RecruitingNot Applicable
The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects - VIT for vigilance study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Wageningen Universiteit
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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 (< 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
- •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
- •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
Investigators
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