Cognitive ChangeNCT05574530
Vitamin (VIT) for Vigilance Study
A study testing Colon-delivered multivitamin supplement in people with Cognitive Change and Stress, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Stress
- What is being tested?
- Colon-delivered multivitamin supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Oct 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG
Jurriaan Mes, PhD, jurriaan.mes@wur.nl
About this study
Official title: A Colon-delivered Multivitamin Supplement to Support Vigilance and Cognitive Performance Under Stressful Working Conditions in Military Subjects
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.
Read the detailed description
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.
- Conditions
- Cognitive Change, Stress
- Being tested
- Colon-delivered multivitamin supplement, Placebo supplement
- Keywords
- Colon-delivered multivitamin supplement, Cognitive performance, Vigilance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon-delivered multivitamin supplementDietary 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 supplementDietary supplement
6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Colon-delivered multivitamin supplement |
| 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. Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Secondary outcomes (8)
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.
Measured: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in attention-switching task score
Measuring interference control and cognitive flexibility
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start12 Oct 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Dutch Ministry of Defense, DSM, Thales, Circadian
- Responsible party
- Principal investigator, Diederik Esser, Wageningen University and Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574530
- Sponsor's protocol ID
- NL75954.091.20
- Status last verified
- Feb 2023
- First submitted
- 6 Oct 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Colon-delivered Multivitamin Supplement to Support Vigilance and Cognitive Performance Under Stressful Working Conditions in Military Subjects
- ClinicalTrials.gov ID
- NCT05574530
- Acronym / sponsor ID
- NL75954.091.20
- Conditions
- Cognitive Change, Stress
- Keywords
- Colon-delivered multivitamin supplement, Cognitive performance, Vigilance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Dutch Ministry of Defense, DSM, Thales, Circadian
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colon-delivered multivitamin supplement | Experimental | Dietary Supplement: Colon-delivered multivitamin supplementColon-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 | Dietary Supplement: Placebo supplementPlacebo supplement containing microcrystalline cellulose, coated in the same way as the experimental product in order to prevent systemic absorption in the small intestine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon-delivered multivitamin supplement6-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). | Dietary supplement | Colon-delivered multivitamin supplement |
| Placebo supplement6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose. | Dietary supplement | Placebo supplement |
Primary outcome
Change in backward digit span (DS) score
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
The backward DS score is related to working memory capacity. The score will be obtained from the forward/backward digit span cognitive task.
8 secondary outcomes
Change in forward digit span (DS) score
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in attention-switching task score
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in Go-NoGo task score
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in overall cognitive performance score
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in stress level
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in self-perceived stress levels
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in dietary fibre intake
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Change in sleep quality
Time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon-delivered multivitamin supplement in people with Cognitive Change and Stress, run by Wageningen University and Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diederik Esser, PhD (+31 (0)317 489010, diederik.esser@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in backward digit span (DS) score (time frame: Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.