Last reviewed · How we verify
NCT05574530
Vitamin (VIT) for Vigilance Study
NA trial testing Colon-delivered multivitamin supplement in Cognitive Change in 90 participants. Status unknown.
1 July 2023
Quick facts
| Lead sponsor | Wageningen University and Research |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 90 |
| Start date | 12 October 2022 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 July 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Colon-delivered multivitamin supplement
- Placebo supplement
Conditions studied
- Cognitive Change — all drugs for Cognitive Change →
- Stress — all drugs for Stress →
Sponsor
Wageningen University and Research
Who can join
Adults 18 to 50, any sex, with Cognitive Change or Stress. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05574530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Colon-delivered multivitamin supplement
Trials testing the same drug.
- NCT05675007 — Effects of a Colon-delivered Multivitamin Supplement on Brain Functioning, Immunometabolic- and Intestinal Markers in Ag · NA · completed
Other recruiting trials for Cognitive Change
Currently open trials in the same condition.
- NCT07147894 — Executive Function Training for Children and Adolescents · NA · recruiting
- NCT07383324 — Heat Stress in Individuals With Schizophrenia · NA · recruiting
- NCT07261202 — Impact of Indoor Overheating on Physiological Strain in Children · NA · recruiting
- NCT07267598 — Suitability of a 26 °C Indoor Environment for Mitigating Heat Strain in Young Adults · NA · recruiting
- NCT07054723 — Surviving Daily Life · recruiting
Other Wageningen University and Research trials
Trials by the same sponsor.
- NCT06945016 — Monitoring Nutritional Consequences of Obesity Treatment on Women's Health · recruiting
- NCT06665464 — Bioavailability of Omega-3 Fatty Acids From Fish Oil Supplements · NA · completed
- NCT05762965 — Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women · NA · completed
- NCT05773625 — JITAIs: Optimization of Effectiveness · NA · completed
- NCT05426122 — Degree of Digestibility of Barley Rice Proteins · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05574530 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wageningen University and Research
- Last refreshed: 8 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05574530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing