This current 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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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.
Study objective
This current 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.
Study design
Randomized, double-blind, placebo-controlled, parallel trial in a real-life
setting (field exercise or intensive training).
Intervention
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.
Study burden and risks
This study is performed in military subjects, but the findings can be
generalized to a larger group of professionals that work in stressful jobs that
require optimal alertness. There are minor risks for the research subjects of
this study. There are no direct benefits for the research subjects. Doses of
the vitamins in the multivitamin supplement are all below the tolerable upper
intake levels (UL) as set for these vitamins. Subjects that will participate in
the study will invest approximately 7 hours during the trial.
Bornse Weilanden 9
Wageningen 6708 WG
NL
Bornse Weilanden 9
Wageningen 6708 WG
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | het traject loopt |
| CCMO | NL75954.091.20 |