Healthy Adult Participants
Conditions
Keywords
Gut microbiome, Mental well-being, Probiotic, Healthy adults
Brief summary
This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of four weeks of supplementation with a probiotic on mental health in healthy adults aged 18-30 years. Participants will be randomized to receive either probiotic or placebo and will complete study assessments at baseline and end of intervention, and will complete a range of behavioral, physiological, and questionnaire-based assessments before and after the intervention. The primary objective is to assess the effect on emotional reactivity measured in a virtual reality scenario at the end of the intervention. This exploratory study is intended to generate data to inform future clinical research.
Interventions
DIETARY_SUPPLEMENTProbiotic
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
DIETARY_SUPPLEMENTPlacebo
Participants will be instructed to take one capsule once daily in the morning with a meal and water.
Sponsors
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-30 years of age * Native-level Danish language skills * No current psychiatric illness, confirmed with the Presence State Examination (PSE) and the Standardized Assessment of Personality (SAPAS) * No previous history of severe psychiatric illness, including bipolar disorder, recurrent unipolar depression, psychosis spectrum disorders, personality disorders, autism spectrum disorders, or attention deficit (hyperactivity) disorder (ADHD/ADD), confirmed with PSE and SAPAS. Participants may still be included if they have a history of a single depressive episode, or have experienced symptoms of anxiety, stress, or burnout more than 6 months ago.
Exclusion criteria
* Recent use of probiotics (within the past 4 weeks) * Use of antibiotics within the past 3 months * Smoking, chewable tobacco, vaping, or use of other nicotine products * Neurological disorders (including dementia) * Use of psychotropic medication within the previous 6 months, including: * Anxiolytics * Antidepressants * Antipsychotics * Anticonvulsants * Centrally acting corticosteroids * Opioid pain relievers * Hypnotics * Prescribed sleep medications or herbal sleep aids (e.g., valerian) * Dyslexia * Severe physical illness, including: * Cardiovascular disease * Diabetes * Gastrointestinal pathology (e.g., colon cancer, colitis, Crohn's disease) * Gynecological pathology (e.g., endometriosis) * Urologic pathology (e.g., prostate cancer) * Severely immunocompromised status, including: * HIV positive * Being a transplant recipient * Use of anti-rejection medication * Use of steroids for more than 30 days * Chemotherapy or radiotherapy within the last year * Current alcohol or substance abuse disorder * Previous severe head trauma * History of epilepsy * Pregnancy or breastfeeding * Known allergy to any component of the test product * Participation in a clinical study with another investigational product within 60 days before screening, or plans to participate in another study during the study period * Significant change in dietary habits within the previous 4 weeks (e.g., starting a fibre-enriched diet) * Planned major changes in diet or exercise habits during the study period * Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VIRDIS: Rating of unpleasantness in a virtual reality social scenario | This outcome is assessed only at treatment completion (at week 4). | Participants complete a virtual reality-based assessment (VIRDIS) and rate their level of unpleasantness following exposure to a predefined social scenario. Unpleasantness is assessed on a 5-point scale ranging from 1 (not at all unpleasant) to 5 (very unpleasant). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VIRDIS: a composite score of ratings of unpleasantness across all virtual reality scenarios | This outcome is assessed only at treatment completion (at week 4) | This outcome comprises the mean unpleasantness score across all VR scenarios in the VIRDIS test on a scale ranging from 1 (not at all unpleasant) to 5 (very unpleasant). |
| VIRDIS: heart rate | This outcome is assessed only at treatment completion (at week 4). | Heart rate is measured during the VIRDIS assessment (using a wearable physiological monitoring device). Heart rate (pulse) is reported in beats per minute (bpm). Higher scores indicating higher heart rate. |
| Short Form 36 - Energy/Vitality subscale | Change from baseline to treatment completion (at week 4) | The SF-36 questionnaire will be administered in its entirety. The Energy/Vitality subscale (items 23, 27, 29, and 31) is designated as a secondary outcome measure. |
Contacts
CONTACTKamilla Woznica Miskowiak, Professor, DMSc, DPhil
CONTACTAndreas Elleby Jespersen, PhD
PRINCIPAL_INVESTIGATORKamilla Woznica Miskowiak, Professor, DMSc, DPhil
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Outcome results
None listed