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| Name | Class |
|---|---|
| Radboud University Medical Center | OTHER |
| Dutch Ministry of Defense | UNKNOWN |
| DSM | UNKNOWN |
| Thales |
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This 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.
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.
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. Some studies suggest that dietary supplementation interventions can support shifts in the gut microbiome composition, leading to beneficial effects on various aspects of cognitive performance.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colon-delivered multivitamin supplement | Experimental | 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. |
|
| Placebo supplement | Placebo Comparator | Placebo supplement containing microcrystalline cellulose, coated in the same way as the experimental product in order to prevent systemic absorption in the small intestine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon-delivered multivitamin supplement | Dietary 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in backward digit span (DS) score | The backward DS score is related to working memory capacity. The score will be obtained from the forward/backward digit span cognitive task. | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forward digit span (DS) score | The backward DS score is related to working memory capacity. The score will be obtained from the forward/backward digit span cognitive task. | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in attention-switching task score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diederik Esser, PhD | Contact | +31 (0)317 489010 | diederik.esser@wur.nl | |
| Jurriaan Mes, PhD | Contact | +31 (0)317 481174 | jurriaan.mes@wur.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stichting Wageningen Research | Recruiting | Wageningen | Gelderland | 6708 WG | Netherlands |
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| UNKNOWN |
| Circadian | UNKNOWN |
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Supplements are labeled A and B by a scientist who is not involved in this trial.
| Placebo supplement | Dietary Supplement | 6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose. |
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Measuring interference control and cognitive flexibility |
| Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in Go-NoGo task score | By measuring response inhibition and sustained attention/vigilance | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in overall cognitive performance score | Calculate z-score from all three cognitive tests | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in stress level | Measured in salivary cortisol | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in self-perceived stress levels | Derived from the HADS and PSS10 questionnaire scores | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in dietary fibre intake | Derived from fibre screening questionnaire | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |
| Change in sleep quality | Derived from the Pittsburgh Sleep Quality Index questionnaire | Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2) |