Vitamin (VIT) for Vigilance Study

NCT05574530 | Unknown

• 1 other identifier: NL75954.091.20
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Change; Stress

Keywords

Colon-delivered multivitamin supplement; Cognitive performance; Vigilance

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• Change in forward digit span (DS) score

  Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)

• Change in attention-switching task score

  Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)

• Change in Go-NoGo task score

  Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)

• Change in overall cognitive performance score

  Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)

• Change in stress level

  Baseline (before supplementation (T0)), after 5 weeks (T1) and after a field exercise after 6 weeks (T2)

Study Arms (2)

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.

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.

Dietary Supplement: Placebo supplement

Interventions

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).

Colon-delivered multivitamin supplement

Placebo supplement DIETARY_SUPPLEMENT

6-week intervention of one dietary supplement a day, containing 200 mg of microcrystalline cellulose.

Placebo supplement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University and Research: lead
• Radboud University Medical Center: collaborator
• Dutch Ministry of Defense: collaborator
• DSM: collaborator
• Thales: collaborator
• Circadian: collaborator

Study Sites (1)

Stichting Wageningen Research

Wageningen, Gelderland, 6708 WG, Netherlands

RECRUITING

Central Study Contacts

Diederik Esser, PhD

CONTACT

+31 (0)317 489010; diederik.esser@wur.nl

Jurriaan Mes, PhD

CONTACT

+31 (0)317 481174; jurriaan.mes@wur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplements are labeled A and B by a scientist who is not involved in this trial.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project leader clinical trials

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: October 12, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)