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The study investigates the effects of probiotics in a young healthy population experiencing stress during a stress challenge, i.e. The Trier Social Stress Test (TSST).
The study is a prospective, randomized, double-blind, three-arm, placebo-controlled study in young adults who are moderately stressed and undergoing a Trier Social Stress Test (TSST), comparing probiotics with placebo. The participants will receive either one of the two test products or placebo daily for a period of eight weeks.
At Visit 1, the participants will be dispensed with study product and complete the Cohen's Perceived Stress Scale (PSS) and State Trait Anxiety Inventory (STAI) questionnaires. Blood samples will be collected for biomarker analysis.
At Visit 2, participants will undergo a TSST and will complete the PSS and STAI questionnaires and Visual Analog Scales (VAS). Saliva and blood samples will be collected for biomarker analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics combined strains | Experimental | Probiotics combined strains administered as oral capsules once daily |
|
| Probiotics single strain | Experimental | Probiotics single strain administered as oral capsules once daily |
|
| Placebo | Placebo Comparator | Placebo capsule administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Oral capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived stress | Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| STAI score | Change in State-Trait Anxiety Index (STAI) in response to TSST. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. | Before and after TSST at visit 2 (week 8) |
| PSS score |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol | Salivary cortisol levels in response to TSST | Before, during, and after TSST at visit 2 (week 8) |
| Inflammatory biomarker IL-6 | Blood inflammatory biomarkers from baseline to week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Dinan, Professor | Atlantia Clinical Trials Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia clinical trials | Cork | Ireland |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Oral capsules |
|
Change in Cohen's Perceived Stress Scale (PSS) from baseline to week 8. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
| baseline and week 8 |
| STAI score | Change in State-Trait Anxiety Index (STAI) from baseline to week 8. Individual scores on the STAI can range from 40 to 160 with higher scores indicating higher anxiety. | baseline and week 8 |
| Anxiety | Change in Anxiety Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) |
| Emotional insecurity | Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) |
| Exhaustion | Change in Exhaustion Visual Analog Scale (VAS) in response to TSST | Before, during, and after TSST at visit 2 (week 8) |
| baseline and week 8 |
| Inflammatory biomarker IL-10 | Blood inflammatory biomarkers from baseline to week 8 | baseline and week 8 |
| D019602 |
| Food and Beverages |