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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
240
Oral capsules
Oral capsules
Atlantia clinical trials
Cork, Ireland
Perceived stress
Change in Perceived Stress Visual Analog Scale (VAS) in response to TSST
Time frame: Before, during, and after TSST at visit 2 (week 8)
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.
Time frame: Before and after TSST at visit 2 (week 8)
PSS score
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.
Time frame: 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.
Time frame: baseline and week 8
Anxiety
Change in Anxiety Visual Analog Scale (VAS) in response to TSST
Time frame: Before, during, and after TSST at visit 2 (week 8)
Emotional insecurity
Change in Emotional Insecurity Visual Analog Scale (VAS) in response to TSST
Time frame: Before, during, and after TSST at visit 2 (week 8)
Exhaustion
Change in Exhaustion Visual Analog Scale (VAS) in response to TSST
Time frame: Before, during, and after TSST at visit 2 (week 8)
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