Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-10-12
2023-07-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Colon-delivered multivitamin supplement
Colon-delivered multivitamin mix with vitamin B2, B3, B6, B9, vitamin C and D3. These vitamins are delivered as capsules coated by a eudragit S100 coating layer, in order to prevent systemic absorption of the vitamins in the small intestine.
Colon-delivered multivitamin supplement
6-week intervention of one dietary supplement a day, containing vitamin B2 (10mg), vitamin B3 (4mg), vitamin B6 (1.4mg), vitamin B9 (400μg), vitamin C (200mg) and vitamin D3 (15ug).
Placebo supplement
Placebo supplement containing microcrystalline cellulose, coated in the same way as the experimental product in order to prevent systemic absorption in the small intestine.
Placebo supplement
6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose.
Interventions
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Colon-delivered multivitamin supplement
6-week intervention of one dietary supplement a day, containing vitamin B2 (10mg), vitamin B3 (4mg), vitamin B6 (1.4mg), vitamin B9 (400μg), vitamin C (200mg) and vitamin D3 (15ug).
Placebo supplement
6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Dutch Ministry of Defense
UNKNOWN
DSM
UNKNOWN
Thales
UNKNOWN
Circadian
UNKNOWN
Wageningen University and Research
OTHER
Responsible Party
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Diederik Esser
Project leader clinical trials
Locations
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Stichting Wageningen Research
Wageningen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL75954.091.20
Identifier Type: -
Identifier Source: org_study_id
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